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: 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: 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: 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: Mind Body Back Pain Study
Brief Title: treatment of Chronic Pain
Brief Summary: The goal of this study is to determine if a mind-body intervention can help people
suffering from chronic back pain. The study is a randomized, partially blinded trial
examining the effectiveness of a mind body intervention in reducing disability from back
pain and alleviating back pain in participants as compared to usual care and an active
control (second mind body intervention). The investigators will secondarily investigate
whether the intervention alleviates anxiety related to the pain and other quality of life
parameters.
For info regarding 2020P000147
please contact Michael Donnino, MD at 617-754-2884 or
mindbodystudy@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: Clinical Utility Study to Determine Impact of PanCystPro Assay on Physician Decision-Making in the Management of Pancreatic Cystic Lesions (PanAMP)
Brief Title: PanAMP
For info regarding 25-395
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@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: 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 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: 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: 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: An Open-label, Intra-participant Dose Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Immune Thrombocytopenia
Brief Title: Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia
Brief Summary: The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well
patients respond to this investigational treatment. NVG-2089 is a new drug that is being
developed for treating patients with ITP. NVG-2089 is designed to mimic the effects of a
protein called IVIg. NVG-2089 is designed to help the immune system by attaching
(binding) to certain receptors in the body and activating them, which helps reduce
inflammation and supports how the immune system works.
For info regarding 25-417
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: AN OPEN-LABEL, PHASE I/II STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ENGLUMAFUSP ALFA (RO7227166, A CD19 TARGETED 4-1BB LIGAND) IN COMBINATION WITH OBINUTUZUMAB AND IN COMBINATION WITH GLOFITAMAB FOLLOWING A PRE-TREATMENT DOSE OF OBINUTUZUMAB ADMINISTERED IN PARTICIPANTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA
Brief Title: A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Brief Summary: This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety,
tolerability, and efficacy of englumafusp alfa (RO7227166) in participants with
relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). Englumafusp alfa will be
administered by intravenous (IV) infusion in combination with obinutuzumab and in
combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be
administered up to seven days prior to the first administration of englumafusp alfa and
seven days prior to the first administration of glofitamab. This entry-into-human study
is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage
(Part III).
For info regarding 25-142
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Evaluating Platelet Drp1 Phosphorylation in Patients With Heparin Induced Thrombocytopenia
Brief Title: Evaluating Platelet Drp1 Phosphorylation in Patients With HIT
For info regarding 25-085
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase II study of Odronextamab in Treatment Naive Patients with Low Tumor Volume Advanced Stage Follicular Lymphoma
Brief Title: Odronextamab in Low Tumor Volume Advanced FL
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of treating
previously untreated Follicular Lymphoma (FL) with odronextamab.
The name of the study drug in this research study is:
-Odronextamab (a type of monoclonal antibody)
For info regarding 25-008
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: 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 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 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 1 Study to Evaluate the Safety and Tolerability of GS 5319 in Adults With MTAP-deleted Advanced Solid Tumors
Brief Title: Study of GS-5319 in Adults With Solid Tumors
Brief Summary: The goal of this clinical study is to learn more about the study drug, GS-5319, its
dosing, safety and tolerability in adults with solid tumors, where the participants show
a specific gene alteration in the tumor. The gene helps produce methylthioadenosine
phosphorylase (MTAP) enzyme. MTAP enzyme helps in normal growth of cells.
The primary objectives of the study are to assess the safety and tolerability of GS-5319
in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid
tumors and to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD)
and/or the recommended dose for expansion (RDE).
For info regarding 25-506
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A PHASE 1/2, OPEN-LABEL, MULTICENTER, DOSE-ESCALATION, AND DOSE-OPTIMIZATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND ACTIVITY OF EIK1004 (IMP1707) AS MONOTHERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS.
Brief Title: A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
Brief Summary: This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004
(IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian
cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with
deleterious/suspected deleterious mutations of select homologous recombination repair
(HRR) genes.
Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004
(IMP1707) Phase 1/Phase 2
For info regarding 25-273
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase 1 study of ACR-2316 in subjects with advanced solid tumors
Brief Title: Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
Brief Summary: This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for
the treatment of subjects with specific, histologically confirmed, locally advanced,
recurrent or metastatic solid tumors.
For info regarding 25-245
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: MagnetisMM-32: A Study Comparing the Study Medicine called Elranatamab versus Elotuzumab, Pomalidomide, Dexamethasone (EPd) or Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in People With Multiple Myeloma That Has Come Back After Prior Treatment(s)
Brief Title: MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
Brief Summary: The purpose of this study is to learn about the study medicine called elranatamab.This
study aims to compare elranatamab to other medicines for the treatment of MM (a type of
cancer).
This study is seeking participants who:
- Are 18 years of age or older and have MM.
- Have received treatments before for MM.
- Have MM that has returned or not responded to their most recent treatment.
Half of the participants will receive elranatamab. The other half of participants will
receive a combination therapy selected by the study doctor. The selected combination
therapy will include 2 to 3 different medicines commonly used to treat MM.
Elranatamab will be given as a shot under the skin at the study clinic about once a week.
This may change to a smaller number of shots later in the study.
The medicines in the combination therapy will be taken by mouth (at home or at the study
clinic) AND will be given either as:
- a shot under the skin at the study clinic
- through a needle in the vein at the study clinic The number of times these medicines
will be taken depends on what combination therapy the study doctor selects.
Participants may continue to receive elranatamab or a combination therapy until their MM
is no longer responding. The study team will see how each participant is doing with the
study treatment during regular visits at the study clinic. The study team will continue
to follow-up with participants after study treatment with telephone contacts (or visits).
The study will compare the experiences of people receiving elranatamab to those people
receiving a combination therapy. This will help learn about the safety and how effective
elranatamab is.
For info regarding 25-051
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants with Advanced Solid Malignancies
Brief Title: A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
Brief Summary: The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety
and dosing of COM503 when given alone or in combination with zimberelimab in participants
with advanced solid tumors.
The primary objectives of this study are:
- To assess the safety and tolerability of COM503 as monotherapy and COM503 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 COM503 as monotherapy and in
combination with zimberelimab in participants with advanced solid tumors.
For info regarding 24-694
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 doses of GLPG5101 work best with the least number of
side effects.
- In the second phase, participants will receive the selected dose(s) based on the
results in the first phase.
For info regarding 24-603
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes
Brief Title: A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants
with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1,
or NUP98 genes.
For info regarding 24-577
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: 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 I/II study of AZD3470 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Relapsed/Refractory Haematologic Malignancies (PRIMAVERA)
Brief Title: AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.
Brief Summary: This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy
following oral administration of AZD3470 as a monotherapy, and in combination with other
anticancer agents in participants with haematologic malignancies.
For info regarding 24-433
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Chemo4METPANC : A Phase 2 study with combination CHEmotherapy (Gemcitabine and Nab-Paclitaxel), cheMOkine (C-X-C) motif receptor 4 inhibitor (Motixafortide), and immune checkpoint blockade (Cemiplimab) in METastatic treatment naïve PANCreas adenocarcinoma.
Brief Title: Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Brief Summary: The purpose of this study is to determine if combination treatment with cemiplimab,
motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the
tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists
of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is
standard treatment for patients with pancreatic adenocarcinoma. Participants will receive
immunotherapy (cemiplimab) which activates the body's immune system to attack cancer
cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas
cancer. Participants will also receive Motixafortide, a new medication which has shown in
the laboratory to help immunotherapy work better. Motixafortide has been tested together
with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal
Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been
tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and
nab-paclitaxel) which participants will receive and is being tested in this clinical
trial.
For info regarding 24-417
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 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 Participants With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
Brief Summary: The purpose of this study is to assess the safety 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: 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: 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, efficacy and pharmacokinetics (PK)
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 phase 1 study to investigate PF-08046050 (SGN-CEACAM5C) in adults with advanced solid tumors
Brief Title: A Study of 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.
Participants in this study must have cancer that has come back or did not get better with
treatment. Participants 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 has 5 different study 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. Part D of the study, together with information from Parts A and B, will find out
how much PF-08046050 should be given to participants in combination with bevacizumab.
Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in
combination with bevacizumab and if it works to treat a certain solid tumor.
For info regarding 24-125
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@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 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 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 1-2 dose-escalation and expansion study of ST316 in subjects with selected advanced unresectable and metastatic solid tumors
Brief Title: A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
Brief Summary: This is an open-label, two-part, phase 1-2 study designed to determine the safety,
tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316
administered IV in subjects with selected advanced solid tumors likely to harbor
abnormalities of the WNT/ß-catenin signaling pathway. The study consists of two phases: a
phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
For info regarding 24-054
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: 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: Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
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 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (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 Denikitug (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: 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: Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
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 Single Arm Phase 2 Study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic biliary tract cancer
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: 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 Phase 1 Study of PF-08046040/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 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 1/2 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 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: 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: 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: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson’s Disease (LRRK2-PD)
Brief Title: Safety and Pharmacodynamic Effects of BIIB122 in Participant
Brief Summary: This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled,
parallel-group study, followed by an OLE, is designed to evaluate the safety,
tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD.
LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or
homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
For info regarding 2024P000639
please contact Hannah Babcock at 617-667-9890 or
hbabcock@bidmc.harvard.edu
Title: A Proof of Concept Trial of a Sirtuin-NAD+ Activator in Alzheimer’s Disease
Brief Title: MIB - AD
Brief Summary: The investigational product, MIB-626, which is not FDA approved, is being studied for its ability to treat or prevent Alzheimers Disease. As a first step we want to find out if MIB-626 can get into the brain and increase the levels of a related chemical in parts of the brain that are affected in Alzheimers Disease. We also want to make sure that MIB-626 is safe to take without causing too many side effects.
For info regarding 2023C001160
please contact Daniel Press at 617-667-0459 or
dpress@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: Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus (STRIDE)
Brief Title: STRIDE E-Shunt Study
Brief Summary: Prospective, multi-center, randomized, controlled trial of the eShunt System in the
treatment of patients with normal pressure hydrocephalus.
For info regarding 2025P000157
please contact Christopher Ogilvy at 617-111-1111 or
cogilvy@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: 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: 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: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)
Brief Title: A Randomized, Placebo-Controlled, Study with Pirfenidone Sol
Brief Summary: A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and
efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of
care in participants with PPF over 52 weeks.
For info regarding 2024P000407
please contact Sean Levy at 617-726-8554 or
sdlevy@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: Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma
Brief Title: Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery
Brief Summary: To determine the safety of moderately hypofractionated radiation in the treatment of
primary and locally recurrent RPS, based on the evaluation of acute radiation-related
toxicity profile of each participant (30-day radiation toxicity)
For info regarding 24-450
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@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: 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: Clinical Trial of Approaches to Prostate Cancer Surgery
Brief Title: Clinical Trial of Approaches to Prostate Cancer Surgery
Brief Summary: This is a prospective, randomized controlled trial to compare cancer control and
health-related quality of life following pelvic fascia-sparing radical prostatectomy
versus standard radical prostatectomy.
The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have
similar cancer control (primary outcome) and sexual function outcomes; and significantly
better urinary function, penile shortening/deformity and inguinal hernia risks as
compared to radical prostatectomy.
For info regarding 24-693
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 surveillance 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: 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