Title: A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
Brief Title: ATEMPT 2.0: Adjuvant T-DM1 Vs TH
Brief Summary: This research study is studying how well newly diagnosed breast cancer that has tested
positive for a protein called HER2 responds using one of two different combination of
HER2-directed therapies as a treatment after surgery.
The name of the study drugs involved are:
- Trastuzumab-emtansine (T-DM1, Kadcyla)
- Trastuzumab SC (Herceptin Hylecta)
- Paclitaxel
For info regarding 21-159
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase IB Study of Atezolizumab and Bevacizumab with SBRT for Unresectable Hepatocellular Carcinoma
Brief Title: Atezolizumab+Bevacizumab+SBRT in Unresectable HCC
Brief Summary: This research study is evaluating the safety and tolerability of the drugs atezolizumab
and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable
hepatocellular carcinoma.
This study involves the following interventions:
- Atezolizumab
- Bevacizumab
- Stereotactic body radiation therapy (SBRT)
For info regarding 21-286
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer
Brief Title: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
Brief Summary: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with
Gastrointestinal, Pancreatic, or Colorectal Cancer
For info regarding 19-685
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: MRI Evaluation of Aging Related Changes to the Brain
Brief Title: MRI Evaluation of Aging Related Changes to the Brain
Brief Summary: The purpose of this study is to develop new magnetic resonance imaging (MRI) techniques that can be used to clinically evaluate patients across a spectrum of ages 18+. This study will test magnetic resonance techniques on FDA approved MRI machines. Newly developed MRI sequences will be
validated on normal subject brains and compared to standard techniques. This study will evaluate different brain imaging techniques including Arterial Spin Labeling (ASL) perfusion and Inhomogeneous Magnetization Transfer (ihMT) imaging.
For info regarding 2017P000491
please contact David Alsop at 617-667-0275 or
dalsop@bidmc.harvard.edu
Title: Development of physical therapy telehealth program for patients at risk of falls NIA-JHAITC
Brief Title: NIA-JHAITC
For info regarding 2024P000470
please contact Dennis Anderson, PhD at 617-975-7623 or
danders7@bidmc.harvard.edu
Title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
Brief Title: Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
Brief Summary: The purpose of the clinical study is to investigate whether the local delivery of
bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of
bone coming back to the same location. The hypothesis is that the local administration of
bisphosphonate will decrease the rate of the tumor returning compared to traditional
aggressive surgical removal of the tumor.
For info regarding 21-396
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Prospective multicenter observational study for validation of a pancreatic cancer risk model and assessment of the predictive value of blood biomarkers in a high-risk cohort
Brief Title: Panc CA Risk Model & Biomarker Testing In High-Risk Cohort
Brief Summary: The purpose of this study is to test a double screening strategy for pancreatic cancer,
based on a model developed using patient medical records. Investigators would also like
to test whether adding specific blood tests, can further help identify people who have a
higher risk of pancreatic cancer than the general population, and would benefit from
imaging in order to detect cancer early.
For info regarding 21-490
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an anti CD20 x anti CD3 bispecific monoclonal antibody, and REGN2810, an anti-programmed death 1 monoclonal antibody, in Patients with B cell Malignancies
Brief Title: A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
Brief Summary: This study is researching a combination of 2 experimental drugs, referred to as "study
drugs", called odronextamab (also known as REGN1979) and cemiplimab (also known as
REGN2810). The study is focused on patients who have relapse/refractory aggressive B-cell
lymphoma. The aim of the study is to see how safe and tolerable the study drugs are, and
to define the recommended dose regimen for the combination with odronextamab.
This study is also looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How effective the study drugs are against the disease
- How much study drug is in the blood at different times
- Whether the body makes substances or protein called antibodies against the study
drugs (that could make the drugs less effective or could lead to side effects)
For info regarding 16-232
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1b/2a Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients with Diffuse Large B-cell Lymphoma Receiving Chimeric Antigen Receptor T-cell Therapy
Brief Title: Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
Brief Summary: This is an interventional study to evaluate the use of CTO1681 in preventing or reducing
CAR T-cell-induced toxicities like cytokine release syndrome (CRS). This study will
enroll adult patients with DLBCL who are scheduled to receive CD19-directed CAR T-cell
therapy.
The first phase of the study will be open label with dose escalation. Participants will
start taking CTO1681 just prior to receiving their CAR T-cell therapy and continue to
take the study drug three times daily for a total of 15 days.
For info regarding 24-094
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A phase 2 study of fixed duration therapy with pirtobrutinib and obinutuzumab in previously untreated chronic lymphocytic leukemia (POP)
Brief Title: Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia
Brief Summary: This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given
over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic
leukemia or small lymphocytic lymphoma (CLL or SLL).
For info regarding 24-017
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A phase 2 study of MRD adapted therapy with venetoclax-obinutuzumab in patients
with relapsed or refractory CLL, with addition of acalabrutinib in patients with persistent MRD
Brief Title: Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
Brief Summary: This research study is studying a combination of drugs as a possible treatment for
chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The names of the study drugs involved in this study are:
- obinutuzumab
- venetoclax
- acalabrutinib
For info regarding 19-743
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Trial of Zanubrutinib and Venetoclax in Previously Treated CLL/SLL Patients
Brief Title: Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
Brief Summary: This study is being done to test the effectiveness of zanubrutinib in combination with
venetoclax in participants with previously treated chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL).
For info regarding 21-279
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELLNON-HODGKIN LYMPHOMA (NHL)
Brief Title: A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Brief Summary: This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to
evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.
The study will be conducted in compliance with the International Council on Harmonisation
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.
This study is divided into three periods:
- Pretreatment, which consists of screening assessments, leukapheresis and the
Pretreatment evaluation;
- Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy
and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
- Posttreatment, which includes follow-up assessments for disease status and safety
for 5 years.
For info regarding 20-011
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma
Brief Title: A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma
Brief Summary: This study is evaluating whether an experimental treatment called GLPG5101 helps to treat
non-Hodgkin lymphoma (NHL) and if it is safe to use.
This study will be carried out in 2 phases:
- The first phase is to see which dose of GLPG5101 works best with the least number of
side effects.
- In the second phase, all participants will get the best dose of the first phase.
For info regarding 24-603
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Follicular Lymphoma
Brief Title: A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies
Brief Summary: This study is researching an investigational drug, odronextamab, in adult patients B-cell
non-Hodgkin's lymphoma (B-NHL).
The main purpose of this study is to assess the effectiveness of odronextamab in
destroying cancer cells and to learn more about the safety of odronextamab.
The study is looking at several other research questions, including:
- To see if odronextamab works to destroy cancer cells
- Side effects that may be experienced by people taking odronextamab
- How odronextamab works in the body
- How much odronextamab is present in the blood
For info regarding 19-323
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS
Brief Title: Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Brief Summary: This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for
all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy
participating in a previous Celgene sponsored or Celgene alliance partner sponsored
study.
Participants who received at least one GM T cell infusion will be asked to enroll in this
LTFU protocol upon either premature discontinuation from, or completion of the prior
parent treatment protocol.
For info regarding 17-593
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A First-in-human (FIH) Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Brief Title: NTE001
Brief Summary: This clinical trial is designed to test whether a single stereotactic intracerebral
administration of inhibitory nerve cells into subjects with drug-resistant mesial
temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure
frequency).
For info regarding 2023P000349
please contact Joshua Aronson at
jaronson@bidmc.harvard.edu
Title: Treatment Resistant Depression Subcallosal Cingulate Network DBS
Brief Title: TRANSCEND Study
Brief Summary:
For info regarding 2024P000577
please contact Joshua Aronson at
jaronson@bidmc.harvard.edu
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Chronic Migraine in Adult Participants
Brief Title: C-BEOND
Brief Summary:
For info regarding 2024P000220
please contact Sait Ashina at 617-667-6000 or
sashina@bidmc.harvard.edu
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Episodic Migraine in Adult Participants
Brief Title: E-BEOND
Brief Summary:
For info regarding 2024P000238
please contact Sait Ashina at 617-667-6000 or
sashina@bidmc.harvard.edu
Title: Narrow band green light effects on cortical excitability and responsivity in migraine
Brief Title: Narrow band greenlight
For info regarding 2023P000201
please contact Rami Burstein, PhD at
rburstei@bidmc.harvard.edu
Title: A multicenter access and distribution protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
Brief Title: A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Brief Summary: This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.
For info regarding 11-296
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Multicenter Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
Brief Title: Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
Brief Summary: This study will evaluate the safety of infusion of the investigational cord blood units
by carefully documenting all infusion-related problems.
For info regarding 12-223
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1 Study of vaccination with dendritic cell (DC)/multiple myeloma (MM) fusions in combination with Elranatamab in relapsed or refractory multiple myeloma.
Brief Title: A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
Brief Summary: This research is being done to determine if the combination of the Dendritic Cell (DC)/
Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating
Relapsed or Refractory Multiple Myeloma (MM).
The names of the study drugs and vaccine involved in this study are:
- DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant
tumor cells are fused with harvested participant dendritic blood cells)
- Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor)
- Elranatamab (a type of T-cell engager antibody)
For info regarding 24-439
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A phase 2 study of elranatamab as consolidation after idecabtagene vicleucel in relapsed refractory multiple myeloma
Brief Title: Elranatamab in R/R Multiple Myeloma
Brief Summary: This research is being done to see if the study drug, elranatamab, reduces the risk of
disease progression (worsening disease) after idecabtagene vicleucel in relapsed
refractory multiple myeloma.
For info regarding 23-402
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2, Multicohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2).
Brief Title: An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma
Brief Summary: This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the
efficacy and safety of bb2121 in participants with relapsed and refractory multiple
myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with
talquetamab (Cohort 1b), in participants with multiple myeloma (MM) having progressed
within 18 months of initial treatment with autologous stem cell transplantation (ASCT)
(Cohort 2a) and without ASCT (Cohort 2b) or, in participants with inadequate response
post ASCT during initial treatment (Cohort 2c) and the efficacy and safety of bb2121 used
in combination with lenalidomide maintenance in participants with suboptimal response
post ASCT (Cohort 3). Approximately 264 participants will be enrolled into one of three
cohorts. Cohort 1 (including cohort 1b) will enroll approximately 126 RRMM subjects with
= 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM
subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort
2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not
including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects
with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts
will start in parallel and independently. Cohort 3 will enroll approximately 30 newly
diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.
For info regarding 18-604
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An open-label, first-in-human, dose-escalation/expansion study of SAR443579 administered as single agent by intravenous infusion in adult and pediatric participants with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), high risk-myelodysplasia (HR-MDS), or blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Brief Title: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Brief Summary: This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion
study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic
activity of SAR443579 in various hematological malignancies.
For info regarding 22-289
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: MMRC HORIZON ONE: A PHASE II RANDOMIZED ADAPTIVE PLATFORM TRIAL EVALUATING NOVEL THERAPIES IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA
Brief Title: MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM
Brief Summary: This trial is an adaptive platform trial. The structure of the protocol allows the trial
to evolve over time. Multiple investigational arms will be included within the trial
under a Master Protocol (MP). These investigational arms may be added as appendices at
different times depending on whether they are trial-ready and whether accrual in the
trial will support another arm. Accrual to an arm will terminate in accord with the arm's
appendix to the Master Protocol.
The purpose of this proposed structure is to support the recurrent research challenge of
efficiently evaluating what is the best therapy for a particular patient.
For info regarding 24-476
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase II Multicenter Trial of anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy for Multiple Myeloma Patients with Sub-Optimal Response After Autologous Hematopoietic Cell Transplantation and Maintenance Lenalidomide
Brief Title: MM CAR-T to Upgrade Response BMTCTN1902
Brief Summary: This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell
Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve
post autologous hematopoietic cell transplant (HCT) responses among patients with
multiple myeloma (MM).
For info regarding 21-673
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A prospective, multicenter, randomized, and controlled study to evaluate the safety and effectiveness of the STIMIT ACTIVATOR 1 System
Brief Title: STIMIT
Brief Summary: The study is a prospective, multi-center, randomized, controlled study using adaptive
design to assess the evidence of safety and performance of the STIMIT Activator 1 System
in the treatment of patients who have been mechanically ventilated for up to 48 hours and
are predicted to require additional minimum 48 hours of mechanical ventilation or longer
(adding up to MV time approximately 96 hours or longer).
For info regarding 2023P000981
please contact Elias Baedorf Kassis at 617-667-0000 or
enbaedor@bidmc.harvard.edu
Title: A Phase 2 Study of Avelumab in Combination with Bladder-Directed Radiation in Cisplatin-Ineligible Patients with Muscle-Invasive Urothelial Carcinoma of the Bladder
Brief Title: Avelumab and Radiation in Muscle-Invasive Bladder Cancer
Brief Summary: This research study is studying the effects of adding a certain type of immunotherapy to
standard bladder-directed radiation as a treatment for muscle-invasive urothelial
carcinoma of the bladder.
The drug in this study is: Avelumab (also known as BAVENCIO®)
For info regarding 18-464
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Medacta M-Vizion Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Brief Title: Medacta M-Vizion
Brief Summary: Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem
subsidence in the femoral canal.
For info regarding 2023P000592
please contact Michael Baratz at
mbaratz@bidmc.harvard.edu
Title: Visual restoration of losses caused by cortical damage: a new protocol to promote fast recovery
Brief Title: Reduction of Visual Field Deficits
Brief Summary: This is a randomized, pilot interventional study in participants with visual field
deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes
a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of
one half of the visual field. The goal of this project is to elaborate and refine a
rehabilitation protocol for VFD participants. It is hypothesized that visual restoration
training using moving stimuli coupled with noninvasive current stimulation on the visual
cortex will promote and speed up recovery of visual abilities within the blind field in
VFD participants. Moreover, it is expected that visual recovery positively correlates
with reduction of the blind field, as measured with traditional visual perimetry: the
Humphrey visual field test or an eye-tracker based visual perimetry implemented in a
virtual reality (VR) headset. Finally, although results will vary among participants
depending on the extent and severity of the cortical lesion, it is expected that a bigger
increase in neural response to moving stimuli in the blind visual field in cortical
motion area, for those participants who will show the largest behavioral improvement
after training. The overarching goals for the study are as follows: Group 1a will test
the basic effects of transcranial random noise stimulation (tRNS) coupled with visual
training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic
hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months
post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual
training on a Virtual Reality (VR) device in stroke cohorts, including both
chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will
examine the effects of tRNS alone, without visual training, also including chronic and
subacute VFD stroke participants and longitudinal testing.
For info regarding 2021P000804
please contact Lorella Battelli at 617-667-0203 or
lbattell@bidmc.harvard.edu
Title: Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodules
Brief Title: Avecure Flexible Microwave Ablation Probe For Lung Nodules
Brief Summary: This research study to determine the effectiveness of the AveCure Flexible Microwave
Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.
This research study involves microwave ablation (MWA)
For info regarding 21-412
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
Brief Title: Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
Brief Summary: This research is being done to evaluate the feasibility of the AveCure Flexible Microwave
destruction of tissue (Ablation) Probe for the treatment of malignant central airway
obstruction using a thin, tube-like instrument with a light and a lens for viewing and
removing tissue (bronchoscopic).
The name of the intervention being used in this research study is:
AveCure Flexible Microwave Ablation Probe (handheld, surgical device that delivers
microwave energy via flexible probe tip)
For info regarding 23-131
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Department of Neurology Biorepository
Brief Title: Department of Neurology Biorepository
Brief Summary: The purpose of this study is to collect and store samples (for example, blood and saliva) in patients with different neurologic disorders (for example, Parkinsons Disease, Epilepsy, Stroke) to be used for future research to learn more about diagnosing, preventing and treating neurologic disorders.
For info regarding 2023P000108
please contact Neurology Biorepository Research Team at 617-667-0605 or
NeuroRepository@bidmc.harvard.edu
Title: An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation.
Brief Title: Evaluation of Lasofoxifene Combined with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation
Brief Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the
combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for
the treatment of pre- and postmenopausal women and men who have previously received
ribociclib or palbociclib-based treatment and have locally advanced or metastatic
estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast
cancer with an estrogen receptor 1 (ESR1) mutation.
The main question the study aims to answer is:
• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of
fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral
lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant
500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus
oral abemaciclib 150 mg twice a day.
For info regarding 23-206
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score = 25 (OFSET)
Brief Title: Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
Brief Summary: This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors
and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1
patients).
For info regarding 24-635
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Expectations and Experiences of Narcolepsy Symptoms in Pregnancy
Brief Title: Narcolepsy Symptoms in Pregnancy
Brief Summary: This study seeks to fill the critical knowledge gap on the evidence-based management of narcolepsy type 1 (narcolepsy with cataplexy) during pregnancy. By gathering data on the severity and impact of narcolepsy symptoms before, during, and after pregnancy, this mixed-methods study aims to better define symptom trajectory, treatment approaches, and current gaps in care for pregnant people with narcolepsy. This study will
include an on-line questionnaire plus an optional interview.
For info regarding 2023P001041
please contact Margaret Blattner, MD PhD at 617-667-3237 or
mblattne@bidmc.harvard.edu
Title: A novel protocol for diagnosing idiopathic hypersomnia
Brief Title: Home sleep testing for diagnosing Idiopathic Hypersomnia
For info regarding 2023P000058
please contact Liz Roy at 617-975-7636 or
eroy2@bidmc.harvard.edu
Title: A Phase 1 Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors
Brief Title: A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors
Brief Summary: This study will test the safety of a drug called PF-08046052/SGN-EGFRd2 in participants
with advanced solid tumors. It will also study the side effects of this drug. A side
effect is anything a drug does to the body besides treating the disease.
Participants will have cancer that cannot be removed (unresectable) or has spread through
the body (metastatic).
This study will have three parts. Parts A and B of the study will find out how much
PF-08046052/SGN-EGFRd2 should be given to participants. Part C will use the dose found in
parts A and B to find out how safe PF-08046052/SGN-EGFRd2 is and if it works to treat
solid tumor cancers.
For info regarding 24-241
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS 2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
Brief Title: Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
Brief Summary: The main goal of this first-in-human (FIH) study is to learn about the safety and dosing
of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants
with advanced solid tumors.
The primary objectives of this study are:
- To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in
combination with zimberelimab in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD)
and/or the recommended phase 2 dose (RP2D) of GS-2121 as monotherapy and in
combination with zimberelimab in participants with advanced solid tumors.
For info regarding 24-378
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GS-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti–PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
Brief Title: Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Brief Summary: This is a first-in-human (FIH) study to evaluate the safety and tolerability and to
determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of
denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in
participants with advanced solid tumors.
This study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D:
combination therapy, and Part F for both monotherapy and combination therapy) in
participants with advanced solid tumors who have received, been intolerant to, or been
ineligible for all treatments known to confer clinical benefit or in participants with
select solid tumors.
For info regarding 22-070
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Study of AGEN1423, an Anti-CD73-TGF?-Trap Bifunctional Antibody, in Combination with Botensilimab, with or without Chemotherapy in Subjects with Advanced Pancreatic Cancer.
Brief Title: AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC
Brief Summary: The goal of this research study is to asses the safety and efficacy of the combination of
AGEN1423 and Botensilimab with or without chemotherapies, gemcitabine and nab-paclitaxel,
for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) which has
progressed after at least one previous line of cancer therapy.
The names of the study drugs involved in this study are:
- AGEN1423
- Botensilimab
Participants will receive study treatment for about 2 years and will be followed for 1
year after.
For info regarding 22-213
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase-I Open-Label, Dose-Escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients with Locally Advanced or Metastatic Solid Tumors
Brief Title: A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
Brief Summary: This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the
safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18
when administered as a single agent or in combination with other anti-cancer drugs in
patients with locally advanced or metastatic solid tumors.
For info regarding 23-550
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase 1 dose-escalation trial of OMTX705, an anti-fibroblast activation protein antibody-drug conjugate, as single agent and in combination with anti-PD-1 in patients with advanced solid tumors.
Brief Title: Efficacy and Safety Study of OMTX705, Monotherapy and Pembrolizumab-combined, in Subjects With Advanced Solid Tumors.
Brief Summary: Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the
safety and tolerability of OMTX705, both as monotherapy or in combination with
pembrolizumab in the treatment of patients with advanced or metastatic cancer in whom
there is no available standard therapeutic option.
For info regarding 22-588
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis
Brief Title: Intercept 977-311
Brief Summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose
Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with
Primary Biliary Cholangitis (PBC).
For info regarding 2024P000549
please contact Alan Bonder at 617-632-1070 or
abonder@bidmc.harvard.edu
Title: A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis
Brief Title: Intercept 977-311
Brief Summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose
Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with
Primary Biliary Cholangitis (PBC).
For info regarding 2024P000549
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) (CLIN-60190-453)
Brief Title: CLIN-60190-453
Brief Summary: This study will evaluate the effects of elafibranor (the study drug) in participants with
Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to
injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in
the liver, which then causes further damage, and leads to disease progression. This study
will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial
will be to study the safety and side effects of the study drug. The trial will also study
the study drug's effects on blood tests and other tests related to PSC disease activity.
For info regarding 2023P000297
please contact Alan Bonder at 617-632-1070 or
abonder@bidmc.harvard.edu
Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) (CLIN-60190-453)
Brief Title: CLIN-60190-453
Brief Summary: This study will evaluate the effects of elafibranor (the study drug) in participants with
Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to
injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in
the liver, which then causes further damage, and leads to disease progression. This study
will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial
will be to study the safety and side effects of the study drug. The trial will also study
the study drug's effects on blood tests and other tests related to PSC disease activity.
For info regarding 2023P000297
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Brief Title: Volixibat VLX-301 Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease
progression of PSC.
For info regarding 2021P000450
please contact Julie Shea at 167-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Brief Title: Volixibat VLX-301 Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease
progression of PSC.
For info regarding 2021P000450
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Brief Title: Mirum VLX-601 VANTAGE Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression
of PBC.
For info regarding 2021P000960
please contact Julie Shea at 617-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Brief Title: Mirum VLX-601 VANTAGE Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression
of PBC.
For info regarding 2021P000960
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Brief Title: AFFIRM: CB8025-41837
Brief Summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis.
For info regarding 2023P000565
please contact Alan Bonder at 617-632-1070 or
abonder@bidmc.harvard.edu
Title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Brief Title: AFFIRM: CB8025-41837
Brief Summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis.
For info regarding 2023P000565
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
Brief Title: IDEAL: CB8025-32251
Brief Summary: To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in
Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance
to Ursodeoxycholic Acid (UDCA)
For info regarding 2023P000749
please contact Alan Bonder at 617-632-1070 or
abonder@bidmc.harvard.edu
Title: IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
Brief Title: IDEAL: CB8025-32251
Brief Summary: To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in
Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance
to Ursodeoxycholic Acid (UDCA)
For info regarding 2023P000749
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: Eyecontrol coMmunication platform for dEliRium manaGemEnt in intensive care units (EMERGE) : A Multicenter Randomized Controlled Trial
Brief Title: EMERGE
Brief Summary: The purpose of this research is to investigate whether addition of the EyeControl-Pro
platform as an adjunct to standard guideline-based intensive care unit management of
critically ill patients is effective in reducing delirium incidence and severity.
For info regarding 2023P000563
please contact Somnath Bose at 617-667-7600 or
sbose2@bidmc.harvard.edu
Title: Accelerated TMS for Psychosis
Brief Title: Accelerated TMS for Psychosis
Brief Summary: This study is to determine the tolerability and efficacy of an accelerated schedule of
Transcranial Magnetic Stimulation for treating symptoms of psychotic disorders such as
schizophrenia.
For info regarding 2022P000689
please contact Roscoe Brady at 617-632-7933 or
robrady@bidmc.harvard.edu
Title: Cerebellar Modulation of Cognition in Psychosis
Brief Title: TMS Processing Speed
Brief Summary: The goal of this clinical trial is to learn about cognition in psychotic disorders
(schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it
aims to answer is: Can we use magnetic stimulation to change processing speed (how
quickly people can solve challenging tasks).
Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain
scans before and after transcranial magnetic stimulation (TMS). TMS is a way to
non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression
and obsessive compulsive disorder. In this study, we will use a different form of TMS to
temporarily change brain activity to observe how that changes speed in problem-solving.
For info regarding 2023C001134
please contact Roscoe Brady at 617-632-7933 or
robrady@bidmc.harvard.edu
Title: A Phase 1 Study of AGEN1181, an Fc-Engineered Anti–CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody in Subjects with Advanced Cancer
Brief Title: Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Brief Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety,
tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel
fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte
antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in
combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab),
and to assess the maximum tolerated dose (MTD) in participants with advanced solid
tumors. This study will also determine the recommended phase 2 dose (RP2D) of
botensilimab monotherapy and in combination with balstilimab.
For info regarding 19-132
please contact Phase I Oncology at 617-975-7452 or
PIO@bidmc.harvard.edu
Title: A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GP-2250 in Combination with Gemcitabine in Subjects with Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma Who Have Progressed on Prior Treatment with 5-Fluorouacil-based Chemotherapy
Brief Title: Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
Brief Summary: This is a phase 1 first in human, dose escalation trial of GP-2250 administered in
combination with gemcitabine in subjects with advanced pancreatic cancer previously
treated with 5-fluorouracil-based chemotherapy.
Prior radiosensitization with gemcitabine, the use of 5-fluorouracil, FOLFIRINOX or
Nab-paclitaxel/gemcitabine in the neoadjuvant setting, and prior pancreaticoduodenectomy
(Whipple procedure) is allowed. If prior treatment with gemcitabine was at therapeutic
doses, a minimum of 3 months must have elapsed since the end of such treatment.
As a precursor to 5-FU use of capecitabine-based chemotherapy is also permitted.
For info regarding 19-030
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Single Arm Phase 2 Study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic intrahepatic cholangiocarcinoma
Brief Title: Y-90 with Durvalumab/Gem/Cis in Intrahepatic Cholangio
Brief Summary: This trial is designed to study a combination of interventions (chemotherapy,
immunotherapy, and radiation) as a potential new treatment for bile duct cancer that
cannot be removed with surgery.
The specific names of the interventions that will be used are:
- Y-90 (a type of radiation microsphere bead)
- Durvalumab (a type of immunotherapy)
- Gemcitabine (a type of chemotherapy)
- Cisplatin (a type of chemotherapy)
For info regarding 21-541
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An open-label phase 1 study to investigate PF-08046050 (SGN-CEACAM5C) in adults with advanced solid tumors
Brief Title: A Study of PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors
Brief Summary: This clinical trial is studying advanced solid tumors. Solid tumors are cancers that
start in a part of your body like your lungs or liver instead of your blood. Once tumors
have grown bigger in one place but haven't spread, they're called locally advanced. If
your cancer has spread to other parts of your body, it's called metastatic. When a cancer
has gotten so big it can't easily be removed or has spread to other parts of the body, it
is called unresectable. These types of cancer are harder to treat.
Patients in this study must have cancer that has come back or did not get better with
treatment. Patients must have a solid tumor cancer that can't be treated with standard of
care drugs.
This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type
of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill
them. They may also stick to some normal cells.
This study will test the safety of PF-08046050 in participants with solid tumors that are
hard to treat or have spread throughout the body.
This study will have 3 parts. Part A and Part B of the study will find out how much
PF-08046050 should be given to participants. Part C will use the information from Parts A
and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers.
For info regarding 24-125
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Therapeutic Amyloid Reduction and Cortical Excitability in Alzheimers disease
Brief Title: TRACE-AD
Brief Summary: The purpose of this study is to understand how amyloid removal is beneficial to the brain in Alzheimers Disease. We hope this will help us improve future treatment options. We will enroll 40 Alzheimers disease participants who are planning to start lecanemab (an anti-amyloid agent) through BIDMCs clinical treatment program. TMS and EEG measures of cortical excitability will be assessed at Baseline and periodically over 18 months of treatment. This study will allow us to determine the extent to which the beneficial effects of amyloid removal on cognitive decline may be mediated through improvements in cortical excitablity. If you qualify for and take part in the study, you would undergo all study related visits and testing at no
charge. The study requires approximately 12 in-person visits. You will be compensated for your time and transportation will be provided for any in-person visits.
For info regarding 2024P000337
please contact Stephanie Buss at 617-975-8542 or
sbuss@bidmc.harvard.edu
Title: An open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy without first-line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura
Brief Title: Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura
Brief Summary: This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the
efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline
therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female
participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura
(iTTP).
The anticipated study duration per participant without a recurrence while on therapy is
maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment
for the presenting episode + 12 weeks of follow-up). Participants will have daily
assessments during hospitalization and weekly visits for assessments during ongoing
treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments
during the follow-up period. There will be two additional follow-up visits for
participants who do not have ADAMTS13 activity levels of =50% at the time of caplacizumab
discontinuation.
For info regarding 23-125
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Treatment In Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)
Brief Title: TITAN: SvS
Brief Summary: The ascending aorta conducts blood from the heart to the rest of the body. The ascending
aorta can become enlarged, and the risk of tearing and rupturing becomes higher with
larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if
surgery is done as soon as possible. Traditionally, when the ascending aorta gets above
5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based
relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture.
On the other hand, surgery carries its own risk as well. Since there are risk of waiting
or doing surgery, there is currently no great support for either approach for patients
with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between
5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will
undergo replacement of aorta, or the surveillance group, in which they will be closely
monitored. The chance of dying or suffer tearing or rupture of aorta between the two
groups will be compared. The result of the trial will guide future practice for patients
with enlarged ascending aorta.
This is a prospective, multi-centre randomized control trial that compares the all-cause
mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those
patients undergoing early elective ascending aortic surgery to those patients undergoing
surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion
criteria will be randomized to the early elective surgery group or the surveillance
group. Recruitment will end when the desired sample size is reached, and the patients
will be followed for a minimum 2-year period. The primary objective of the trial is to
compare the composite outcome of the all-cause mortality and incidence of acute aortic
events between surveillance and elective ascending aortic surgery for patients with
degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow
up. The hypothesis is that the early surgery group will have a significantly lower
all-cause mortality and incidence of acute aortic events at 2 years of follow up compare
to the surveillance group. The result of this trial will provide evidence based guidance
in the appropriate management of ascending aortic aneurysm based on the size criteria,
and establish a large database for future investigations.
For info regarding 2023P000361
please contact Brett Carroll at 617-123-4567 or
bcarrol2@bidmc.harvard.edu
Title: Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Cohort Study
Brief Title: Effectiveness of Open and Robotic Prostatectomy
Brief Summary: Prostate cancer is the most common cancer in American men. Surgical removal of the entire
prostate (prostatectomy) is one option among the various ways to treat prostate cancer.
The use of robot assistance for prostatectomy has become common place, but its
effectiveness has not been compared to standard open prostatectomy in trials carried out
at more than one medical institution in which participants are identified and followed
forward in time. Robot assisted and standard open prostatectomy health related quality of
life (HRQOL) outcomes have not been compared in a prospective, multi-centered study.
Prostatectomy can have side effects that can change with time. This research study seeks
to determine how common and how long-lasting such side effects are; to find out what
features of individual men's cancers and what features of the treatments affect those
side effects. This study also seeks to identify factors that affect the quality of
prostate cancer care by looking at how satisfied men are with their prostate cancer care.
Through these findings, this study aims to allow treatment side effects to be anticipated
more accurately for individual patients, and to provide a means for determining the
quality of prostate care.
For info regarding 10-155
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Randomized controlled trial assessing transperineal prostate biopsy to reduce infection complications
Brief Title: PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Brief Summary: Approximately one million transrectal prostate biopsies are performed annually in the
U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic
resistance of rectal flora. Preliminary data demonstrates that a transperineal
MRI-targeted biopsy approach under local anesthesia compared to the standard practice
transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable
pain/discomfort and may improve detection of prostate cancer.
This randomized controlled trial will be the first prospective study to evaluate
in-office transperineal MRI targeted prostate biopsy.
The investigators hypothesize that a transperineal MRI-targeted biopsy approach under
local anesthesia compared to the standard practice transrectal MRI-targeted prostate
biopsy has a much lower risk of infection, comparable pain/discomfort and may improve
detection of prostate cancer.
For info regarding 23-290
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Brief Title: LeAAPS Trial
Brief Summary: This trial is a prospective, randomized, multicenter, multinational, blinded, superiority
trial. The objective of this trial is to evaluate the effectiveness of left atrial
appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial
embolism in subjects undergoing cardiac surgery who have risk factors for atrial
fibrillation and ischemic stroke.
For info regarding 2023P000354
please contact Louis Chu at 617-667-7000 or
lchu@bidmc.harvard.edu
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Arenavirus-based Vector Therapy HB-502 and HB-501 in People with HIV on Suppressive Antiretroviral Treatment
Brief Title: see below
Brief Summary: This is a study of HB-502 and HB-501 alternating 2-vector therapy in people living with
human immunodeficiency virus (HIV) who are taking antiretroviral treatment (ART).
The benefits of available ART are short-lived and eventually there is a return of rapid
HIV replication and higher viral copy number after a period of initial improvement of
infection. The study treatment made of HB-502 and HB-501 is designed to train the body to
recognize and fight parts from substances found in HIV.
This trial studies the safety, tolerability, and ability of HB-502 and HB-501 to
stimulate an immune response against HIV in people living with HIV.
Participants will receive the study treatment by injection into the muscle every 8 weeks
for a duration of 24 weeks, which is followed by another 24 weeks to continue looking
closely at the safety profile and anti-HIV immune reaction after the last dose of study
treatment.
For info regarding 2024C000490
please contact Ai-ris Y Collier, MD at 617-735-4610 or
acollier@bidmc.harvard.edu
Title: COVID-19 and Other Respiratory Pathogens Biorepository
Brief Title: COVID-19 and Other Respiratory Pathogens Biorepository
Brief Summary: The purpose of this study is to establish a biorepository of specimens and clinical data from potential, confirmed, or convalescent Coronavirus disease 2019 (COVID-19) cases and from those vaccinated with a COVID-19 vaccine. The study recruits and enrolls special populations including individuals who are pregnant or lactating and who are receiving vaccines against COVID-19 infection.
For info regarding 2020P000361
please contact Ai-Ris Collier, MD at (617) 735-4610 or
CVVRtrials@bidmc.harvard.edu
Title: Infant Vaccine Biorepository
Brief Title: Infant Vaccine Biorepository
Brief Summary: The Infant Vaccine Biorepository is an observational study and the purpose is to better understand how long infant immune protection transferred through the placenta (from mother to baby) after maternal infection or vaccination lasts. We will research infections like influenza (the flu), pertussis (Whooping Cough), and SARS-CoV-2 (COVID-19), and others. You will be asked to collect a blood sample from your baby at home at 3-5 months-old, 6-8 months-old, and 9-12 months-old, using an investigational device for blood collection. The device will collect blood from the smallest blood vessels (the capillaries). The consenting parent will also have the option to test the device. Participation in this study will last until your baby is 1 year old. Compensation for participation is included.
For info regarding 2022P000765
please contact Dr. Ai-ris Collier at
CVVRtrials@bidmc.harvard.edu
Title: Measures of maternal immune function in fresh and stored blood samples
Brief Title: Immune response in fresh and stored blood
Brief Summary: This prospective cohort study seeks to determine whether immune function throughout pregnancy can be measured at the time of blood collection and also on blood that has been stored. The samples are analyzed using Treg assays on fresh peripheral blood samples and cytokine assays on stored plasma. Results will be compared to determine how measures of immune function from stored samples correlated to results from fresh samples. Participants must be pregnant with plans to deliver at BIDMC.
For info regarding 2021P000926
please contact Anna Modest, PhD MPH at
ammodest@bidmc.harvard.edu
Title: Miracle of life study: Observational study of pregnant women to validate biomarkers of pregnancy complication risk
Brief Title: MIRACLE of LIFE Study
Brief Summary: The primary objective of this study is to clinically verify and validate Mirvies cfRNA-based classifiers that predict the risk of a woman developing complications including preeclampsia, preterm birth, and gestational diabetes during her pregnancy. The putative classifiers were identified in a whole transcriptome discovery study of over 3,000 women completed in 2020. Subjects must be pregnant with a singleton pregnancy between 18-22 weeks gestation at time of enrollment to be eligible for this study.
For info regarding 2022P000224
please contact Eleanor Schonberg at 617-667-0881 or
pregnancystudy@bidmc.harvard.edu
Title: Mpox Tissue and Data Repository
Brief Title: Mpox Tissue and Data Repository
Brief Summary: The purpose of this study is to collect samples and clinical information for storage in a repository from individuals with a suspected or confirmed diagnosis of Monkeypox, individuals who recovered from Monkeypox, and individuals who received or plan to receive a vaccine against
Monkeypox.
For info regarding 2022P000577
please contact Center for Virology & Vaccine Research at 617-735-4610 or
CVVRtrials@bidmc.harvard.edu
Title: Randomized controlled trial of panniculus retraction methods for cesarean delivery
Brief Title: Panniculus retraction of cesarean delivery
Brief Summary: This prospective, open-label, randomized-controlled trial is designed to evaluate the use
of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device
will improve surgical outcomes, cardiopulmonary function, and provider/patient
satisfaction in morbidly obese women undergoing cesarean delivery.
For info regarding 2018P000369
please contact Ai-ris Collier at 617-667-7000 or
acollier@bidmc.harvard.edu
Title: Real-time assessment of breast cancer surgical specimen margins with nonlinear microscopy
Brief Title: Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
Brief Summary: This research is studying a new investigative imaging instrument called a nonlinear
microscope (NLM). A nonlinear microscope can produce images similar to an ordinary
pathologist's microscope, but without first processing tissue to make slides. This study
will determine if a NLM can be used to evaluate tissue during lumpectomy surgery for
breast cancer in order to reduce the probability that standard pathologic examination of
the specimen after the end of the operation will find close or positive margins, thus
possibly requiring the patient to have additional breast surgery.
For info regarding 16-145
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Trial of Combination Therapies with Adagrasib in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
Brief Title: Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Brief Summary: Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical
efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the
first-line setting for patients with advanced NSCLC with TPS = 1%, TPS <50% and KRAS G12C
mutation
For info regarding 23-318
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)
Brief Title: Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
Brief Summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan
(Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with
pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced
or metastatic non-squamous non-small cell lung cancer (NSCLC).
For info regarding 23-051
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus
Pembrolizumab vs Pembrolizumab Alone in
Treatment-naïve Subjects with Advanced or Metastatic
PD-L1 High (TPS =50%) Non-small Cell Lung Cancer
Without Actionable Genomic Alterations (Tropion-Lung08)
(Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in
the First-line Treatment of Subjects with Advanced or
Metastatic NSCLC Without Actionable Genomic
Alterations)
Brief Title: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
Brief Summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan
(Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants
with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.
For info regarding 22-296
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Brief Title: Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
Brief Summary: This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA
non-small cell lung cancer that has been or will be removed by surgery. Studying the
genes in a patient's tumor cells may help doctors select the best treatment for patients
that have certain genetic changes.
For info regarding 15-700
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations
Brief Title: A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of zipalertinib in
participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
harboring EGFR ex20ins mutations and other mutations.
For info regarding 24-186
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
Brief Title: A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
Brief Summary: DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd)
versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer
(NSCLC) with HER2 Exon 19 or 20 mutations
For info regarding 22-575
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO
Brief Title: Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-Small Cell Lung Cancer, ALCHEMIST Trial
Brief Summary: This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy
for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has
been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed,
carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop
the growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help
increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung
cancer.
For info regarding 20-379
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
Brief Title: A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of repotrectinib and
crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive
non-small cell lung cancer (NSCLC).
For info regarding 24-095
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Pilot Study Utilizing Transcranial Direct Current Stimulation (tDCS) during Sleep to Enhance Slow Waves and Cognitive Function in Schizophrenia
Brief Title: tDCS Stimulation during Sleep: Pilot Study
Brief Summary: The Center for Sleep and Cognition at Beth Israel Deaconess Medical Center (BIDMC) is seeking patients with a diagnosis of Schizophrenia and healthy control participants for a sleep study involving 3 afternoon nap sessions. The main purpose of this study is to explore whether transcranial electrical stimulation (tES), a device that introduces a weak electrical current to the brain, can enhance physiological markers of sleep. We will examine if tES can influence brain electrical activity (measured using electroencephalogram (EEG) patterns) during sleep, and we will also explore if these changes in sleep are related to performance on variety of cognitive tasks pre- and post-nap.
For info regarding 2022P000117
please contact Anthony Cunningham, PhD at 617-667-4702 or
acunnin4@bidmc.harvard.edu
Title: The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Brief Title: The Effect of Sleep Deprivation on Emotional Processing
Brief Summary: To further understand the impact of acute sleep deprivation and recovery sleep on the
processing of emotional information the investigators will address and attempt to answer
three questions, (i) how both undisturbed sleep and sleep deprivation affect the
processing and retrieval of emotional information, (ii) what neural and
psychophysiological mechanisms are associated with these behavioral effects, and (iii) to
explore the ability of recovery sleep to reverse the effects of sleep deprivation.
Together, these studies will provide a greater breadth and depth of knowledge concerning
sleep's role in emotion processing and regulation. Given the growing societal tendency to
view sleep as unproductive-foregoing it to lengthen work days and increase social
opportunities- such knowledge would be of practical importance for understanding the role
of sleep in healthy emotional functioning, particular for individuals experiencing
periods of increased stress and emotional distress (e.g., new parents, hospital staff, or
combat troops).
For info regarding 2019P000062
please contact Robert Stickgold at 617-632-7926 or
rstickgo@bidmc.harvard.edu
Title: The evolution of memories across wake and sleep
Brief Title: The evolution of memories across wake and sleep
Brief Summary: To further understanding of the relationship between sleep and memory the investigators
will address and attempt to answer three questions, (1) how memories evolve across wake
and sleep, (2) how different aspects of this memory evolution are reflected both
behaviorally and in the EEG signal, and (3) what stages and features of sleep affect
memory evolution. Together, these studies will provide a greater breadth and depth of
knowledge concerning sleep's role in memory consolidation. Such knowledge would be of
practical importance for educational practices, whether in schools, on the job, or in the
military, and would also provide valuable information to the fields of sleep medicine and
psychiatry, where interactions between sleep disorders and cognitive functioning are of
great importance.
For info regarding 2016P000222
please contact Anthony Cunningham, PhD at 617-667-4702 or
acunnin4@bidmc.harvard.edu
Title: The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
Brief Title: The Effect of Sleep Loss on Emotion
Brief Summary: The study is designed to investigate the impact of three nights of sleep restricted to 4
hours per night, on the processing and regulation of emotional information compared to
Insomnia Disorder and control. The investigators will address and attempt to answer two
questions.
(i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the
processing and regulation of emotional information compared to typical, undisturbed
sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated
with behavioral effects when attempting to process and regulate emotions in a sleep
restricted state or with a clinical diagnosis of Insomnia Disorder? This study will
investigate sleep's role in emotion processing and regulation. The findings will help
further understanding of the role of sleep in healthy emotional functioning.
For info regarding 2022P000120
please contact Anthony Cunningham, PhD at (617)667-4702 or
acunnin4@bidmc.harvard.edu
Title: The Liver Incytes System, evaluation of liver fibrosis and steatosis versus MRE and MRI-PDFF SI-CLIN-02
Brief Title: Fibroscan Study
Brief Summary: Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in
healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory
ability of elasticity measurements generated by Liver Incyte for healthy volunteers
versus patients with liver fibrosis in comparison to FibroScan measurements.
For info regarding 2018P000730
please contact Liver Center Trials Office at 617-632-1118 or
mcurry@bidmc.harvard.edu
Title: Measurement of interstitial fluid analytes using noninvasive Cambridge Medical Technologies biosensor
Brief Title: CMT biosensor
Brief Summary: In this study, we will learn how well a new device made by Cambridge Medical Technologies (CMT), called the CMT biosensor, is able to measure the amount of glucose and lactate in your body. The current way of measuring these substances is by drawing blood. The downside of blood draws is that they can cause discomfort, increased risk of infection, damage to blood vessels, and delay in measurement. The CMT biosensor uses a new way to sample fluid from your body without the pain associated with a blood draw using a gentle (painless) electrical pulse. The data we get from this study will be used to see how well the CMT biosensor works compared to standard blood draw testing and improve it, so one day, it can be used without the need to draw blood.
For info regarding 2024P000674
please contact Carlo Ottanelli at 617-650-0042 or
cottanel@bidmc.harvard.edu
Title: Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor
Brief Title: Octaplex
Brief Summary: This is a multicentre, prospective, randomised, double-blinded, group-sequential,
parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy
and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with
acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be
randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.
For info regarding 2022P000471
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: Sleep for Stroke Management And Recovery Trial
Brief Title: SleepSMART
Brief Summary: The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes at 3 months in patients who experienced an
ischemic stroke.
For info regarding 2019C000228
please contact Sarah Marchina at
smarchin@bidmc.harvard.edu
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study toDetermine the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for StrokePrevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-LIBREXIA-STROKE (Sponsor protocol 70033093STR3001)
Brief Title: LIBREXIA Stroke
Brief Summary: The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke.
For info regarding 2024P000117
please contact Jennifer Dearborn-Tomazos at 617-667-1803 or
jtomazos@bidmc.harvard.edu
Title: A Phase 2/3 Adaptive, Double-blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adults and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease
Brief Title: Phase 2/3 Adaptive Study of VX-147 in Adults With APOL1-medi
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease.
For info regarding 2022P000526
please contact Liz Roy at (617) 975-8684 or
eroy2@bidmc.harvard.edu
Title: Mind Body Intervention for Chronic Upper Extremity Pain
Brief Title: PSRT for CUEP
Brief Summary: We are recruiting for a research study to test a mind-body approach to reduce or eliminate chronic upper extremity pain and improve the quality of life for people suffering from chronic upper extremity pain and who do not respond well to pharmacological (medicine) or surgical interventions
For info regarding 2023P000579
please contact Mind Body Study Team at 617-754-2882 or
mindbodystudy@bidmc.harvard.edu
Title: A Phase 2 Multicohort Study of Nivolumab in Combination with Docetaxel and Androgen Deprivation Therapy in Metastatic Hormone Sensitive Prostate Cancer Patients with DNA Damage Repair Defects or Inflamed Tumors
Brief Title: Nivolumab + Docetaxel + ADT in MHSPC Patients with DDRD or Inflamed Tumors
Brief Summary: This research study is studying a combination of hormonal therapy, chemotherapy, and
immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer.
The names of the study drugs involved in this study are:
- Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may
include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon).
- Docetaxel
- Nivolumab
For info regarding 19-384
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (ARCITECT)
Brief Title: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Brief Summary: This study is a randomized, open label, multicenter Phase II trial to evaluate the
efficacy and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and
balstilimab (a novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve
patients with metastatic ccRCC. The study will plan to enroll 120 eligible patients
randomized in a 2:1 fashion to Arm A and Arm B. Patients in all IMDC Risk Groups are
included. This study utilizes a Simon's two stage design which is described in the
protocol. Patients randomized to Arm A will receive botensilimab in combination with
balstilimab. Patients randomized to Arm B will receive ipilimumab in combination with
nivolumab. Study treatment on both arms will continue until toxicity, disease progression
or a maximum of 96 total weeks (12 weeks induction, 84 weeks maintenance).
For info regarding 23-551
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: LuCarbo – a phase 1a/1b study of 177Lu-PSMA-617 plus carboplatin in metastatic castrate-resistant prostate cancer.
Brief Title: LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer
Brief Summary: The purpose of this study is to see whether the combination of a chemotherapy drug,
carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating
prostate cancer and whether the combination is effective in shrinking or preventing
growth of prostate cancer.
The names of the study drugs used in this research study are:
- Carboplatin (A type of chemotherapy)
- 177Lu-PSMA-617 (A type of radioligand therapy)
For info regarding 23-693
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Understanding the Interaction between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Brief Title: Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Brief Summary: The goal of this research study is to determine whether hormonal therapies used early in
the course of prostate cancer could increase the amount of Prostate-Specific Membrane
Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate
cancer. This study will measure PSMA levels using standard PET/CT scans and participants
will receive standard-of-care androgen receptor antagonist monotherapy.
The names of the treatment interventions involved in this study are:
- Androgen receptor antagonist monotherapy.
- PSMA PET/CT scan
It is expected that about 15 people will take part in this research study.
Participation in this research study is expected to last about 4 weeks.
For info regarding 22-441
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Prospective, Multicenter, Single- Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae (Lutonix AV PAS)
Brief Title: Lutonix AV PAS
Brief Summary: This prospective, global, multicenter, single arm post-approval study is designed to
investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB)
PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native
arteriovenous (AV) fistulae located in the upper extremity.
For info regarding 2022P000866
please contact Salomao Faintuch at 617-754-2523 or
sfaintuc@bidmc.harvard.edu
Title: A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Brief Title: ENGULF
Brief Summary: Evaluation of initial safety and clinical feasibility of the Helo PE Thrombectomy System
for thrombectomy in acute submassive pulmonary embolism (PE).
For info regarding 2023P000008
please contact Salomao Faintuch at 617-754-2523 or
sfaintuc@bidmc.harvard.edu
Title: Feasibility of the comfort measures only time out (CMOT) to reduce distress during Palliative Withdrawal of Mechanical Ventilation
Brief Title: Feasibility of comfort measures only time out (CMOT)
Brief Summary: Nearly 25% of Americans die in intensive care units (ICUs). Most deaths in ICUs are
expected and involve the removal of ventilator support, or palliative withdrawal of
mechanical ventilation (WMV). Prior work by the Principal Investigator (PI) found that
patient suffering can be common; with 30-59% of patients going through this process
experiencing distress. Thus, experts and national organizations have called for evidence
to inform guidelines for WMV. This research study will 1) develop and refine a Comfort
Measures Only Time out (CMOT) intervention consisting of a structured time out with
check-list protocol for the ICU team (nurse, physician, respiratory therapist) to improve
the process of WMV. and 2) Pilot test the CMOT intervention in 4 ICUs (2 medical/2
surgical) among 40 WMV patients.
For info regarding 2023P000160
please contact Corey Fehnel at 617-667-7000 or
cfehnel@bidmc.harvard.edu
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
Brief Title: DaeWoong DWN12088
Brief Summary: This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate
the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
For info regarding 2023P000113
please contact Clinical Research Center at 617-975-7600 or
crc@bidmc.harvard.edu
Title: A Prospective Registry Study in a Global Huntingtons Disease Cohort
Brief Title: A Prospective Registry Study in a Global Huntingtons Diseas
Brief Summary: Enroll-HD is a longitudinal, observational, multinational study that integrates two
former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North
America and Australasia-while also expanding to include sites in Latin America. More than
30,000 participants have now enrolled into the study. With annual assessments and no end
date, Enroll-HD has built a large and rich database of longitudinal clinical data and
biospecimens that form the basis for studies developing tools and biomarkers for
progression and prognosis, identifying clinically-relevant phenotypic characteristics,
and establishing clearly defined endpoints for interventional studies. Periodic cuts of
the database are now available to any interested researcher to use in their research -
visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
For info regarding 2018P000332
please contact Samuel Frank at 617-667-4889 or
sfrank2@bidmc.harvard.edu
Title: The Functional Neuroanatomy of the Human Physiological Stress Response
Brief Title: Functional Neuroanatomy of Physiological Stress
Brief Summary: The purpose of this study is to examine the effect of a moderately low blood sugar stress
on the nervous system. The investigators hope that information obtained from completing
this study will help to reveal information about how a non-psychological stress impacts
the parts of the brain that react to stress and the autonomic nervous system. The
autonomic nervous system is the part of the nervous system that provides the body with
involuntary or automatic control of heart rate, blood pressure, and breathing.
For info regarding 2019C000177
please contact Roy Freeman at 617-632-8454 or
rfreeman@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Efficacy And Safety Of Rifaximin Soluble Solid Dispersion (Ssd) Tablets For The Delay Of Encephalopathy Decompensation In Cirrhosis (Red-C) Rnlc3131
Brief Title: RED-C
Brief Summary: Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter
study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the
first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis,
defined by the presence of medically controlled ascites.
For info regarding 2023P000408
please contact Zachary Fricker at
zfricker@bidmc.harvard.edu
Title: A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients with Hepatorenal Syndrome– Acute Kidney Injury
Brief Title: River 2 Renal
Brief Summary: This study aims to evaluate the safety, tolerability and efficacy of R2R01 combined with
terlipressin as compared to terlipressin alone in the treatment of patients with HRS-AKI
For info regarding 2023P000456
please contact Zachary Fricker at
zfricker@bidmc.harvard.edu
Title: Brain Plasticity in Cognitive Aging
Brief Title: Plasticity in cognitive aging
Brief Summary: The overall goal of this research is to learn more about changes in the structure and physiology (function) of the brain that occur as people age and how these changes relate to cognition (thinking) and other markers of brain health. You are invited to take part in this research study if you are in good overall health and you have not been diagnosed with mild cognitive impairment or dementia. The study includes 4 in-person research visits,
to be completed in about 6 weeks.
For info regarding 2020P000889
please contact Christie Morse at (617)667-8412 or
cmorse2@bidmc.harvard.edu
Title: Brain Plasticity in Type-2 Diabetes
Brief Title: Brain Plasticity in Type-2 Diabetes
Brief Summary: The overall goal of this research is to learn more about changes in the structure and physiology (function) of the brain that occur in people with diabetes as they get older and how these changes relate to cognition (thinking) and other markers of brain health. By comparing the results from the diabetes groups with people who do not have diabetes, we hope to increase our understanding of why some people with diabetes develop problems with their cognition as they get older and have a higher risk of developing Alzheimers disease. You are invited to take part in this research study if you have type-2 diabetes or are in good overall health and you have not been diagnosed with mild cognitive impairment or dementia. The study includes about 6 in-person research visits, to be completed in about 8-10 weeks.
For info regarding 2020P001152
please contact Andrew Northrop at (617)667-0271 or
anorthro@bidmc.harvard.edu
Title: Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
Brief Title: Family-Focused Therapy for Individuals at High Clinical Ris
Brief Summary: This study is being conducted by researchers from UCLA, BIDMC, and 5 other research sites to compare two different kinds of therapy for teenagers and young adults (ages 12-25) who may have experienced changes in their thinking or mood. The study seeks to determine whether family and individual counseling sessions help people to feel better and function better in school, work, and in relationships. It involves a full mental health evaluation, including diagnostic impressions and feedback, 6 months of one type of treatment for participant and involving their family members, and follow-up wellness/research check-ups for 18 months.
For info regarding 2020C000558
please contact Colette Potts at 617-754-1209 or
ResponsetoRisk@bidmc.harvard.edu
Title: Individualized Vocational and Educational Support and Training for Clinical High Risk for Psychosis (InVEST)
Brief Title: Individualized Vocational and Education Support and Training
Brief Summary: The purpose of this study is to test the efficacy of InVEST (Individualized Vocational
and Educational Support and Training) for CHR-P (clinical high risk for psychosis) to
address specific role functioning difficulties associated with the CHR-P phase. Our
specific goals are:
1. Part 1: Preliminary open trial of InVEST (n = 8) to collect preliminary feasibility
and acceptability data by providing the intervention, administering assessments, and
collecting focus group and self-report feedback from open trial participants. The
open trial phase will help to refine recruitment approaches and to modify the
treatment manual as needed.
2. Part 2: Preliminary randomized controlled trial of InVEST vs. Delayed InVEST (DI) to
explore preliminary evidence of efficacy of InVEST vs. DI (n = 30). The
investigators hope to gain understanding of the feasibility of InVEST and the
study's assessment procedures, and to gain a preliminary understanding of the
intervention's efficacy for functioning difficulties experienced by young people at
CHR-P.
For info regarding 2021P000689
please contact Colette Potts at 617-754-1209 or
ResponsetoRisk@bidmc.harvard.edu
Title: LEADER Neoadjuvant Screening Trial; LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer
Brief Title: Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers
Brief Summary: This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium
(LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to
determine the feasibility of comprehensive molecular profiling to detect actionable
oncogenic drivers in patients with suspected early stage lung cancers scheduled to
undergo biopsies to establish the diagnosis of lung cancer.
The primary purpose of this testing is to determine the presence of 12 oncogenic drivers
(mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK,
RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can
serve as targets making patients eligible for upcoming targeted neoadjuvant therapy
trials. The ultimate goal is to use this information from the screening process to select
the optimal neoadjuvant therapy and wherever possible enroll patients onto separate
neoadjuvant therapy trials with genomically matched treatments or other appropriate
trials if no actionable driver mutation is detected.
Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American
Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through
administration of multi-site trials focused on recent advances in lung cancer. TSOG has
aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's
involvement will be essential in trial enrollment and ultimate interpretation of the
multimodal clinical and translational data collected as part of this study. We estimate
we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of
patients will represent a cohort identified by their care teams as candidates for other
potential neoadjuvant therapies which may include checkpoint inhibitors such as
atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents.
The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER
screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are
detected, the patient will be offered participation in any clinical trial of neoadjuvant
therapy available at their treating institution or standard of care therapy. For patients
not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will
be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment
but before surgery, and after surgery. This initiative will be correlated with various
clinical outcomes. Prespecified clinical data will be collected for correlation with
these circulating biomarkers.
For info regarding 21-543
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Brief Title: Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Brief Summary: A postoperative autologous blood patch (ABP) intervention trial for patients who
underwent lung resection for cancer to examine its effectiveness in preventing a
prolonged air leak.
AIM 1: To determine the safety and efficacy of autologous blood patch (ABP) as a means to
reduce the rate of prolonged air leak (PAL) after lung cancer resection
AIM 2: To prospectively examine variation in morbidity and quality of life between
patients with and without a PAL
For info regarding 22-426
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A 2-stage, Lead-in and Randomized, Phase 2, Openlabel study of Darolutamide versus Enzalutamide as Monotherapy on Testosterone Levels Change in Men with Hormone-Naïve Prostate Cancer (ARAMON)
Brief Title: A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide
Brief Summary: Researchers are looking for a better way to treat men who have biochemically recurrent
hormone-naïve prostate cancer.
Hormone-naïve prostate cancer is a prostate cancer that has not yet been treated with
hormonal therapy including androgen deprivation therapy (ADT). Biochemically recurrence
(BCR) means that patients who received local treatment (surgery or radiation therapy) for
prostate cancer now present with a rise in the blood level of a specific protein called
PSA (prostate-specific antigen) but no detectable cancer or cancer spreading after a
treatment that aimed to cure their prostate cancer (e.g. surgery and radiation). This may
mean that the cancer has come back as the PSA level can be taken as a marker for prostate
cancer development. Although men with BCR may not have symptoms for many years, proper
treatment for BCR is important as the cancer may spread to other parts of the body in 7-8
years.
In prostate cancer patients, male sex hormones like testosterone (also called androgens)
can sometimes help the cancer spread and grow. To reduce androgen levels in these
patients, androgen deprivation therapy (ADT) is often used.
Second generation androgen receptor inhibitors including Darolutamide and Enzalutamide
are available for the treatment of prostate cancer in addition to ADT. These inhibitors
work by blocking androgen receptors and preventing it from attaching to proteins in
cancer cells in the prostate. It is already known that men with prostate cancer benefit
from these treatments. But besides benefits, Darolutamide and Enzalutamide are not
without side effects.
Clinical studies have shown that treatment with Enzalutamide increase testosterone level
in serum, probably because it can pass blood brain barrier and goes into the central
nervous system (CNS). The increased testosterone levels are thought to cause some
specific side effects including so called feminizing side effects like overdevelopment of
the breast tissue in men, and breast tenderness. Darolutamide has a distinct chemical
structure and reduced ability to enter the CNS compared with Enzalutamide. That means
that Darolutamide potentially leads to fewer and less severe side effects than
Enzalutamide.
In this study researchers will collect more data to learn to what extent Darolutamide
affects serum testosterone levels in men with BCR in hormone-naïve prostate cancer. This
study will consist of 2 stages. In stage 1 (also called lead-in phase) all participants
will take Darolutamide by mouth twice a day. The study team will monitor and measure
testosterone levels in the blood after:
- 12 weeks
- 24 weeks and
- 52 weeks of treatment.
The second stage (also called randomized phase) is conditional and depends on the results
from the stage 1. It will be conducted if after 24 weeks of treatment with Darolutamide
in stage 1:
- a mean change in blood testosterone levels is below 45% and
- if the feminizing side effects (including overdevelopment of the breast tissue in
men, and breast tenderness) will occur less frequently than previously reported.
In the second stage of this study all participants will be randomly (by chance) assigned
into two treatment groups, taking either Darolutamide twice daily or Enzalutamide once
daily by mouth for a minimum of 12 and a maximum of 52 weeks.
During both stages of this study the study team will:
- do physical examinations
- take blood and urine samples
- examine heart health using ECG
- examine heart and lung health using CPET
- check bone density using x-ray scan (DEXA)
- check vital signs
- check if the participants' cancer has grown and/or spread using CT (computed
tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
- ask the participants questions about how they are feeling and what adverse events
they are having.
An adverse event is any medical problem that a participant has during a study. Doctors
keep track of all adverse events that happen in studies, even if they do not think the
adverse events might be related to the study treatments.
The study participants who receive Darolutamide in stage 2 can continue to receive their
treatments as long as they benefit from the treatment. The participants from the
Enzalutamide group can also switch to treatment with Darolutamide after finishing stage
2. The study team will continue to check the participants' health and collect information
about medical problems that might be related to Darolutamide until up to 30 days of last
dose for those participants who continue on treatment with Darolutamide.
For info regarding 22-386
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
Brief Title: The CORCINCH-HF Study
Brief Summary: Prospective, randomized, open-label, international, multi-center clinical study to
evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in
patients with heart failure and reduced ejection fraction (HFrEF).
For info regarding 2020P000833
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
Brief Title: What the Nose Knows
Brief Summary: This project proposes to conduct the first study of the predictive utility of olfactory
hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The
information gathered from the project is of considerable public health relevance, in
that, through simple, reliable olfactory assessment, it will provide knowledge about
which individuals are most likely to benefit from these psychosocial interventions. Such
information is crucial for tailoring existing interventions and developing new approaches
to optimize outcomes in schizophrenia.
For info regarding 2022P000199
please contact Sunny Lee at 617-754-1203 or
slee54@bidmc.harvard.edu
Title: Brown Adipose Tissue Function in Adults with Hypothyroidism and with Hyperthyroidism
Brief Title: Brown Adipose Tissue Function in Adults with Hypothyroidism
For info regarding 2023P000830
please contact Alina Gavrila, MD at 617-667-9344 or
agavrila@bidmc.harvard.edu
Title: A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer.
Brief Title: A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Brief Summary: This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment,
dose escalation and expansion study designed to determine the safety and tolerability of
STM-416 in patients with bladder cancer.
For info regarding 23-164
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Brief Title: A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Brief Summary: This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT
followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the
treatment of participants with IR-NMIBC.
For info regarding 24-247
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Blue Light Cystoscopy With Cysview® (BLC™ with Cysview®) Registry
Brief Title: Blue Light Cystoscopy With Cysview® Registry
Brief Summary: Registry study to gather more information on the current use of Blue Light Cystoscopy
with Cysview (BLCC) in urologists' practices.
For info regarding 22-484
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Prospective validation of electronic seizure diary forecasting
Brief Title: Prospective validation of electronic seizure diary forecasti
Brief Summary: This study hopes to be able to find a method to forecast, or predict, when seizures will happen in those with temporal lobe epilepsy. This would allow someone to take the necessary precautions in order to alleviate, or even prevent, a seizure event. This is a virtual study, and participants will be using a website and an app to track their seizures and medications. Participation is approximately 10 months.
For info regarding 2022P000548
please contact Daniel Goldenholz at 617-632-8930 or
EpilepsyPlusDataScience@bidmc.harvard.edu
Title: Video-Assisted Frailty Measurement in the Emergency Department
Brief Title: Frailty
Brief Summary: A prospective, observational cohort study of a convenience sample of adults aged 65 or older who present to the
Beth Israel Deaconess Medical Center ED. This study will help us determine whether a video recording taken in
the emergency department accurately measures frailty.
For info regarding 2023P000306
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
Brief Title: Optimizing Family Counseling for Preterm Delivery
Brief Summary: Antenatal family counseling for anticipated extremely preterm deliveries remains
ethically and practically challenging for maternal-fetal medicine specialists and
neonatologists alike. The overall goal of this project is to improve antenatal counseling
and counseling outcomes for families facing anticipated extremely preterm delivery
through innovative, interdisciplinary simulation-based education for maternal fetal
medicine specialists and neonatologists, using language preferred by families, and
focusing on eliciting values and building partnerships through advanced communication and
relational skills.
For info regarding 2019C000598
please contact NICU Research Team at 617-355-7260 or
NICUResearch@bidmc.harvard.edu
Title: Comparison of Continuous Non-Invasive Arterial Blood Pressure to Invasive Arterial Blood Pressure Measurement in Pregnant Women with Placenta Accreta
Brief Title: CNAP vs IABP in pregnant women with placenta accreta
Brief Summary: The objective of this study is to investigate a technique to monitor blood pressure in
women undergoing cesarean delivery with suspected placenta accreta spectrum. To achieve
this objective, the investigators plan to conduct a prospective, observational study with
the following aims:
Specific Aim 1: Compare concordance between the systolic (SBP), diastolic (DBP), and mean
arterial blood pressure (MAP) readings from the continuous non-invasive arterial blood
pressure (CNAP) and IABP at several discrete points throughout the procedure
Specific Aim 2: Determine the feasibility of using CNAP to aid in decision making by
examining the parameters of volume responsiveness and arterial elastance at several
discrete points throughout the procedure.
The investigators hypothesize that the investigators can obtain similar blood pressure
monitoring using CNAP as compared to the gold standard IABP in women undergoing cesarean
delivery with suspected placenta accreta.
For info regarding 2020P001099
please contact John Kowalczyk at 617-667-3112 or
jkowalcz@bidmc.harvard.edu
Title: Examining the gastric emptying halftime of water versus a carbohydrate in early labor
Brief Title: Gastric emptying in labor
Brief Summary: To determine the half time of the emptying of the stomach of women in early labor with
and without epidural pain relief when drinking either water or a carbohydrate-based
sports drink.
For info regarding 2019P001110
please contact Philip Hess at 617-667-3112 or
phess@bidmc.harvard.edu
Title: INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT)
Brief Title: INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Brief Summary: This research study is studying several investigational drugs as a possible treatment for
Glioblastoma (GBM).
The drugs involved in this study are :
- Abemaciclib
- Temozolomide (temodar)
- Neratinib
- CC115
- QBS10072S
For info regarding 16-443
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Cardiometabolic disease and heart failure with preserved ejection fraction
Brief Title: BI HFpEF
Brief Summary: This is a prospective observational study of 250 patients receiving care at BIDMC who have heart failure with preserved ejection fraction (HFpEF). The aim of the study is to better understand the link between cardiometabolic disease and HFpEF. At each visit, we will conduct a physical exam and perform a blood draw, and participants will complete a health questionnaire to assess quality of life. There will be up to 3 study visits over the course of 3 months. About 1 year after enrollment, participants will be re-contacted for a telephone health survey.
For info regarding 2023P000392
please contact Ndidi Owunna at 617-735-4126 or
nowunna@bidmc.harvard.edu
Title: Long-Term Endothelial Effects of COVID-19 in Obesity
Brief Title: Long-Term Endothelial Effects of COVID-19 in Obesity
Brief Summary: The CLEO study examines the long-term effects of COVID-19 infection and whether these effects are different in people who have obesity compared to people who do not have obesity. Participation in the study will involve a physical exam, IV placement with blood sampling, cell collection from a vein, ultrasound, and cardiac PET adn will take approximate 1 to 4 study visits over 1 to 6 months at BIDMC and Brigham and Womens Hospital BWH).
For info regarding 2021P001066
please contact Ndidi Owunna/Abbey Pan at 617-735-4124 or
CLEO@bidmc.harvard.edu
Title: Feasibility Study of B-Mode and Ultrasound Elastography ARFI Technology for Surface Lung Tissue Evaluation of Patients with normal and diseased lung, including COVID-19 Pneumonia
Brief Title: Ultrasound Elastography
Brief Summary: The main purpose of this study is to test Whether ultrasound elastography measurements can determine if a patient has 1. Normal lung tissue, or 2. Water in their lungs, as in patients with heart failur. 3. Pneumonia without COVID-19, or 4. Pneumonia due to COVID-19.
For info regarding 2021P000331
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: Capnography for COPD/CHF Differentiation and for Early Diagnosis of Asthma
Brief Title: Capnography for COPD/CHF Differentiation
Brief Summary: We are conducting this study to learn more about whether measuring carbon dioxide levels in your breath will help us determine whether you have COPD or CHF or if you have asthma, how severe your asthma attack is and how you are responding to treatment.
For info regarding 2019P001036
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: A Safety, Immunogenicity and Efficacy Phase 1/2a Study of a Heterologous Ad26Mos4HIV, MVA-BN-HIV Vaccine Regimen Plus Broadly Neutralizing Antibodies PGT121, PGDM1400 and VRC07-523LS in HIV-1 Infected Adults on Suppressive ART
Brief Title: HTX1004
Brief Summary: A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a
clinical study to investigate the safety, tolerability, immunogenicity and exploratory
efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with
Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies
(bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1
(HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).
For info regarding 2021P000538
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: Effects of DASH Groceries on Blood Pressure in Black Residents of Urban Food Deserts With Treated Hypertension (GoFreshRx)
Brief Title: Groceries for Black Residents of Boston to Stop Hypertension
Brief Summary: GoFreshRx is a randomized trial, testing the effects of a home-delivered DASH-patterned
grocery intervention on blood pressure in Black adults actively treated for hypertension,
residing in Boston area urban food deserts.
For info regarding 2022P000221
please contact Stephen Juraschek at 617-754-1416 or
sjurasch@bidmc.harvard.edu
Title: Effects of DASH Groceries on Blood Pressure in Black Residents of Urban Food Deserts Without Treated Hypertension
Brief Title: Groceries for Black Residents of Boston to Stop Hypertension
Brief Summary: GoFresh is a randomized trial, testing the effects of a home-delivered DASH-patterned
grocery intervention on blood pressure in Black adults, residing in Boston area urban
food deserts.
For info regarding 2021P000825
please contact Stephen Juraschek, MD PhD at 617-903-7943 or
gofresh@bidmc.org
Title: Wearable Evaluation of Ambulatory Readings for Blood Pressure
Brief Title: WEAR - BP
Brief Summary: The aim of this project is to serve as a quality control measure, assessing the accuracy and reliability of novel cuffless Blood Pressure monitoring devices. These devices will be evaluated in comparison to the established standard, Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device. This assessment is crucial to ensure the trustworthiness and suitability of the new devices for upcoming research projects. Up to 250 participants (at least 100) will be involved in this study each wearing up to 7 devices (6 BP and 1 activity monitor). The assignment of devices will be randomized by day and by the arm or wrist on which they are worn.
For info regarding 2024P000441
please contact Frederick Labri Kwapong at
flarbitw@bidmc.harvard.edu
Title: Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry
Brief Title: N/A
Brief Summary: OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval
registry.
For info regarding 2023P000774
please contact Masashi Kai at
mkai1@bidmc.harvard.edu
Title: A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Brief Title: A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Brief Summary: CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very
accurately to a tumor. The ability of this technology to minimize radiation dose to
organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus
potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is
commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized
prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for
the treatment of clinically localized primary renal cell carcinoma.
For info regarding 12-235
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion
Brief Title: Occluflex Study
Brief Summary: The objective of this study is to investigate whether percutaneous PFO closure with the
Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore®
Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke,
and device/procedure related Serious Adverse Events (SAE).
For info regarding 2024P000327
please contact clifford kavinsky at
cjkavins@bidmc.harvard.edu
Title: CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS
Brief Title: CERBERUS
Brief Summary: The goal of this observational study is to learn the how to determine the mean arterial
pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for
optimal brain health in patients above the age of 60 undergoing major non-cardiac
surgery. The main question[s] it aims to answer are:
- Is there a way to tailor the blood pressure to be maintained in such patients during
surgery for optimal brain health using non-invasive monitors that check the brains
electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood
oxygen levels, the cerebral oximetry(CO) monitor?
- How much does this optimal blood pressure level vary between patients?
Participants will be asked to:
- Complete a questionnaire at the time they enroll into the study, as well as a daily
questionnaire to help determine their level of thinking and brain health. This
questionnaire will be administered by a member of the study team.
- They will also have an EEG and CO monitoring sticker placed on their foreheads. This
will be connected to a monitor that will collect this data just before, during, and
after their surgery. The data collected through these monitors will help us with our
study goals.
For info regarding 2023P000843
please contact Samir Kendale at
skendale@bidmc.harvard.edu
Title: Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
Brief Title: BICEPS
Brief Summary: We are conducting this study to learn more about the onset of psychosis and psychotic disorders including
Schizophrenia, Schizoaffective Disorder, Schizophreniform, and Bipolar I Disorder. We are hoping to examine
characteristics of these disorders and learn more about how different people with these disorders might have
different outcomes over time. We will be doing this with a variety of study assessments including clinical
interviews, an MRI, EEG, eye-tracking task, and paper and pencil/computerized tasks. All of these are standard
tools used in studies in this field.
For info regarding 2022P000622
please contact Lola Nedic at 617-863-0886 or
lnedic@bidmc.harvard.edu
Title: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants with Moderate to Severe Hidradenitis Suppurativa
Brief Title: Evaluate Eltrekibart in Adults with Hidradenitis Suppurativa
Brief Summary: This study aims to find the appropriately safe and effective dose and dosing frequency
for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for
further clinical development. The study will last approximately 62 weeks and may include
up to 31 visits.
For info regarding 2024P000158
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa
Brief Title: Evaluate sonelokimab in adults with hidradenitis suppurativa
Brief Summary: This is a study to evaluate the clinical efficacy and safety of sonelokimab administered
subcutaneously compared with placebo in the treatment of adult participants with moderate
to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either
sonelokimab or matching placebo up to Week 16.
For info regarding 2024P000641
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy andSafety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe HidradenitisSuppurativa Who Have Failed Anti-TNF Therapy
Brief Title: Abbvie M23-698: Evaluation of Upadacitinib in HS Adults
Brief Summary: Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions
in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This
study will assess how safe and effective upadacitinib is in treating adult and adolescent
participants with moderate to severe HS who have failed to respond to or are intolerant
of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease
activity will be assessed.
Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid
arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the
treatment of HS. This study is "double-blinded", meaning that neither the trial
participants nor the study doctors will know who will be given upadacitinib and who will
be given placebo. This study is comprised of 3 periods. In Period 1, participants are
randomized into 2 groups called treatment arms where each group receives a different
treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In
Period 2, participants are placed into 6 different groups depending on their placement
and results in Period 1. Period 3 is the long-term extension period where participants
will continue treatment from Period 2. Approximately 1328 adult and adolescent
participants diagnosed with HS will be enrolled in approximately 275 sites worldwide.
Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks
in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter
Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks.
Participants will be followed up for approximately 30 days.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular outpatient visits during the study.
The effect of the treatment will be checked by medical assessments, checking for side
effects and completing questionnaires.
For info regarding 2023P000553
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A pilot study evaluating the safety and efficacy of deucravacitinib compared to placebo in the treatment of moderate-to-severe Hidradenitis suppurativa (HS)
Brief Title: Evaluating deucravacitinib in the treatment of HS
Brief Summary: The study is a randomized, proof of concept study. 30 patients aged 18 and over with HS
will be included in this single center, randomized, double-blind, parallel-group study.
Dosage of deucravacitinib will be given according to the investigational regimen as
follows: 6 mg po bid for 16 weeks. The study compromises a 4-week screening period, a
16-week study period, and a 4-week follow-up period. The follow-up period consists of a
follow-up phone call 4 weeks after the last study drug dose.
For info regarding 2023P000400
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Understanding components of mind-body exercise for physical activity engagement in metabolic syndrome: Pilot RCT
Brief Title: Mind-body exercise for physical activity
Brief Summary: The aim of this study is to assess the feasibility and acceptability (e.g., enrollment,
adherence, retention, acceptability of procedures and interventions) of a pilot factorial
study design that will help elucidate components of mind-body exercise interventions. The
study involves completing a walking program, a mindful attention program, a walking
program that includes mindful attention, or no program at all. A "pilot" study is a
smaller study that helps researchers to understand whether the study design can be
carried out and what participants think about the study.
For info regarding 2022P000037
please contact Kristen Kraemer at 617-754-1465 or
kkraemer@bidmc.harvard.edu
Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants with Uncontrolled Hypertension on Two or More Medications including Participants with Resistant Hypertension
Brief Title: Baxdrostat
Brief Summary: This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled,
parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg
baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of
systolic blood pressure in approximately 720 participants aged = 18 years with
hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of
which is a diuretic (uncontrolled hypertension); or = 3 antihypertensive agents at
baseline, one of which is a diuretic (treatment-resistant hypertension).
For info regarding 2023P000899
please contact Jennifer Kaufman, DNP at 617-632-8956 or
jmkaufma@bidmc.harvard.edu
Title: Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Brief Title: CAPTIVA
Brief Summary: The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death.
For info regarding 2022C000315
please contact Sarah Marchina at
smarchin@bidmc.harvard.edu
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus
Brief Title: Anifrolumab SC in SLE
Brief Summary: The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in
adult patients with moderate -to-severe SLE despite receiving standard therapy
For info regarding 2023P000200
please contact Rheumatology Clinical Research Specialist at 617-632-8658 or
skrishfi@bidmc.harvard.edu
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)
Brief Title: Deucravacitinib in SLE
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib
compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE)
population.
For info regarding 2022C000972
please contact Rheumatology Clinical Research Specialist at 617-632-8658 or
skrishfi@bidmc.harvard.edu
Title: Studies of Immune Cell Signaling and Gene Transcription in Systemic Lupus Erythematosus, Other Autoimmune Diseases and Healthy Volunteers
Brief Title: Blood Samples in Lupus, other Autoimmune Diseases
Brief Summary: This study is being done to study the natural history of Systemic Lupus Erythematosus (SLE). The causes of and the treatments for the disease will be investigated and compared to those of other autoimmune diseases and healthy controls without any autoimmune disease. Participants will be asked to donate blood (less than or equal to 100 mLs) and/or urine while they are having their clinical labs drawn, no less than every 6 weeks.
For info regarding 2006P000298
please contact Rheumatology Clinical Research Specialist at 617-632-8658 or
skrishfi@bidmc.harvard.edu
Title: Audio Markers of Speech and Cognition in Neurodegenerative Disease (Audio-ND)
Brief Title: Audio-HD
Brief Summary: The purpose of this research is to establish biomarkers (a medical sign that can be measured reliably) for both speech and cognitive impairment in Huntingtons disease using a speech analyzing application. Participants must either have a confirmed genetic diagnosis of Huntingtons disease or be
a heathy volunteer. Participants will undergo demographics and medical history review, cognitive tests, questionnaires, and a 10-minute speech assessment.
For info regarding 2022P000181
please contact Luis Sierra at 617-667-2351 or
hdresearch@bidmc.harvard.edu
Title: Neural networks in presymptomatic Huntingtons Disease
Brief Title: Neural networks in presymptomatic Huntingtons Disease
Brief Summary: The primary aim of this study is to investigate the changes in the neural networks of attention in the early “presymptomatic†phase of Huntington’s disease. The second aim is to correlate these imaging changes with performance on a cognitive/attentional task.
For info regarding 2019P000943
please contact Luis Sierra at 617-667-2351 or
hdresearch@bidmc.harvard.edu
Title: Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants
Brief Title: Clinical trial of atrial fibrillation patients comparing lef
Brief Summary: The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA
occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for
ischemic stroke and who are recommended for long-term NOAC therapy.
The clinical investigation is a prospective, randomized, multicenter active control
worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA
occlusion device ("Device Group") and a commercially available NOAC medication ("Control
Group"). The choice of NOAC in the Control Group will be left to study physician
discretion.
For info regarding 2021P000891
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation
Brief Title: Edwards PASCAL CLASP IID Pivotal Clinical Trial
Brief Summary: To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitation (FMR) on guideline directed medical therapy
(GDMT)
For info regarding 2018P000760
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial
Brief Title: APOLLO Trial
Brief Summary: Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device.
For info regarding 2022P001137
please contact Roger Laham at 617-667-8800 or
rlaham@bidmc.harvard.edu
Title: A randomized, double-blind, placebo- controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
Brief Title: 337HNAS20011 (NATiV3)
Brief Summary: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3
For info regarding 2022P000050
please contact Julie Shea at 617-632-1129 or
jmshea@bidmc.harvard.edu
Title: A randomized, double-blind, placebo- controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
Brief Title: 337HNAS20011 (NATiV3)
Brief Summary: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3
For info regarding 2022P000050
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination with Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients with Aggressive B-Cell Non-Hodgkin Lymphoma (ATHENA-1)
Brief Title: A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
Brief Summary: The study is researching an experimental drug called REGN5837 in combination with another
experimental drug, odronextamab (called "study drugs").
The aim of the study is to see how safe and tolerable the study drugs are, and to define
the recommended dose for phase 2.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drugs (that could make the drugs
less effective or could lead to side effects)
- To find out how well the study drugs work against relapsed or refractory aggressive
B-cell non-Hodgkin lymphomas (B-NHLs)
For info regarding 23-330
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE ESCALATION STUDY OF SGR-1505 AS MONOTHERAPY IN SUBJECTS WITH MATURE B-CELL MALIGNANCIES
Brief Title: Study of SGR-1505 in Mature B-Cell Neoplasms
Brief Summary: The purpose of this study is to evaluate safety and tolerability and to determine the
maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose
(RD) of SGR-1505.
For info regarding 23-253
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of Idiopathic pulmonary fibrosis (BEACON-IPF)
Brief Title: A randomized, double-blind, dose-ranging, placebo-controlled
Brief Summary: A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the
efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary
fibrosis (BEACON-IPF).
For info regarding 2023P001171
please contact Bess Flashner at 617-726-8554 or
bflashne@bidmc.harvard.edu
Title: MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer
Brief Title: Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study
Brief Summary: This phase II/III trial examines whether patients who have undergone surgical removal of
bladder, but require an additional treatment called immunotherapy to help prevent their
bladder cancer from coming back, can be identified by a blood test. Many types of tumors
tend to lose cells or release different types of cellular products including their DNA
which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes
can be seen on scans. Health care providers can measure the level of ctDNA in blood or
other bodily fluids to determine which patients are at higher risk for disease
progression or relapse. In this study, a blood test is used to measure ctDNA and see if
there is still cancer somewhere in the body after surgery and if giving a treatment will
help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab
and relatlimab, can help the body's immune system to attack the cancer, and can interfere
with the ability of tumor cells to grow and spread. This trial may help doctors determine
if ctDNA measurement in blood can better identify patients that need additional
treatment, if treatment with nivolumab prolongs patients' life and whether the additional
immunotherapy treatment with relatlimab extends time without disease progression or
prolongs life of bladder cancer patients who have undergone surgical removal of their
bladder.
For info regarding 24-138
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Causal Lesion Network Guided Treatment of Mania with Transcranial Electrical Stimulation
Brief Title: Lesion Network Guided Treatment of Mania with tES
Brief Summary: Mania is a core symptom of bipolar disorder involving periods of euphoria. Decreased
inhibitory control, increased risk-taking behaviors, and aberrant reward processing are
some of the more recognized symptoms of bipolar disorder and are included in the
diagnostic criteria for mania. Current drug therapies for mania are frequently
intolerable, ineffective, and carry significant risk for side effects. Presently there
are no neurobiologically informed therapies that treat or prevent mania. However, using a
newly validated technique termed lesion network mapping, researchers demonstrated that
focal brain lesions having a causal role in the development of mania in people without a
psychiatric history can occur in different brain locations, such as the right
orbitofrontal cortex (OFC), right dorsolateral prefrontal cortex (DLPFC), and right
inferior temporal gyrus (ITG). This lesion network evidence converges with existing
cross-sectional and longitudinal observations in bipolar mania that have identified
specific disruptions in network communication between the amygdala and ventro-lateral
prefrontal cortex. The OFC is associated with inhibitory control, risk-taking behavior,
and reward learning which are major components of bipolar mania. Thus, the association
between OFC with mania symptoms, inhibitory control, risk-taking behavior, and reward
processing suggests that this region could be targeted using non-invasive brain
stimulation.
For info regarding 2022P000295
please contact Paolo Lizano at 617-754-1227 or
plizano@bidmc.harvard.edu
Title: Psychiatric Screening Repository: Data Collection for Mental Health
Brief Title: Psychiatric Screening Repository
Brief Summary: This study aims to assess changes in thinking, mood, or behavior through a semi-structured clinical interview using well-established mental health research tools. Your data will be securely stored and may be used with your permission for other research studies. The analysis of this information will help us better understand mental health challenges in adults aged 18-65 for improved diagnoses and treatment
For info regarding 2023P000390
please contact Paolo Lizano, MD at 617-754-1227 or
plizano@bidmc.harvrd.edu
Title: Retinal Layer, Microvascular and Electroretinographic Determinants of Early Course Schizophrenia
Brief Title: Retinal Determinants of Early Course Schizophrenia
Brief Summary: Schizophrenia is a chronic disorder and is among the most highly disabling diseases in all of medicine, impacting approximately 1.5% of the population. This study will use novel state-of-the-art Electroretinography (ERG), Optical Coherence Tomography (OCT) and angiography (OCTA) imaging to capture retinal biomarkers that inform pathophysiology and clinical outcome in early course schizophrenia. This study is expected to have an impact on the growing consensus in psychiatry and neuro-ophthalmology that the retina provides a window into the brain that can be useful for understanding brain pathophysiology and for developing biomarkers of illness progression and possibly treatment response.
For info regarding 2019P000815
please contact Paolo Lizano at 617-754-1227 or
plizano@bidmc.harvard.edu
Title: Transcranial Electrical Stimulation in Psychosis Biotypes
Brief Title: tES in Psychosis Biotypes
Brief Summary: The visual system has increasingly been recognized as an important site of injury in
patients with schizophrenia and other psychoses. Visual system alterations manifest as
visual perceptual aberrations, deficits in visual processing, and visual hallucinations.
These visual symptoms are associated with worse symptoms, poorer outcome and resistance
to treatment. A recent study using brain lesion mapping of visual hallucinations and
identified a causal location in the part of the brain that processes visual information
(visual cortex). The association between visual cortex activation and visual
hallucinations suggests that this region could be targeted using noninvasive brain
stimulation. Two case studies have found that brain stimulation to the visual cortex
improved visual hallucinations in treatment resistant patients with psychosis. While
promising it is unclear whether these symptom reductions resulted from activity changes
in the visual cortex or not. Here we aim to answer the question whether noninvasive brain
stimulation when optimally targeted to the visual cortex can improve brain activity,
visual processing and visual hallucinations. The knowledge gained from this study will
contribute to the field of vision by providing a marker for clinical response and by
personalizing treatment for patients with psychosis suffering from visual symptoms. This
grant will allow us to set the foundation for a larger more targeted study utilizing
noninvasive brain stimulation to improve visual symptoms in patients with psychosis.
For info regarding 2019P001016
please contact Matcheri Keshavan at 617-998-5039 or
mkeshava@bidmc.harvard.edu
Title: Abbott DBS Post market Study of Outcomes for Indications over Time
Brief Title: ABT-CIP-10300
Brief Summary: The purpose of this international study is to evaluate long-term safety and effectiveness
of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's
disease, essential tremor or other disabling tremor and dystonia.
For info regarding 2022P000324
please contact Aine Russell at 617-667-1337 or
arussel@bidmc.harvard.edu
Title: Tablet application for the screening and monitoring of movement disorders
Brief Title: Drawing Analysis for Screening of Parkinsons Disease
Brief Summary: We are trying to develop a way to measure movement disorders in people (e.g. Parkinsons Disease). We are testing people on a variety of drawing tasks using an iPad and a stylus. We plan to analyze how people perform on the tasks. We will use this information to create more accurate, faster, and more convenient tasks and determine whether these drawing tasks will provide us with information that is useful in understanding which movement disorder a patient has or whether they do not have a movement disorder.
For info regarding 2023P000280
please contact Jay Iyer at
jiyer@bidmc.harvard.edu
Title: Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate and High-Risk Meningiomas
Brief Title: Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma
Brief Summary: RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case,
observation may be sufficient. Specialized radiation therapy that delivers a high dose of
radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and
intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to
normal tissue. It is not yet known whether observation is more effective than radiation
therapy in treating patients with meningioma.
PURPOSE: This phase II trial is studying observation to see how well it works compared
with radiation therapy in treating patients with grade I, grade II, or grade III
meningioma.
For info regarding 10-062
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema: The CONVERT II Trial
Brief Title: CONVERT II
Brief Summary: This is a prospective, open-label, multi-center, single-arm study planned to enroll 200
subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe.
Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent
assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV-
status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic
lung volume reduction (BLVR) and be followed for 24 months.
For info regarding 2024P000635
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: Combined Zephyr Valve System with Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema: A Pilot Randomized Controlled Trial
Brief Title: COMPLETE-1
Brief Summary: The purpose of this protocol is to perform a pilot prospective randomized controlled
clinical trial to evaluate the potential role of lung fissure completion strategy
(experimental intervention) in addition to endobronchial valve (EBV) placement
(representing "standard-of-care") in select patients with severe COPD/emphysema and with
evidence for <95% fissure completion between adjacent lung lobes. In select patients,
lung fissure completion strategy will be performed by either video-assisted thorascopic
surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to
reduce collateral ventilation and determine whether or not this experimental strategy
will improve outcome following subsequent EBV placement. EBV placement will follow
successful VATS-guided or robotic-guided fissure stapling.
The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on
procedure-related complications, physiological measurements (ex., FEV1 by pulmonary
function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed
for 3-month period, receiving usual standard of care during the 3 months of follow-up.
The goal of this protocol is to determine if elimination of significant collateral lung
ventilation between lung lobes is possible, and whether such strategy to eliminate
collateral lung ventilation between lobes improves outcomes following subsequent EBV
placement (i.e. promotes atelectasis of diseased lung segments) in the management of
severe COPD/emphysema in appropriate candidates. For subjects in the medical management
control group, upon completion of the 3-month F/U period, they will be eligible for EBV
if they choose.
For info regarding 2021P000049
please contact Christine Conley at 617-632-8386 or
cconley@bidmc.harvard.edu
Title: Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)
Brief Title: Effect of CPAP on 6MWT in Patients with ECAC
Brief Summary: The purpose of this protocol is to perform a prospective, randomized, double-blinded,
pacebo-controlled clinical trial to determine the influence of a non-invasive positive
pressure ventilation device on exercise capacity and symptoms in adult patients with
ECAC. Primary outcome will include the total distance traversed by the study subject
during a standard 6-minute walk test, and secondary outcomes will include peak flow
measurement and symptom reporting before and after the exercise testing. The study will
focus on the use of continuous positive airway pressure (CPAP) device. CPAP is
FDA-approved for the treatment of various medical conditions, including obstructive sleep
apnea and heart failure, but is not FDA-approved for the treatment of ECAC. The study
will enroll 32 ambulatory study subjects with confirmed ECAC at the BIDMC, and each study
subject will be monitored for up to 3 months.
For info regarding 2019P001034
please contact Christine Conley at 617-632-8252 or
TSIPResearchStaff@bidmc.harvard.edu
Title: Inter-lobar Fissure Completion as a Salvage Treatment in Patients with Failed Lung Volume Reduction (SAVED-1)
Brief Title: Rescue lung fissure closure after failed EBV therapy in COPD
Brief Summary: The purpose of this protocol is to perform a pilot prospective controlled clinical trial
to evaluate the potential role of lung fissure completion with pleural adhesiolysis
strategy (experimental intervention) in severe emphysema/COPD patients with failed
bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs)
therapy. In select patients, the lung fissure completion with adhesiolysis strategy will
be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the
lung fissures to reduce collateral ventilation with adhesions removal and determine
whether this experimental strategy will improve outcomes after failed BLVR in patients
with severe emphysema/COPD.
For info regarding 2022P000048
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: The Spiration Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Brief Title: STRIVE SVS Registry Trial
Brief Summary: This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term
safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe
emphysema in a post-market setting.
For info regarding 2021P001015
please contact Adnan Majid at 617-632-8252 or
TSIPResearchStaff@bidmc.harvard.edu
Title: A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination with Palbociclib Versus Belzutifan Monotherapy in Participants with Advanced Renal Cell Carcinoma (RCC)
Brief Title: A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of belzutifan
monotherapy and belzutifan plus palbociclib combination therapy in participants with
advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on
or after receiving prior therapy. Part 1 will establish the safety of belzutifan plus
palbociclib and determine a recommended dosage of palbociclib for the combination therapy
by ascending dose escalation. Part 2 will evaluate the efficacy and safety of belzutifan
plus palbociclib at the dosage level determined in Part 1.
For info regarding 22-234
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors -ARTISTRY-1
Brief Title: A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors
Brief Summary: To better understand the safety and tolerability of ALKS 4230 in humans
For info regarding 16-229
please contact Immuno-Oncology Group Group Box BIDMC at
Immuno-OncologyTrials@bidmc.harvard.edu
Title: A Phase 1a/1b Dose Escalation and Dose Expansion Study of NPX887 in Participants with Solid Tumor Malignancies Known to Express B7-H7/HHLA2
Brief Title: A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2
Brief Summary: NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting
B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this
first-in-human study is to learn whether NPX887 is safe and tolerable and shows a
preliminary efficacy in participants with B7-H7 (HHLA2) expressing tumors at selected
dose(s). The main questions it aims to answer are:
- what is an appropriate dose to be given to participants?
- are the side effects of treatment manageable?
- what is the preliminary anti-tumor activities?
Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their
disease has not progressed, and be closely monitored by the treating physicians.
For info regarding 24-064
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A PHASE 1A/1B STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF STK-012 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN SUBJECTS WITH SELECTED ADVANCED SOLID TUMORS
Brief Title: STK-012 Monotherapy and in Combination Therapy in Patients with Solid Tumors
Brief Summary: This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of
STK-012 as monotherapy and in combination therapy in patients with selected advanced
solid tumors.
For info regarding 22-173
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus
Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma
Brief Title: A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004).
Brief Summary: The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus
pembrolizumab in participants with renal cell carcinoma (RCC) with respect to
disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is
that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to
DFS.
For info regarding 24-181
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma (EA6141)
Brief Title: A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Brief Summary: This phase II/III trial studies the side effects of nivolumab and ipilimumab when given
together with or without sargramostim and to see how well they work in treating patients
with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may
have spread from where it first started to nearby tissue, lymph nodes, or distant parts
of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and
nivolumab, may help the body's immune system attack the cancer, and may interfere with
the ability of tumor cells to grow and spread. Colony-stimulating factors, such as
sargramostim, may increase the production of white blood cells. It is not yet known
whether nivolumab and ipilimumab are more effective with or without sargramostim in
treating patients with melanoma.
For info regarding 15-724
please contact Immuno-Oncology Group Group Box BIDMC at
Immuno-OncologyTrials@bidmc.harvard.edu
Title: HEALEY ALS Platform Trial
Brief Title: HEALEY ALS Platform Trial
Brief Summary: The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial
evaluating the safety and efficacy of investigational products for the treatment of ALS.
For info regarding 2020C000221
please contact Seward Rutkove at 617-667-8130 or
srutkove@bidmc.harvard.edu
Title: A Phase 1 Study of ASCIMINIB in combination with dasatinib, prednisone, and blinatumomab in patients with BCR-ABL1 positive (BCR-ABL1+) B-cell acute lymphoblastic leukemia (B-ALL) and chronic myeloid leukemia (CML)
Brief Title: ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
Brief Summary: This research study is evaluating a drug called ABL001 taken in combination with
dasatinib (Sprycel®) and prednisone (a steroid) as a possible treatment for B-cell Acute
Lymphoblastic Leukemia that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid
Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia
chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL).
It is expected that 40-65 people will take part in this research study.
- ABL001
- Dasatinib (Sprycel®)
- Prednisone
- Blinatumomab
For info regarding 18-170
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
Brief Title: A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Brief Summary: This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out
if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid
leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it
works for AML and MDS. A side effect is anything the drug does besides treating cancer.
This study will have seven groups or "parts."
- Part A will find out how much SEA-CD70 should be given to participants
- Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it
works to treat participants with MDS.
- Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it
works to treat participants with AML.
- Part D will find out how much SEA-CD70 with azacitidine should be given to
participants
- Part E will use the dose found in Part D to find out how safe SEA-CD70 with
azacitidine is and if it works to treat participants with MDS or MDS/AML that has
not been treated.
- Part F will use the dose found in Part D to find out how safe SEA-CD70 with
azacitidine is and if it works to treat participants with MDS or MDS/AML.
- Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should
be given to participants with AML. Also, to evaluate safety and tolerability of
PF-08046040 in combination with azacitidine and venetoclax in participants with
previously untreated AML who are unfit for standard induction chemotherapy.
For info regarding 20-191
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase I Study of M3814 In Combination with MEC in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Brief Title: Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia
Brief Summary: This phase I trial studies the best dose and side effects of M3814 when given in
combination with mitoxantrone, etoposide, and cytarabine in treating patients with acute
myeloid leukemia that has come back (relapsed) or does not respond to treatment
(refractory). M3814 may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Chemotherapy drugs, such as mitoxantrone, etoposide, and
cytarabine, work in different ways to stop the growth of cancer cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. Giving
M3814 in combination with mitoxantrone, etoposide, and cytarabine may lower the chance of
the acute myeloid leukemia growing or spreading.
For info regarding 21-011
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase Ib/II Study of the Combination of Venetoclax with Chemotherapy as Frontline Therapy in Older Patients with Acute Lymphoblastic Leukemia
Brief Title: Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
Brief Summary: This research study is studying a medication called Venetoclax and a chemotherapy regimen
as a possible treatment for Acute Lymphoblastic Leukemia.
The drugs involved in this study are:
- Venetoclax
- Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin,
dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine
For info regarding 16-648
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Venetoclax In Combination with ASTX727, an All-ORal TherapY for Chronic
Myelomonocytic Leukemia and Other MDS/MPN with Excess Blasts (VICTORY-MDS/
MPN): a Randomized, Phase 2 trial
Brief Title: Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Brief Summary: This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination
with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow
cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic
syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts. Blasts are immature
blood cells. Decitabine is in a class of medications called hypomethylation agents. It
works by helping the bone marrow produce normal blood cells and by killing abnormal cells
in the bone marrow. Cobimetinib is used in patients whose cancer has a mutated (changed)
form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It
works by blocking the action of an abnormal protein that signals cancer cells to
multiply. This helps slow or stop the spread of cancer cells. Venetoclax is in a class of
medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer
cells by blocking Bcl-2, a protein needed for cancer cell survival. The combination of
ASTX727 and venetoclax may be more effective in reducing the cancer signs and symptoms in
patients with CMML, or MDS/MPN with excess blasts.
For info regarding 24-170
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Metabolomic changes after mixed meal tolerance test as novel markers of heart failure with preserved ejection fraction disease severity
Brief Title: Metabolomic changes after MMTT in HFpEF
Brief Summary: In this study, we will look at how treatment with a class of medication called sodium glucose cotransporter 2 (SGLT2) inhibitors effects the bodys metabolic health in patients who have heart failure with preserved ejection fraction. We will test metabolism by giving a person a meal and measure how levels of small molecules change before and after the meal. We will repeat this test again after 12 weeks of treatment with SGLT2 inhibitors and
see how the molecules responses to a meal change with drug treatment.
For info regarding 2023P001112
please contact Michael Mi, MD at 617-667-8800 or
mmi@bidmc.harvard.edu
Title: Characterizing non-restorative sleep in post-viral disease to advance intervention innovations
Brief Title: Nonrestorative sleep in post-viral disease
Brief Summary: This study is being done to understand why people with (ME/CFS) and Long COVID may experience nonrestorative sleep. Non-restorative sleep means that you do not feel refreshed or well rested after sleeping. We hope to learn more about things that might affect your sleep. For example, how your bodys systems, such as your immune system (the system that helps you fight infections) and hormones (chemicals that signal different functions in your body) are related to non-restorative sleep. We hope that learning more about non-restorative sleep can help with future treatment.
For info regarding 2022P001036
please contact Janet Mullington, PhD at 617-667-5243 or
postviralsleep@bidmc.harvard.edu
Title: A Phase 2, randomized, blinded, placebo-controlled study to evaluate safety, tolerability, pharmacometrics and efficacy of DNTH103 in adults with generalized Myasthenia Gravis ( MAGIC)
Brief Title: DNTH103 in adults with generalized Myasthenia Gravis ( MAGI
Brief Summary: The purpose of this Phase 2 study is to evaluate the safety, tolerability,
pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia
gravis (gMG).
For info regarding 2024P000498
please contact Amy Lewandowski at 617-667-2545 or
alewand2@bidmc.harvard.edu
Title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
Brief Title: VR in the OR: TKA
Brief Summary: The objective of this study is to investigate whether the use of virtual reality (VR)
during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative
requirements while maintaining high levels of patient satisfaction as compared to both a
music and sham VR + usual care control.
For info regarding 2020P001176
please contact Center for Anesthesia Research Excellence at
vgoodspe@bidmc.harvard.edu
Title: Postoperative Virtual Reality (VR) for Recovery after Bariatric Surgery
Brief Title: Postoperative VR Bariatric
Brief Summary: The objective of this study is to investigate whether the addition of immersive virtual
reality (VR) in the immediate postoperative period to an enhanced recovery after surgery
(ERAS) protocol could improve postoperative recovery from bariatric surgery.
For info regarding 2020P001149
please contact Center for Anesthesia Research Excellence at
vgoodspe@bidmc.harvard.edu
Title: US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus
Brief Title: NPH eShunt Study
Brief Summary: The eShunt® System is a minimally invasive method of treating communicating
hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the
eShunt Implant, a permanent implant deployed in a minimally invasive,
neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal
fluid from the intracranial subarachnoid space to the venous system for the treatment of
patients with normal pressure hydrocephalus, reducing disability due to symptoms
including one or more of gait disturbance, cognitive dysfunction and urinary
incontinence.
For info regarding 2023P001179
please contact Christopher Ogilvy at 617-111-1111 or
cogilvy@bidmc.harvard.edu
Title: Edrn Prostate MRI Biomarker Study And Reference Set
Brief Title: EDRN Prostate MRI Biomarker Study
Brief Summary: The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the
use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate
biopsy setting given the availability of validated prostate cancer early detection
markers is uncertain.This study will allow investigators to determine if prostate MRI is
superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in
the initial biopsy setting.
For info regarding 19-334
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI therapy
Brief Title: 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI therap
Brief Summary: The study is being conducted to learn why some patients with Benign Prostatic Hyperplasia
(BPH) do not respond to a commonly used treatment drug, Finasteride. The hope is to find
ways to predict which patients will not respond to Finasteride so that, in the future,
these patients can be identified prior to offering this treatment and they can be offered
alternative treatment strategies in its place. The aim is to see if noninvasive
techniques such as MRI can detect inflammation of the prostate to assist with early
detection of those who will and who will not respond to Finasteride.
For info regarding 2020P000202
please contact Christopher Mistretta at 617-632-8432 or
cmistret@bidmc.harvard.edu
Title: Physio-Anatomy Clinical Data Collection
Brief Title: Gentuity Study
Brief Summary: This is an on-label clinical study design intended for the collection of three different
types of interventional procedural data using FDA-cleared cardiac catheterization
technologies and drugs, each used according to its product labeling and standard practice
of medicine.
For info regarding 2022P000757
please contact Eric Osborn at 617-632-7722 or
eosborn@bidmc.harvard.edu
Title: Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)
Brief Title: Physiological Assessment for Optimizing PCI
Brief Summary: Traditionally, the severity of a blockage (stenosis) in a coronary artery has been
determined by visual angiographic assessment of the diameter of the artery at the level
of a blockage compared to a normal healthy area of the same artery. With the advent of
invasive physiological testing to assess coronary blood flow, multiple clinical trials
have demonstrated a clinical benefit to a physiology-guided percutaneous coronary
intervention (PCI) approach. However, despite this and the potential for significant
variation in the interpretation of coronary artery stenosis severity by visual
angiography alone to guide PCI, invasive physiologic indices remain significantly
under-utilized.
The purpose of this study is to investigate the physiologic significance of coronary
lesions deemed angiographically severe by visual estimation that are planned for PCI. The
investigators plan to perform blinded physiologic assessment pre and post PCI. The
primary aim of the study is to determine whether a subset of lesions visually estimated
as severe by angiography treated with stent placement/PCI may in fact not be
physiologically significant when assessed invasively, and thus PCI could safely be
deferred in these patients. A secondary aim is to evaluate physiologic assessment post
PCI to detect residual ischemia that could be utilized to optimize stent placement.
For info regarding 2022P000479
please contact Eric Osborn at 617-632-7722 or
eosborn@bidmc.harvard.edu
Title: A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Newly Discovered Low to Moderate Risk Lung Nodules
Brief Title: Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
Brief Summary: This study evaluates the how addition of the Nodify XL2 test result impacts the clinical
management of newly identified solid lung nodules assessed as low to moderate risk of
cancer.
For info regarding 20-743
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2/3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Gastritis with or without Eosinophilic Duodenitis
Brief Title: Regeneron EG Study
Brief Summary: 40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned
with dupilumab or placebo subcutaneous injections every two weeks for a total of 12
weeks. Study subjects who complete the 12-week treatment phase, may continue into an open
label extension study, where dupilumab will be administered every two weeks for a total
of 24 weeks.
For info regarding 2023P000131
please contact Judy Nee at 617-667-0682 or
jnee@bidmc.harvard.edu
Title: A Multicenter rAndomized, open-label, blinded endpoint evaluation, phase 3 study comparinG the effect of abelacimab relative to daltepariN on venOus thromboLism (VTE) recurrence and bleeding in patients with gastroIntestinal (GI)/genitourinAry (GU) cancer associated VTE (Magnolia)
Brief Title: A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
Brief Summary: This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect
of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and
bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE
(Magnolia)
For info regarding 22-117
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 Study comparing the effect of abelacimab relaTive to apixaban on venous thromboEmbolism (VTE) recurrence and bleeding in patients with canceR associated VTE (ASTER)
Brief Title: A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE
Brief Summary: This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study
comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE)
recurrence and bleeding in patients with cancer associated VTE (ASTER)
For info regarding 22-116
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 study of ruxolitinib in low-risk essential thrombocythemia and polycythemia vera with significant symptom burden
Brief Title: Ruxolitinib in Thrombocythemia and Polycythemia Vera
Brief Summary: This research is being done to see if the drug ruxolitinib is effective in reducing the
symptoms caused by low-risk essential thrombocythemia (ET) and polycythemia vera (PV).
- This research study involves the study drug Ruxolitinib.
For info regarding 20-364
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A PHASE II, OPEN-LABEL, MULTI-COHORT, MULTICENTER STUDY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA AND CHILD-PUGH B7 AND B8 CIRRHOSIS
Brief Title: A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
Brief Summary: The purpose of this study is to assess the safety and efficacy of atezolizumab and
bevacizumab, or atezolizumab alone, as first-line treatment in participants with
unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with
Child-Pugh B7 or B8 cirrhosis.
For info regarding 24-268
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Role of Contrast Enhanced Spectral Mammography to predict upgrade rates of biopsy proven atypical ductal hyperplasia
Brief Title: Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia
Brief Summary: This research study is studying whether contrast enhanced mammography can predict if
atypical ductal hyperplasia will progress to cancer.
The device involved in this study is:
-Contrast enhanced mammography
For info regarding 17-694
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Topical OA-3, a PAR2 Inhibitor, in Adult Healthy Volunteers and Subjects with Atopic Dermatitis and Pruritus
Brief Title: Phase 1a/1b Study Efficacy of Topical OA-3, a PAR2 Inhibitor
Brief Summary: The purpose of this study is to help us understand the safety and the potential effectiveness a new topical study drug called OA-3 hydrogel for the treatment of atopic dermatitis (AD), or eczema. This study will be open to atopic dermatitis patients and healthy patients.
For info regarding 2023P000228
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis (EFC17559)
Brief Title: EFC17559: Ph 3 AD Amlitelemab COAST 1 study
Brief Summary: This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind,
placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with
moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled
with topical prescription therapies or when those therapies are not advisable.
The purpose of this study is to measure the efficacy and safety of treatment with
amlitelimab solution for SC injection compared with placebo in participants with moderate
to severe AD aged 12 years and older.
Study details include:
At the end of the treatment period, participants will have an option to enter a separate
study: the blinded extension study EFC17600 (ESTUARY).
For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study
duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized
double-blind period, and a 16-week safety follow-up.
For participants entering the blinded extension Study EFC17600 (ESTUARY), the study
duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week
randomized double-blind period.
The total treatment duration will be up to 24 weeks. The total number of visits will be
up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600]
(ESTUARY).
For info regarding 2024P000425
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)
Brief Title: SWITCH-UP (M24-601)
Brief Summary: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to
inflammation of the skin. Therapies spread over the skin may not be enough to control the
AD in trial participants who require systemic anti-inflammatory treatment. This study
aims to provide data on the efficacy and safety of upadacitinib at different doses in
adult participants with moderate to severe AD.
Upadacitinib is an approved drug for the treatment of moderate to severe atopic
dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are
randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A
or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may
have their dose increased to upadacitinib Dose B after 2 weeks. In Period 2, participants
that completed Period 1 will either remain on their assigned dose or be reassigned to a
different dose based on their Eczema Area and Severity Index (EASI) response.
Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are
current users of dupilumab and had a history of inadequate response to dupilumab will be
enrolled at up to 94 sites worldwide.
The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a
24-week Open-Label Period 2 for participants that completed Period 1. Participants will
receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection
every other week for 32 weeks and followed for 30 days.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital
or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.
For info regarding 2024P000456
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Subjects with In-stent Restenosis
Brief Title: Selutions DCB
Brief Summary: Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical
trial.
Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will
be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be
randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include
contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES]
only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.
The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group
vs. the SELUTION SLR™ 014 DEB in all patients.
For info regarding 2023P000322
please contact Marie-France Poulin at
mpoulin@bidmc.harvard.edu
Title: Evolut TM EXPAND TAVR II Pivotal
Brief Title: Evolut TM EXPAND TAVR II Pivotal
Brief Summary: Obtain safety and effectiveness data to support indication expansion for the Medtronic
TAVR System to include patients with moderate, AS.
For info regarding 2022P000961
please contact Marie-France Poulin at
mpoulin@bidmc.harvard.edu
Title: A RANDOMIZED DOUBLE-BLIND TRIAL OF ABATACEPT EXTENDED DOSING VERSUS ABATACEPT SHORT-TERM DOSING FOR GRAFT VERSUS HOST DISEASE PROPHYLAXIS: ABA3
Brief Title: Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
Brief Summary: This is a multicenter randomized, double blind, Phase 2 trial for patients receiving
transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of
abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin
inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve
outcomes in patients with a minimum follow-up of one year post-transplant. All patients
will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose,
patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of
placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary
endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival
(SGRFS). The study will end when the last patient has reached 2 years after transplant.
Results will first be calculated and the study unblinded when the last patient has
reached one year post-transplant.
For info regarding 20-227
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Study of Alisertib in Patients with Extensive Stage Small Cell Lung Cancer
Brief Title: A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Brief Summary: PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with
pathologically-confirmed small cell lung cancer (SCLC) following progression on or after
treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to
one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two
prior lines of therapy. This study is intended to identify the biomarker-defined
subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy,
safety, and pharmacokinetics of alisertib.
For info regarding 24-374
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A randomized study investigating the pharmacokinetics of standard interval dosing compared to extended interval dosing of nivolumab or pembrolizumab in locally advanced or metastatic cancers
Brief Title: Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
Brief Summary: A randomized research study of drugs nivolumab and pembrolizumab in patients with locally
advanced or metastatic cancers. Based on data from earlier studies it appears that the
drugs can be given less often then the currently approved schedule. This trial will
compare drug levels from the blood from standard interval dosing levels versus taking the
drugs less often.
For info regarding 21-069
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A randomized, phase 3, open-label study to evaluate sigvotatug vedotin compared with docetaxel in adult participants with previously treated non-small cell lung cancer (Be6A Lung-01)
Brief Title: A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer (Be6A Lung-01).
Brief Summary: This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC).
Participants in this study must have cancer that has spread through their body or can't
be removed with surgery. Participants in this study must have been treated with no more
than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors
that have certain treatable genomic alterations must have had at least 1 drug for that
genomic alteration, in addition to platinum-based chemotherapy.
This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type
of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill
them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer
drug that has been approved to treat non-small cell lung cancer. It is usually given to
patients who previously received another anticancer treatment. In this study, one group
of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A
second group of participants will get docetaxel on Day 1 during each 21-day cycle.
This study is being done to see if sigvotatug vedotin works better than docetaxel to
treat participants with NSCLC. This study will also test what side effects happen when
participants take these drugs. A side effect is anything a drug does to the body besides
treating the disease.
For info regarding 24-416
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Brief Title: Nitrous Oxide during Vasectomy
Brief Summary: A vasectomy is a common procedure done as a form of permanent male birth control. For some patients, a vasectomy can cause anxiety or pain. Nitrous oxide (or laughing gas) is a well-known sedative which is frequently used in dental offices and for pediatric procedures to reduce anxiety and pain. This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful for improving experience of care during vasectomy. We use the term SANO to describe participants holding a mask to their face and using a remote control to adjust the nitrous oxide levels up or down to their desired effect. The system limits the nitrous oxide levels so that the level cannot go above a fixed limit (50% nitrous oxide).
For info regarding 2023P000328
please contact Heidi Rayala at 617-903-0153 or
SANO@bidmc.harvard.edu
Title: A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
Brief Title: HEPA RCT in COPD
Brief Summary: This study evaluates the influence of home air purification on the lung health of adults
with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA
filters) and half will receive sham air purifiers.
For info regarding 2019P001129
please contact Mary Rice at 617-667-0000 or
mrice1@bidmc.harvard.edu
Title: A prospective observational study comparing antepartum and postpartum range of motion(ROM) in adults with limited joint mobility
Brief Title: A prospective observational study of antepartum and postpart
Brief Summary: This is an observational and physiological study of healthy subjects with prior injuries to ankle, knee, elbow, or shoulder to determine if their range of motion improves over the course of normal pregnancy, presumably as a result of relaxin hormone.
For info regarding 2023P000634
please contact Michael Akodu at 857-395-1119 or
makodu@bidmc.harvard.edu
Title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary
Efficacy of BMS-986393 in Novel Combinations in Participants with Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component (Phase I GPRC5D Combo)
Brief Title: A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
Brief Summary: The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in
combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed
and/or refractory multiple myeloma (RRMM).
For info regarding 23-696
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of MEDI2228 in Subjects with Relapsed/Refractory Multiple Myeloma
Brief Title: MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
Brief Summary: The purpose of this study is to assess the safety, pharmacokinetics and tolerability,
describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose
(MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for
single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant
ineligible or post autologous stem cell transplant and are relapsed/refractory.
For info regarding 18-165
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA
Brief Title: MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
Brief Summary: The purpose of this study is to determine the Recommended Phase 2 Dose and clinical
benefit of elranatamab in combination with other anti-cancer therapies in participants
with multiple myeloma.
For info regarding 22-166
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies
Brief Title: MMRF Molecular Profiling Protocol
Brief Summary: This protocol is now being used as screening for the MyDRUG study
For info regarding 17-336
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE
Brief Title: Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Brief Summary: This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene
vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing
information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation
and Mitigation Strategies (REMS) qualified sites approved for commercial administration
of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of
nonconforming idecabtagene vicleucel.
Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet
commercial release specifications but may be acceptable for use as an investigational
product in the Expanded Access Protocol setting.
For info regarding 21-072
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma, including Long-term Safety Follow-up
Brief Title: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma
Brief Summary: Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and
refractory multiple myeloma and includes long-term safety follow-up.
For info regarding 19-253
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase 2, Multi-Center, Single-Arm, Open-Label Study to evaluate the efficacy and safety of the combination regimen Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma
Brief Title: Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM
Brief Summary: This research is testing whether the investigational drug isatuximab is safe and
effective when used in combination with standard agents for the treatment of newly
diagnosed multiple myeloma.
For info regarding 20-207
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Electrophysiological and ultrasound quantitative biomarkers for myofascial pain
Brief Title: Quantitative biomarkers for myofascial pain
Brief Summary: This is an observational study that is intended to determine the capacity of three
technologies to serve as diagnostic biomarkers for myofascial pain syndrome.
Investigators will seek patients with myofasical pain syndrome as well as healthy
subjects for this study. Electrical impedance myography (EIM), myofiber threshold
tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE)
measurements will be obtained from the trapezius muscle (the muscle that extends over the
back of the neck and shoulders). These measurements will be repeated within 2-5 days to
assess repeatability of these methods.
For info regarding 2022P000543
please contact Seward Rutkove at 617-667-8130 or
srutkove@bidmc.harvard.edu
Title: A Prospective, Randomized, Open-Label Study to Examine The Effects of a Pressure-Enabled Drug Delivery Device on Radiotracer Distribution Compared to a Standard Microcatheter in the Context of Radioembolization
Brief Title: Pressure-enabled Delivery in Radioembolization (TriNav Study)
Brief Summary: The purpose of the study is to determine if the type of catheter used in the mapping
procedure prior to radioembolization improves the delivery of radioactivity to tumor(s)
in participants with liver cancer.
The name of the devices involved in this study are:
- Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System
- Standard 2.4F microcatheter, not otherwise specified
For info regarding 21-351
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)
Brief Title: Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
Brief Summary: This is a prospective, multi-center, open-label study to evaluate the effectiveness and
safety of Eye90 microspheres® in the treatment of subjects with unresectable
Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing
yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for
the treatment of liver tumors.
For info regarding 23-532
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Confocal Laser Endomicroscopy as an IMaging Biomarker (CLIMB study) for the Diagnosis of Pancreatic Cystic Lesions
Brief Title: Confocal Laser Endomicroscopy As an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Brief Summary: The study schema is shown in Figure 4. (A) All patients referred to one of the
participating academic centers for EUS evaluation of the PCL will be enrolled in the
protocol if they satisfy inclusion criteria. Patient consent will be obtained during the
clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B)
followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for
CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for
molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized
for the most likely diagnosis. Based on institutional multidisciplinary tumor board
meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold
standard" for diagnosis. It is anticipated that the majority of patients will undergo
surgical resection after their EUS.
For info regarding 23-328
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion AAA - SHAPE Pivotal Trial CRD 1029 November 7, 2023, Version 12
Brief Title: AAASHAPE MEMORY
Brief Summary: To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the
percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as
an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial
subjects considered candidates for elective EVAR.
For info regarding 2024P000223
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)
Brief Title: ADVANCE Trial
Brief Summary: The purpose of this trial is to generate clinical evidence related to key performance
outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder
Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are
randomized and imaging collected at all follow-up time points to assess the primary
endpoint.
For info regarding 2022P000523
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: Zenith Fenestrated+ Endovascular Graft Clinical Study Global Clinical Number 17-07
Brief Title: FEN PLUS
Brief Summary: The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and
effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with
the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2
for the treatment of patients with aortic aneurysms involving one or more of the major
visceral arteries.
For info regarding 2023P000909
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: stAAAble Trial: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy
Brief Title: STAAABLE TRIAL
Brief Summary: The purpose of this randomized clinical trial is to treat patients with small to
mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a
locally delivered, single-dose endovascular treatment. The main question the study aims
to answer is to demonstrate efficacy of the product for stabilization of these small to
mid-sized AAA.The study will compare the treatment group to the typical standard of care
for these patients, surveillance. All subjects will be followed at designated intervals
at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5
years.
For info regarding 2024P000038
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: Decisions About Cancer Screening in Alzheimer's Disease
Brief Title: Decisions About Cancer Screening in Alzheimer's Disease
Brief Summary: The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study tests if an
evidence-based decision aid for dementia caregivers can support decision-making about
mammography and improve the quality of medical decision-making about breast cancer
screening. This large randomized controlled trial will recruit up to 450 dyads (900
individual participants) of older women with dementia and a family caregiver, for a goal
of 426 dyad baselines (852 individual participants).
For info regarding 19-592
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Discussions of Prognosis and Stopping Cancer Screening in Older Adults
Brief Title: Discussing Stopping Cancer Screening and Prognosis With Older Adults
Brief Summary: Guidelines recommend not screening adults with <10-year life expectancy for cancer;
however, primary care physicians feel uncomfortable talking to older adults about
prognosis. The investigators aim to determine whether providing PCPs with scripts on
patient prognosis and older adults with information on their prognosis would be useful
when recommending stopping cancer screening.
For info regarding 19-705
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older
Brief Title: Trial of a Mammography Decision Aid for Women Aged 75 and Older
Brief Summary: The aim of this study is to test whether an educational pamphlet on mammography designed
for women aged 75 and older improves older women's decision-making around mammography
screening. The investigators aim to show that the educational pamphlet improves older
women's knowledge of the pros and cons or screening and leads to fewer women in poor
health with short life expectancy being screened.
For info regarding 19-707
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Testing a conversation aid on mammography screening for clinicians and women 75 and older in practice
Brief Title: Testing Conversation Aid in Practice
Brief Summary: The goal of this research study is to develop and test a website to help primary care
providers (PCPs) discuss the pros and cons of mammography with women aged 75 and older
and to help participants make decisions about mammography.
For info regarding 23-201
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Brief Title: Elegance
Brief Summary: The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including
populations previously not represented in Peripheral Vascular Disease (PVD) trials,
health economics data, and to support the safe use of commercially available Boston
Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in
the peripheral vasculature.
For info regarding 2021P000937
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: Medtronic The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM)
Brief Title: SPYRAL AFFIRM
Brief Summary: The purpose of this single-arm interventional study is to evaluate the long-term safety,
efficacy, and durability of the Symplicity Spyral system in subjects treated with renal
denervation.
Additionally, long-term follow-up data will also be collected from eligible subjects
previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED
studies.
For info regarding 2022P000646
please contact Eric Secemsky at 617-632-7701 or
esecemsk@bidmc.harvard.edu
Title: A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
Brief Title: A Study of SGN-B6A in Advanced Solid Tumors
Brief Summary: This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with
pembrolizumab, with or without chemotherapy, to find out whether it is safe for people
who have solid tumors. It will study sigvotatug vedotin to find out what its side effects
are. A side effect is anything the drug does besides treating cancer. It will also study
whether sigvotatug vedotin works to treat solid tumors.
The study will have four parts.
- Part A of the study will find out how much sigvotatug vedotin should be given to
participants.
- Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is
and if it works to treat solid tumors.
- Part C of the study will find out how safe sigvotatug vedotin is in combination with
these other drugs.
- Part D will include people who have not received treatment. This part of the study
will find out how safe sigvotatug vedotin is in combination with these other drugs
and if these combinations work to treat solid tumors.
- In Parts C and D, participants will receive sigvotatug vedotin with either:
- Pembrolizumab or,
- Pembrolizumab and carboplatin, or
- Pembrolizumab and cisplatin.
For info regarding 20-383
please contact Phase I Oncology at 617-975-7452 or
PIO@bidmc.harvard.edu
Title: A Phase 1 Study with ABBV-CLS-484 Alone and in Combination in Subjects with Locally Advanced or Metastatic Tumors
Brief Title: Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Brief Summary: The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-484 as
monotherapy and in combination with a PD-1 targeting agent or with a or a vascular
endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).
The trial aims to establish a safe, tolerable, and efficacious dose of ABBVCLS-484 as
monotherapy and in combination. The study will be conducted in three parts. Part 1
Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion
(Monotherapy and Combination therapy).
Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible
subjects who have advanced solid tumors.
Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a
PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid
tumors.
Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined
recommended dose in subjects with locally advanced or metastatic, relapsed or refractory
head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung
cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will
also be administered at the determined recommended dose in combination with a PD-1
targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic,
HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
For info regarding 23-138
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Brief Title: ASPIRE
Brief Summary: Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in better
functional outcomes as measured by the modified Rankin Scale.
For info regarding 2019C000787
please contact Magdy Selim at 617-632-8913 or
mselim@bidmc.harvard.edu
Title: StATins Use in intRacereberal hemorrhage patieNts
Brief Title: (Statins in ICH (SATURN Trial)
Brief Summary: The SATURN trial aims to determine whether continuation vs. discontinuation of statin
drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and
whether the decision to continue/discontinue statins should be influenced by an
individual's Apolipoprotein-E (APOE) genotype.
An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate
the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and
ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of
hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on
baseline MRI influences the risk of ICH recurrence on/off statin therapy.
For info regarding 2018C000515
please contact Magdy Selim at 617-632-8913 or
mselim@bidmc.harvard.edu
Title: Treating Hyperexcitability in Alzheimers Disease with Levetiracetam to Improve Brain Function and Cognition
Brief Title: Treating Hyperexcitability in AD with LEV
Brief Summary: The aim of this study is to explore the relationship between cortical hyperexcitability,
abnormalities of brain network function, and cognitive dysfunction in human patients with
AD and whether administration of the antiepileptic medication levetiracetam (LEV)
normalizes these measures and improves cognition.
For info regarding 2019P000091
please contact Carol Abedelnour at 617-667-0386 or
cabedeln@bidmc.harvard.edu
Title: Evaluation of Vaccine induced Immune Activity against SARS-CoV-2 and RSV (IVY-6-sera)
Brief Title: IVY-6 Vaccine Activity
Brief Summary: The purpose of this study is to understand immune responses in people who receive FDA-approved SARS-CoV-2 (COVID) or RSV vaccines. This will help figure out if the SARS-CoV-2 or RSV vaccines will work against the viruses. We also want to figure out if your immune response is protective against new forms of the virus. We will obtain blood from individuals vaccinated against SARS-CoV-2 or RSV who meet eligibility criteria before
vaccine dose, at 3 to 6 weeks after a vaccine dose and/or 12 to 16 weeks after a vaccine dose. For SARS-CoV-2, the collection of blood from fully vaccinated individuals will help ensure that the data generated from antigenic studies is consistent and can be compared over time.
For info regarding 2023P001072
please contact ED Research Team at 6170650-0042 or
cottanel@bidmc.harvard.edu
Title: Multicenter SymphonyTM IL-6 Monitoring Sepsis ICU Validation Study
Brief Title: CES-0008
Brief Summary: The primary objective of this discarded/blood draw study is to validate an IL-6 concentration cutoff and optimal time points for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.
For info regarding 2024P000354
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: Predicting anemia in conjunctiva using a smartphone app
Brief Title: Conjunctiva app
Brief Summary: The purpose of the study is to help us learn if a color scale mobile application (app) is able to give researchers useful information to use in a medical setting in diagnosing patients with anemia (low red blood cell levels). You may help the study doctors gather data to develop an inexpensive and faster system that could be used in other medical settings to diagnose anemia at the bedside where lab results cannot be easily obtained.
For info regarding 2020P000111
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients with Advanced/Metastatic Solid Tumors
Brief Title: A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Brief Summary: This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and
tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
For info regarding 22-558
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Study of Dostarlimab in Combination with Cobolimab in Advanced Cervical Cancer
Brief Title: Dostarlimab and Cobolimab in Advanced Cervical Cancer
Brief Summary: This research is being done to determine how effective dostarlimab in combination with
cobolimab is in metastatic or recurrent cervical cancer.
For info regarding 23-560
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase 2, randomized, trial of maintenance Letrozole/Abemaciclib vs Pembrolizumab after systemic therapy in patients with advanced or recurrent estrogen receptor positive, mismatch repair proficient, TP53 wild-type endometrial cancer
Brief Title: ALPINE: Maintenance Letrozole/Abemaciclib Vs Pembrolizumab
Brief Summary: A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together
followed by pembrolizumab maintenance for two years. This treatment regimen has shown
benefit in terms of delaying cancer progression in prior clinical trials, but the benefit
of the pembrolizumab maintenance treatment and whether all participants need it is
unclear. This research is being done on the maintenance portion of treatment to compare
the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone
following chemotherapy and pembrolizumab.
The names of the study drugs involved in this study are:
- Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)
- Letrozole (a type of aromatase inhibitor)
- Pembrolizumab (a type of monoclonal antibody)
For info regarding 23-695
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-101 for the Prevention of Gluten-Specific T Cell Activation in Subjects with Celiac Disease on a Gluten-Free Diet
Brief Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose
Brief Summary: The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and
immune activation in adult participants with celiac disease (CeD) on a gluten-free diet
(GFD).
Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All
participants will receive active treatment at Week 24.
For info regarding 2022P000794
please contact Jocelyn Silvester at 617-667-8374 or
jsilves2@bidmc.harvard.edu
Title: Parkinson’s Foundation PD GENEration Genetic Registry
Brief Title: Parkinson’s Foundation PD GENEration Genetic Registry
Brief Summary: To assess the feasibility, impact, and participant satisfaction of offering Clinical
Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical
care for People with Parkinson's disease (PWP).
For info regarding 2021P000373
please contact Aine Russell at 617-667-9885 or
arussel2@bidmc.harvard.edu
Title: Parkinsons Disease Repository
Brief Title: Parkinsons Disease Repository
Brief Summary: The purpose of this protocol is to establish a repository of patients with Parkinsons disease (PD) or parkinsonism and collect a range of variables to inform future research project development, future research questions and overall program development. This repository will also aid in the facilitation and coordination of patient engagement in research protocols, collect screening information, and track patients through ongoing and completed studies and study-related procedures.
For info regarding 2023P000893
please contact Aine Russell at 617-667-2351 or
arussel2@bidmc.harvard.edu
Title: Measuring Skin Elasticity in Lymphedema Patients
Brief Title: Measuring Skin Elasticity in Lymphedema Patients
Brief Summary: This protocol will utilize the lymphedema indentometer, or durometer (a novel,
noninvasive piece of equipment that measures skin elasticity), to better characterize
disease progression in patients with lymphedema. Beth Israel Deaconess Medical Center
patients who undergo treatment of lymphedema will be candidates for this noninvasive
test. This device and the data it generates will help understand the incidence of
lymphedema at Beth Israel Deaconess Medical Center compared to national data and the
outcomes of surgical treatment of lymphedema.
For info regarding 2024P000442
please contact Dhruv Singhal at 617-667-7000 or
dsinghal@bidmc.harvard.edu
Title: Variable anatomy & function of the arm?s alternate lymphatic pathway
Brief Title: Mapping and Quantifying Lymphatic Drainage of the Arm's Alternate Pathway
Brief Summary: Using indocyanine green (ICG) lymphography and lymphoscintigraphy with SPECT/CT imaging,
the aim is to evaluate the anatomy of the lymphatic system pathway in two separate
populations: healthy female volunteers and women with a history of breast cancer who did
not develop lymphedema.
For info regarding 21-324
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Variable anatomy & function of the arm’s alternate lymphatic pathway
Brief Title: The M-S Pathway: anatomy and function
For info regarding 2021P000209
please contact Angela Chen at 617-632-7827 or
lymphaticresearch@bidmc.harvard.edu
Title: Prevalence and impact of obstructive sleep apnea in multiple sclerosis
Brief Title: Prevalence and impact of obstructive sleep apnea in multiple
Brief Summary: This study will evaluate the influence of sleep apnea on clinical and radiological
features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely
detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep
studies) of MS patients will be collected and analyzed. This will be done to study
correlations between MRI, clinical data, lab studies and sleep studies. There is specific
interest in the type of sleep apnea associated with MS, and whether MRI or clinical
metrics of MS severity correlate with presence or absence of sleep apnea.
For info regarding 2019P000494
please contact Vikrum Singh at 617-667-3726 or
vsingh4@bidmc.harvard.edu
Title: TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER
Brief Title: Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
Brief Summary: The purpose of this study is to compare the effects on low risk breast cancer receiving
usual care that includes regional radiation therapy, with receiving no regional radiation
therapy. Researchers want to see if not giving this type of radiation treatment works as
well at preventing breast cancer from coming back.
For info regarding 19-720
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Data and Tissue Repository to Facilitate Infectious Diseases Research and Advance Pandemic Preparedness, with a Focus on Respiratory Pathogens
Brief Title: A Data and Tissue Repository for Respiratory Pathogens
Brief Summary: The purpose of this study is to collect samples and clinical information from people with symptoms of an acute respiratory illness, such as cough, fever and muscle pain. These are symptoms that are typical of influenza, COVID-19 and other viral infections. We are also collecting samples from people without any symptoms. The goal of the study is to store these samples to help researchers prepare for future outbreaks of infectious diseases.
For info regarding 2023P001078
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: General Pre-Trial Screening Protocol for Enrollment of Volunteers into Infectious Diseases Research Protocols
Brief Title: General Pre-Trial Screening Protocol
Brief Summary: The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) at BIDMC. This protocol will help us to determine whether a volunteer is eligible for completing the screening process, and which protocols they may be good candidates for.
For info regarding 2023P000266
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: HVTN 142: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the HCMV-HIV Vaccine Candidate VIR-1388 in Adult Participants with Overall Good Health and Without HIV
Brief Title: HVTN 142
Brief Summary: The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity
of VIR 1388 in adults in good health without HIV.
For info regarding 2023C000259
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: HVTN 307: A phase 1 clinical trial to evaluate the safety and immunogenicity of ferritin nanoparticles expressing native-like HIV-1 envelope trimers followed by boost with mRNA lipid nanoparticles encoding a native-like HIV-1 envelope trimer in adults without HIV
Brief Title: HVTN 307
Brief Summary: This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of
immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing
antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs
expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP
(V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin
NP design.
For info regarding 2023C000500
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: SARS-CoV-2 Household Transmission Study
Brief Title: SARS-CoV-2 Household Transmission Study
Brief Summary: We are conducting this study to see how SARS-CoV-2 is transmitted from one person to another within a household, and to see if COVID-19 vaccination can help prevent SARS-CoV-2 transmission. We are enrolling people who have recently tested positive for COVID-19 (or were recently exposed or have symptoms of COVID-19), as well as people who live in a household with someone who potentially might have COVID-19. The study lasts up to 4 weeks. If you participate, we will ask you to swab your nose every day for 14 days so we can test for COVID19. We will also ask for a couple blood draws, but these are optional. You would receive up to $50 to compensate you for participation.
For info regarding 2022P000021
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason in Patients with Sub-Optimal Unenhanced Echocardiography
Brief Title: Lumason bolus vs infusion
Brief Summary: A phase III study designed as a randomized, within-patient comparison of continuous
infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for
degree of LVO and assessment of LV EBD (co-primary endpoints).
For info regarding 2024P000127
please contact Jordan Strom at 617-667-7000 or
jstrom@bidmc.harvard.edu
Title: Brain Health with Inner Engineering- Longitudinal Study of Shambhavi Mahamudra Kriya Meditation (BLISS)
Brief Title: BLISS
Brief Summary: This study will explore whether a 21-minute meditation practice called Shambhavi
Mahamudra Kriya leads to changes in brain health and explore how it affects cognitive and
physiological function.
For info regarding 2022P000296
please contact Sepideh Hariri at 617-278-8082 or
shariri1@bidmc.harvard.edu
Title: BRANCH: Brain Age and Sleep Architecture in Meditators
Brief Title: BRANCH: Brain Age and Sleep Architecture in Meditators
Brief Summary: This is a single-center, cross-sectional study that will recruit approximately fifty (50)
meditators and fifty controls. Individuals that have learned at least the Shambhavi
Mahamudra Kriya practice and live in Massachusetts will be mailed a DREEM EEG device, and
a sleepimage ring. Participants will be asked to wear the two devices while sleeping for
three consecutive weekday nights (Sunday night to Thursday night) and two weekend nights
(Friday and Saturday nights). While meditating during the day, participants will only
wear the DREEM EEG headband. Participants will also undergo neurocognitive tests from the
NIH toolbox during one virtual visit via video call. Meditators who join the study will
be asked to invite a control subject to the study, matched for age and comorbidities.
For info regarding 2022P000597
please contact Sepideh Hariri, PhD at 617-667-2721 or
sadhugurucenter_research@bidmc.harvard.edu
Title: Cognitive Function and Affective Regulation in Meditators
Brief Title: CALM
Brief Summary: This research is being done to assess the impact of meditation practice on cognitive function and emotional regulation. We are also looking to assess its impact on positive and negative emotions, feelings of stress, anxiety, and depression. You will be asked to complete a set of online cognitive tasks as well as a detailed survey at a singular time-point after the time of consent.
For info regarding 2023P000588
please contact Ashwin Swaminathan at 617-278-8150 or
Sadhgurucenter_research@bidmc.harvard.edu
Title: Effects of the Orexin Receptor Antagonist Suvorexant on Sleep Architecture and Delirium in the Intensive Care Unit: a Randomized Controlled Trial
Brief Title: Suvorezant and sleep/delirium in ICU patients
Brief Summary: Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on
nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical
patients recovering in the cardiac intensive care unit (ICU). The study include patients
= 60 years old undergoing coronary artery bypass graft surgery (CABG), with or without
valve surgery (aortic or mitral). Patients will receive either oral suvorexant or placebo
for 7 nights starting the night after extubation. The primary hypothesis is that
suvorexant compared with placebo decreases WASO, as measured by a specialized
electroencephalogram (EEG), the SedLine monitor, during the first night in the cardiac
ICU. Investigators will also assess total sleep time (TST), time to sleep onset (TSO),
and postoperative delirium and delirium-free days.
For info regarding 2019P000759
please contact Center for Anesthesia Research Excellence at
vgoodspe@bidmc.harvard.edu
Title: Investigating Changes in Anxiety, Sleep Duration and Quality after Shoonya Meditation Practice
Brief Title: RESET
Brief Summary: This study aims to investigate the effects of Shoonya Meditation (taught by the Isha Foundation) on sleep, anxiety, and stress through validated surveys, and sleep data. The control group will consist of individuals who have learned and practice Shambhavi Mahamudra Kriya, also offered by the Isha Foundation.
For info regarding 2024P000521
please contact Alex-Maree Roberts at
amrobert@bidmc.harvard.edu
Title: Meditation and Breathing for Mental Health in Parkinson’s Disease Patients
Brief Title: Yoga for Parkinson’s
Brief Summary: This study is a waitlisted randomized controlled trial. We aim to assess the level of
compliance for those learning the intervention and to evaluate the impact of the practice
on neuropsychological and somatic outcomes using validated scales. Enrollment into the
study will be ongoing until we are able to get a sufficient sample size as described in
the "Statistical Consideration" section. Upon enrollment and randomization, surveys will
be administered to both the intervention and control groups at four time-points:
baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be
collected weekly for 12 weeks for both groups.
For info regarding 2022P000212
please contact Sadhguru Center for a Conscious Planet Study Team at
SadhguruCenter_Research@bidmc.harvard.edu.
Title: PANDORA: Scheduled prophylactic 6-hourly intravenous acetaminophen to prevent postoperative delirium in older cardiac surgical patients
Brief Title: PANDORA:Delirium prevention after cardiac surgery using IV
Brief Summary: Our objective is to find an effective prophylactic intervention by evaluating IV
acetaminophen's impact in reducing the frequency of postoperative delirium, one of the
most common and detrimental complications of cardiac surgery in older adults.
For info regarding 2019P000758
please contact Center for Anesthesia Research Excellence at
vgoodspe@bidmc.harvard.edu
Title: REST: Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators
Brief Title: Sleep Architecture in Shoonya Meditators
Brief Summary: This study aims to investigate the effect of a 15-minute meditation practice on sleep
architecture and high-frequency Heart Rate Variability (HF-HRV), as well as cognitive
performance after both a well-rested and sleep-deprived night.
For info regarding 2021P000544
please contact Akshaj Joshi at 617-278-8058 or
sadhgurucenter_research@bidmc.harvard.edu
Title: Yogic Breathing and Guided Meditation for Long Covid Symptoms
Brief Title: Covid No Longer
Brief Summary: This study aims to assess the impact of brief digitally delivered breathing practice and
guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.
For info regarding 2021P000552
please contact Balachundhar Subramaniam at 617-754-2721 or
bsubrama@bidmc.harvard.edu
Title: Identifying dynamic biomarkers associated with rTMS response in depression: a pilot study
Brief Title: Dynamic biomarkers of rTMS response in depression
Brief Summary: Repetitive transcranial magnetic stimulation (rTMS) is a highly effective for medication-resistant depression. For treatment to be effective, individuals invest extensive time and money undergoing rTMS daily for six weeks. However, rTMS is only 30-50% effective, and individuals may not know if they have responded until the middle or end of treatment course. Here, we aim to collect EEG and MRI data throughout rTMS treatment in patients undergoing rTMS at the Berenson-Allen Center - by doing so, we hope to identify signals that predict response early on in treatment course.
For info regarding 2023P000469
please contact Roscoe Brady Jr. MD PhD at 617-754-1261 or
robrady@bidmc.harvard.edu
Title: Alcoholic Hepatitis Network Clinical Study
Brief Title: AlcHepNet Clinical Study
Brief Summary: The purpose of this research study is to create a clinical database and bio-repository.
To do this, we will obtain blood, urine, saliva, and stool samples (e.g., biological
samples) and personal health information from you to use in future research studies
related to alcoholic hepatitis or other diseases. Part of your blood sample will be used
to extract your DNA. DNA is the genetic material that gives us unique characteristics. We
are doing this research study because we are trying to find out more about how and why
illnesses related to alcoholic hepatitis or other diseases occur in people. To do this,
we will study the biological samples and personal health information from healthy and
sick people.
A "biological sample" is usually blood, but can be any body fluid. "Personal Health
Information" includes such items as your name, age, gender, race, and/or your medical
information. It can also include data from measurements and tests that you had while
participating in another research study or that were done during the course of your
regular medical care or doctor visits.
For info regarding 2019C000971
please contact Liver Center Trials Office at 617-667-9050 or
gszabo1@bidmc.harvard.edu
Title: Immune and metabolic characterization of patients with alcohol-associated hepatitis
Brief Title: Characterization of AH
Brief Summary: This research study aims to establish a clinical database and biorepository to gain a deeper understanding of the causes and mechanisms of illnesses like alcoholic-associated hepatitis and other diseases. This involves the collection of blood samples (referred to as biological samples) and personal health information from both healthy and sick participants for potential use in future investigations into alcoholic-associated hepatitis or other diseases. A biological sample typically refers to blood but may include any bodily fluid. Personal Health Information encompasses details such as name, age, gender, race, and medical history, as well as data from prior research participation or routine medical examinations.
For info regarding 2024P000164
please contact Ruchi Chauhan at 617-735-2886 or
rchauhan@bidmc.harvard.edu
Title: PREVENT VILI: Prevention of Ventilator Induced Lung Injury
Brief Title: PREVENT VILI: a multicenter RCT of ventilation for ARDS
Brief Summary: The goal of this interventional study is to compare standard mechanical ventilation to a
lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress
Syndrome (ARDS). Participants will be ventilated according to one of two different
strategies. The main question the study hopes to answer is whether the personalized
ventilation strategy helps improve survival.
For info regarding 2023P000682
please contact Daniel Talmor at 617-754-3257 or
dtalmor@bidmc.harvard.edu
Title: An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications
Brief Title: Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with Oncogene Amplifications
Brief Summary: BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule
inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx).
This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety
profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355
administered as a single agent or in combination with select therapies.
For info regarding 23-708
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Digital Pill Study
Brief Title: Digital Pill Study
Brief Summary: This study assesses if a digital version (containing a chip) of the medication Abilify used to augment depression can help you with better understanding and taking this medication. This is an observational study and you must already be taking Abilify for depression and willing to use a smartphone to monitor your mental health.
For info regarding 2023P000628
please contact John Torous at
jtorous@bidmc.harvard.edu
Title: Social Media and Youth Mental Health
Brief Title: Social Media and Youth Mental Health
Brief Summary: The impact of social media on mental health is hotly debated but poorly understood. This study uses your personal smartphone to assess your use of social media, mental health symptoms, and behaviors like sleep and steps. It is two weeks long with an optional 3rd week were we ask you to refrain from social media use while still collecting data on your mental health symptoms and behaviors from your smartphone.
For info regarding 2023P001009
please contact John Torous, MD at
jtorous@bidmc.harvard.edu
Title: A phase 2 study of response-guided neoadjuvant sacituzumab govitecan (IMMU-132) in patients with localized Breast Cancer (NeoSTAR).
Brief Title: Sacituzumab Govitecan In TNBC
Brief Summary: This research study is studying to evaluate sacituzumab govitecan for individuals with
localized triple negative breast cancer (TNBC)
The names of the study drugs involved in this study is:
- Sacituzumab govitecan (SG)
- Pembrolizumab (combination therapy with SG)
For info regarding 19-578
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation
Brief Title: Studying the Effect of Denosumab on Preventing Breast Cancer in Women with a BRCA1 Germline Mutation
Brief Summary: This phase III trial compares denosumab to placebo for the prevention of breast cancer in
women with a BRCA1 germline mutation. A germline mutation is an inherited gene change
which, in the BRCA1 gene, is associated with an increased risk of breast and other
cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to
reduce the risk of bone fractures in healthy people, and to reduce new bone growths in
cancer patients whose cancer has spread to their bones. Research has shown that denosumab
may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline
mutation.
For info regarding 22-212
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Brief Title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)
Brief Summary: The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative
breast cancer that still remains after surgery and pre-surgical treatment.
For info regarding 23-399
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A single arm phase II study of ADjuvant Endocrine therapy, Pertuzumab, and Trastuzumab for patients with anatomic stage I hormone receptor-positive, HER2-positive breast cancer (ADEPT)
Brief Title: A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
Brief Summary: This research study is studying a combination of HER2-directed therapies (trastuzumab and
pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor
positive breast cancer.
The study drugs involved in this study are:
- A combination of trastuzumab and pertuzumab given as an injection under the skin
(PHESGO)
- Hormonal (endocrine) Treatment
For info regarding 20-347
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Brief Title: Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
Brief Summary: The phase III trial compares the effect of pembrolizumab to observation for the treatment
of patients with early-stage triple-negative breast cancer who achieved a pathologic
complete response after preoperative chemotherapy in combination with pembrolizumab.
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells to
grow and spread. This trial may help researchers determine if observation will result in
the same risk of cancer coming back as pembrolizumab after surgery in triple-negative
breast cancer patients who achieve pathologic complete response after preoperative
chemotherapy with pembrolizumab.
For info regarding 23-428
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 RESIDUAL DISEASE (RD), A DOUBLE-BLINDED, PHASE III RANDOMIZED TRIAL OF T-DM1 AND PLACEBO COMPARED WITH T-DM1 AND TUCATINIB
Brief Title: T-DM1 and Tucatinib Compared with T-DM1 Alone in Preventing Relapses in People with High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Brief Summary: This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it
attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2
receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work
better in preventing breast cancer from relapsing in patients with HER2 positive breast
cancer compared to T-DM1 alone.
For info regarding 21-560
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Surgical "Window-of-Opportunity" and Phase II Trial of Pembrolizumab, Olaparib and Temozolomide in Recurrent Glioblastoma
Brief Title: Surgical Pembro +/- Olaparib W TMZ for RGBM
Brief Summary: This research study is studying a combination therapy as a possible treatment for
recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite
earlier treatment.
The names of the study interventions involved in this study are/is:
- Pembrolizumab
- Olaparib
- Temozolomide (Temodar)
For info regarding 22-251
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Family-based epidemiological study of Helicobacter pylori prevalence in the United States
Brief Title: Family-based study of Helicobacter pylori prevalence
Brief Summary: The goal of this study is to evaluate the prevalence of H. pylori infection within the household. H. pylori is a bacterial infection of the stomach that can cause stomach ulcers and increase risk of stomach cancers. H. pylori infection is spread between people in close contact. We want to test family members of patients who have had H. pylori to see if they also have H. pylori infection.
For info regarding 2023P001092
please contact Brian Li at 617-297-8819 or
bli3@bidmc.harvard.edu
Title: A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients with Advanced Malignancies
Brief Title: A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Brief Summary: This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a
monotherapy in patients with metastatic or locally advanced malignancies. The study will
be conducted in 2 cohorts: Dose Escalation and Dose Expansion.
For info regarding 24-098
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A phase 2 multicenter study of the combination zanubrutinib, bendamustine, and rituximab in previously untreated Waldenström macroglobulinemia (ZEBRA Trial)
Brief Title: Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
Brief Summary: The purpose of this study is to determine the very good partial response (VGPR) or better
rate in participants with Waldenström macroglobulinemia (WM).
The names of the study drugs involved in this study are as follows: zanubrutinib,
bendamustine, and rituximab.
For info regarding 24-294
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Study of Epcoritamab in Patients with Follicular Lymphoma not Accomplishing a Complete Response with Upfront Chemoimmunotherapy
Brief Title: Epcoritamab in Patients with Follicular Lymphoma Not Accomplishing a CR with Upfront Chemoimmunotherapy
Brief Summary: This research is being done to see if epcoritamab is effective in treating follicular
lymphoma as a second line of treatment.
The name of the study drug in this research study is:
-Epcoritamab (a type of antibody)
For info regarding 24-065
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Study of Glofitamab and Obinutuzumab for first-line treatment of follicular lymphoma and marginal zone lymphoma
Brief Title: Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma
Brief Summary: The purpose of this study is to determine how effective and safe the combination of
glofitamab and obinutuzumab is in treating patients with Follicular Lymphoma (FL) and
Marginal Zone Lymphoma (MZL) who have not received other treatments for their lymphoma.
The names of the study drugs involved in this study are:
- Glofitamab (a type of immunotherapy)
- Obinutuzumab (a type of immunotherapy)
For info regarding 22-632
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 Trial Investigating Epcoritamab in Patients with Previously Treated Waldenstrom Macroglobulinemia (WM)
Brief Title: Epcoritamab in Previously Treated WM
Brief Summary: This study is being done to determine if epcoritamab can be used to treat participants
with previously treated Waldenstrom Macroglobulinemia (WM).
The names of the study drug involved in this study is:
-Epcoritamab (a type of antibody)
For info regarding 24-121
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) when Administered in the Outpatient Setting
Brief Title: A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma
Brief Summary: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood
cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing
type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of
epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell
lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy
including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic
follicular lymphoma (cFL). Adverse events will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and
R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of
epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose
is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be
enrolled in the study in approximately 80 sites in the United States of America.
Participants will receive escalating doses of subcutaneous epcoritamab, until full dose
is achieved, in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked
by medical assessments, blood tests, questionnaires and side effects.
For info regarding 23-032
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 3, Open label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an anti CD20 × anti-CD3 bispecific antibody, in Combination with CHOP (O-CHOP) versus Rituximab in combination with CHOP (R-CHOP) in Previously Untreated Participants with Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)
Brief Title: A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Brief Summary: This study is researching an experimental drug called odronextamab, referred to as study
drug, when used in combination with chemotherapy. The study is focused on patients with
diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called
"previously untreated"). Patients with DLBCL that have come back after treatment (called
"relapsed"), or have not responded to treatment (called "refractory"), can also
participate in this study.
This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B
of the study is to see how safe and tolerable the study drug in combination with
chemotherapy is and to determine the dose and schedule of the study drug to be combined
with chemotherapy in Part 2 of the study.
The aim of Part 2 of the study is to see how effective the combination of the study drug
with chemotherapy is in comparison with the combination of rituximab (the comparator
drug), and chemotherapy, the current standard of care treatment approved for DLBCL.
Standard of care means the usual medication expected and used when receiving treatment
for a condition.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug when combined with
chemotherapy
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study
drug less effective or could lead to side effects)
- The impact from the study drug on quality of life and ability to complete routine
daily activities
For info regarding 24-015
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF ODRONEXTAMAB (REGN1979), AN ANTICD20 X ANTI-CD3 BISPECIFIC ANTIBODY, VERSUS INVESTIGATOR’S CHOICE IN PREVIOUSLY UNTREATED PARTICIPANTS WITH FOLLICULAR LYMPHOMA (OLYMPIA-1)
Brief Title: A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma
Brief Summary: This study is researching an experimental drug called odronextamab, referred to as study
drug. The study is focused on participants with previously untreated follicular lymphoma
(a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized -
controlled).
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when
given alone.
The aim of Part 2 of the study is to see how the study drug works compared to rituximab
(called the "comparator drug") and chemotherapy (the current standard of care for NHL).
Standard of care means the usual medication expected and used when receiving treatment
for a condition.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study
drug less effective or could lead to side effects)
- How the study drug affects quality of life and ability to complete routine daily
activities.
For info regarding 23-612
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase II study evaluating loncastuximab tesirine in patients with previously treated Waldenström Macroglobulinemia
Brief Title: Loncastuximab Tesirine in WM
Brief Summary: This study is being done to examine the safety and effectiveness of loncastuximab
tesirine as a possible treatment for participants with Waldenström Macroglobulinemia
(WM).
The name of the study drug involved in this study is:
- Loncastuximab tesirine
For info regarding 21-622
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase II study evaluating venetoclax and pirtobrutinib in previously treated Waldenström Macroglobulinemia
Brief Title: Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia
Brief Summary: This study is being done to examine the safety and effectiveness of pirtobrutinib
combined with venetoclax as a possible treatment for participants with Waldenström
Macroglobulinemia (WM).
The names of the study drugs involved in this study are:
- Pirtobrutinib (a Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor)
- Venetoclax (a BCL2 inhibitor)
For info regarding 22-611
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies
Brief Title: Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Brief Summary: Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B
and T lymphocytes (white blood cells). The purpose of this study is to assess the safety,
pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed
or refractory (R/R) non-Hodgkin's lymphomas: third line or later of treatment (3L) +
chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large
b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma
(MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström
macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed.
ABBV-101 is an investigational drug being developed for the treatment of NHL. This study
will include a dose escalation phase to determine the maximum administered dose
(MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine
the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately
244 adult participants with multiple NHL subtypes will be enrolled in the study in sites
world wide.
In the Dose Escalation phase of the study participants will receive escalating oral doses
of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study
duration. In the dose expansion phase of the study participants receive oral ABBV-101, as
part of the approximately 88 month study duration .
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked
by medical assessments, blood tests, and side effects.
For info regarding 24-093
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2 study of Brentuximab Vedotin plus Nivolumab without Stem Cell Consolidation in Patients with Relapsed/Refractory Classical Hodgkin Lymphoma
Brief Title: Brentuximab Vedotin and Nivolumab for the Treatment of Patients with Relapsed/refractory Classical Hodgkin Lymphoma
Brief Summary: This phase II trial investigates how well brentuximab vedotin and nivolumab work in
treating patients with classical Hodgkin lymphoma that has come back after initial
treatment (relapsed) or has not responded to initial treatment (refractory). Brentuximab
vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin.
Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin
to kill them. Nivolumab is an antibody that enhances the immune system to better fight
Hodgkin lymphoma cells. Giving brentuximab vedotin and nivolumab may be able to defer
stem cell transplant treatment and spare the considerable cost and toxicity on
transplantation.
For info regarding 22-121
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A RANDOMIZED PHASE II/III TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY REGARDING CLINICAL COMPLETE RESPONSE AND DISEASE-FREE SURVIVAL IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER
Brief Title: Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation
Brief Summary: This phase II trial compares the effect of irinotecan versus oxaliplatin after
long-course chemoradiation in patients with stage II-III rectal cancer. Combination
chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and
oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX
(capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells,
either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal
cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to
higher rates of clinical complete response (with a chance of avoiding surgery) compared
to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
For info regarding 23-377
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with Xelox (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer
Brief Title: Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer
Brief Summary: This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of
IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in
patients with advanced gastric cancer.
For info regarding 23-709
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1 Study of the Polymerase Theta (POL?) Inhibitor Novobiocin in BRCA-mutant and Other DNA Damage Repair-Deficient Solid Tumors
Brief Title: Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
Brief Summary: This phase I trial tests the safety, side effects, and best dose of novobiocin in
treating cancer patients with alterations in deoxyribonucleic acid (DNA) repair genes.
Novobiocin is an antibiotic that blocks the activity of a protein called DNA polymerase
theta, which helps repair DNA that has become damaged as cells grow and divide. Cancer
cells that cannot repair their damaged DNA die. This medication may help shrink or
stabilize cancer with a mutation in DNA repair genes.
For info regarding 23-235
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants with Solid Tumors
Brief Title: A Study of XMT-1660 in Participants With Solid Tumors
Brief Summary: A Study of XMT-1660 in Solid Tumors
For info regarding 22-547
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1)
Brief Title: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
Brief Summary: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and
safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of
patients with locally advanced or metastatic HR+/HER2- breast cancer following
progression on or after CDK4/6 and aromatase inhibitor therapy.
For info regarding 23-049
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor, TOS-358, in Adult Subjects with Select Solid Tumors
Brief Title: A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors
Brief Summary: The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with
select solid tumors who meet study enrollment criteria. The main questions it aims to
answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
For info regarding 23-618
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients with Chronic Limb Threatening Ischemia (CLTI
Brief Title: SELUTION BTK
Brief Summary: This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION
SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of
peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
For info regarding 2023P000457
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: The GORE VBX FORWARD Clinical Study: A Comparison of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX) to Bare Mental Stenting for Patients with Complex Iliac Occlusive Disease
Brief Title: GORE VBX
Brief Summary: The objective of this prospective, multicenter, randomized, controlled clinical trial is
to demonstrate the superiority of the VBX Device for primary patency when compared to
bare metal stenting in complex iliac occlusive disease.
For info regarding 2023P000760
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: Neurophysiological Patterns of mindfulness meditation for Insomnia
Brief Title: Mindfulness meditation for Insomnia
Brief Summary: This is a pilot study evaluating the feasibility and acceptability of a
non-pharmacological, mind-body intervention to improve sleep quality, including a
preliminary evaluation of neurophysiological signals. The study involves 4 weeks of
guided mind-body practice at home using a smartphone app during bedtime and pre/post
in-lab sleep study visits.
For info regarding 2019P000984
please contact Ivy Ma at
yma3@bidmc.harvard.edu
Title: Mindful Steps: A Web-Based Mind-Body Exercise Intervention to Promote Physical Activity in Chronic Cardiopulmonary Disease
Brief Title: Mindful Steps 20
Brief Summary: The goal of this fully-remote randomized controlled trial is to test the efficacy of
Mindful Steps in facilitating physical activity compared to usual standard of care among
136 patients with COPD and/or HF. The main question it aims to answer is can this
intervention promote physical activity as measured by daily step counts in sedentary
patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive
either the Mindful Steps intervention or usual care for 12 months, with both arms
receiving a Walking for Health education booklet.
For info regarding 2023P000595
please contact Gloria Yeh at 617-754-1419 or
gyeh@bidmc.harvard.edu
Title: Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
Brief Title: Tai Chi for ACS
Brief Summary: This projects studies the role of tai chi exercise and wearable fitness trackers to
promote physical activity in acute coronary syndrome (ACS) survivors.
For info regarding 2022P000891
please contact Gloria Yeh at 617-754-1419 or
gyeh@bidmc.harvard.edu
Title: Advancing Cath Lab Results with FFRangio Coronary physiology Assessment: The ALL-RISE Study
Brief Title: ALL-RISE
Brief Summary: To test whether FFRangio-guided treatment is non-inferior to conventional pressure
wire-guided treatment in patients with coronary artery disease.
For info regarding 2023P000932
please contact Robert Yeh at 617-632-7653 or
ryeh@bidmc.harvard.edu
Title: Patient reported outcomes assessment in coronary and peripheral artery diseases
Brief Title: Patient reported outcomes in coronary and peripheral
Brief Summary: The Patient Reported Outcomes Assessment in Coronary and Peripheral Artery Diseases study (referred to as PAD PROMs in short) is a longitudinal study that assesses patient outcomes with treatment following peripheral artery disease (PAD) diagnosis. The study involves a baseline survey and surveys taken 1 month, 6 months, and 1 year after intervention and will ask questions relating to the participants symptoms in relation to their peripheral artery disease.
For info regarding 2016P000377
please contact Shylie Ati at
sati@bidmc.harvard.edu
Title: Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease – A Randomized Controlled Trial (Short-Cut)
Brief Title: Shockwave Lithoplasty Compared to Cutting Balloon Treatment
Brief Summary: The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized
controlled trial that is designed to compare the efficacy of cutting balloon angioplasty
vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with
moderate to severely calcified coronary arteries.
For info regarding 2024P000600
please contact Robert Yeh at 617-632-7653 or
ryeh@bidmc.harvard.edu
Title: Comeback from Long Course ADT with Relugolix and Darolutamide in Hormone-Sensitive Prostate Cancer (CLEARED)
Brief Title: Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
Brief Summary: This research study is being done to determine the rate of testosterone recovery after
completing two years of treatment with the combination of relugolix and darolutamide as
well as to assess the safety of the drugs when administered in combination.
The names of the drugs in this study are:
- Relugolix (a type of gonadotropin-releasing hormone receptor antagonist)
- Darolutamide (a type of androgen receptor antagonist)
For info regarding 24-217
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana
Brief Title: Tshireletso
Brief Summary: The goal of this this hybrid safety/implementation study is to evaluate whether using
long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and
safe in post-partum people who are breastfeeding. The main question[s] it aims to answer
are:
- Will CAB-LA injections work well as a way to prevent HIV infection in post-partum
people?
- Will CAB-LA injections be safe in post-partum people and their infants who will be
breastfeeding?
Participants without HIV who are admitted to the maternity ward after having delivered a
baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive
their first dose (injection) at the maternity ward and their follow up doses (injections)
at their local clinic when they come for routine post-partum and pediatric care.
Participants and their infants will be followed in the study for 24 months. We will be
following how many people come on-time for their CAB-LA injections, how often they keep
coming back, and the reasons they continue (or stop) these injections. We will also test
people for HIV at all of their visits to see how many people get HIV during the study. We
will also measure the levels of the medication in the blood of the post-partum people and
their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see
if their is any impact of CAB-LA on the health of the post-partum person or their
infants.
For info regarding 2023P000415
please contact Rebecca Zash at 617-632-7706 or
rzash@bidmc.harvard.edu