Treatment Clinical Studies

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.

PI: Roger Laham, MD

Group: Cardiovascular Medicine

Study Start: 7/7/2020

End: 1/1/2029

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04226547

For info regarding 2021P000891 please contact Jenifer Kaufman at 617-632-8956 or cardscto@bidmc.harvard.edu

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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).

PI: Arthur Garan, MD

Group: Cardiovascular Medicine

Study Start: 12/21/2020

End: 12/31/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04331769

For info regarding 2020P000833 please contact Jenifer Kaufman at 617-632-8956 or cardscto@bidmc.harvard.edu

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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)

PI: Roger Laham, MD

Group: Cardiovascular Medicine

Study Start: 11/30/2018

End: 6/30/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT03706833

For info regarding 2018P000760 please contact Jenifer Kaufman at 617-632-8956 or cardscto@bidmc.harvard.edu

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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 Women With HR+ HER2- Breast Cancer

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?

PI: Antonio Giordano, MD

Group: Dana Farber Cancer Institute

Study Start: 2/15/2023

End: 12/1/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05683418

For info regarding 23-618 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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

PI: Antonio Giordano, MD

Group: Dana Farber Cancer Institute

Study Start: 8/15/2022

End: 12/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05377996

For info regarding 22-547 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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 300 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.

PI: Alexandra Kimball, MD

Group: Dermatology

Study Start: 6/21/2023

End: 3/1/2028

Gender: All

Age Range: 12 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05889182

For info regarding 2023P000553 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu

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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.

PI: Andrew Yee

Group: Exeter Hospital

Study Start: 5/8/2018

End: 3/21/2022

Gender: All

Age Range: 18 Years to 101 Years

Recruit Healthy Volunteers: No

ID: NCT03489525

For info regarding 18-165 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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

PI: Mandeep Sawhney, MD

Group: Gastroenterology

Gender:

Age Range: to

Recruit Healthy Volunteers: No

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.

PI: Alan Bonder, MD

Group: Gastroenterology

Study Start: 9/7/2023

End: 8/1/2030

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06051617

For info regarding 2023P000565 please contact Alan Bonder at 617-632-1070 or abonder@bidmc.harvard.edu

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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.

PI: Alan Bonder, MD

Group: Gastroenterology

Study Start: 9/7/2023

End: 8/1/2030

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06051617

For info regarding 2023P000565 please contact Liver Center Trials Office at 617-632-1118 or abonder@bidmc.harvard.edu

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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.

PI: Alan Bonder, MD

Group: Gastroenterology

Study Start: 9/22/2021

End: 4/1/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05050136

For info regarding 2021P000960 please contact Julie Shea at 617-632-1125 or jmshea@bidmc.harvard.edu

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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.

PI: Alan Bonder, MD

Group: Gastroenterology

Study Start: 9/22/2021

End: 4/1/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05050136

For info regarding 2021P000960 please contact Liver Center Trials Office at 617-632-1118 or abonder@bidmc.harvard.edu

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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.

PI: Alan Bonder, MD

Group: Gastroenterology

Study Start: 12/18/2020

End: 6/1/2026

Gender: All

Age Range: 12 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04663308

For info regarding 2021P000450 please contact Julie Shea at 167-632-1125 or jmshea@bidmc.harvard.edu

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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.

PI: Alan Bonder, MD

Group: Gastroenterology

Study Start: 12/18/2020

End: 6/1/2026

Gender: All

Age Range: 12 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04663308

For info regarding 2021P000450 please contact Liver Center Trials Office at 617-632-1118 or abonder@bidmc.harvard.edu

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Title: A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies against FXI, versus Apixaban in Participants with Atrial Fibrillation (ROXI-ATLAS)

Brief Title: Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Brief Summary: This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots. The study is looking at several other research questions, including: - What side effects may happen from taking REGN7508 or REGN9933 - How well do the study drugs reduce the risk of having a stroke - How much of REGN7508 or REGN9933 is in the blood at different times - Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

PI: Rushad Patell, MD

Group: Hematologic Malignancies

Study Start: 10/20/2025

End: 2/9/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT07175428

For info regarding 25-764 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 2A, Open-Label, Multi-Center Study of Tafasitamab in Adult Participants with Primary Autoimmune Blood Cell Disorders

Brief Title: Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

Brief Summary: This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.

PI: Rushad Patell, MD

Group: Hematologic Malignancies

Study Start: 12/29/2025

End: 9/23/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT07104565

For info regarding 25-736 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 2, single-arm, open-label study evaluating subcutaneous isatuximab, administered by an on-body delivery system, in combination with weekly carfilzomib and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma (RRMM)

Brief Title: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Brief Summary: The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.

PI: David Avigan, MD

Group: Hematologic Malignancies

Study Start: 3/17/2025

End: 1/8/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06356571

For info regarding 25-461 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Rushad Patell, MD

Group: Hematologic Malignancies

Study Start: 9/30/2025

End: 6/30/2027

Gender: All

Age Range: 18 Years to 80 Years

Recruit Healthy Volunteers: No

ID: NCT07095127

For info regarding 25-417 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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).

PI: Gottfried von Keudell, MD,PhD

Group: Hematologic Malignancies

Study Start: 8/13/2019

End: 3/31/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04077723

For info regarding 25-142 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: Evaluating Platelet Drp1 Phosphorylation in Patients With Heparin Induced Thrombocytopenia

Brief Title: Evaluating Platelet Drp1 Phosphorylation in Patients With HIT

PI: Rushad Patell, MD

Group: Hematologic Malignancies

Gender:

Age Range: to

Recruit Healthy Volunteers: No

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)

PI: Gottfried von Keudell, MD,PhD

Group: Hematologic Malignancies

Study Start: 9/8/2025

End: 1/2/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT07128641

For info regarding 25-008 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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: RRMM (MMRC-099)

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.

PI: David Avigan, MD

Group: Hematologic Malignancies

Study Start: 11/17/2024

End: 7/31/2029

Gender: All

Age Range: 18 Years to 99 Years

Recruit Healthy Volunteers: No

ID: NCT06171685

For info regarding 24-476 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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)

PI: David Avigan, MD

Group: Hematologic Malignancies

Study Start: 1/31/2025

End: 9/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06799026

For info regarding 24-439 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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)

PI: Gottfried von Keudell, MD,PhD

Group: Hematologic Malignancies

Study Start: 12/6/2024

End: 4/30/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06510491

For info regarding 24-121 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: ADAPTiON: Apixaban Dose Adjustment in Patient with Thrombocytopenia in ONcology

Brief Title: Apixaban in Thrombocytopenia

Brief Summary: This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The name of the study drug involved in this study is: -Apixiban (a type of anticoagulant)

PI: Rushad Patell, MD

Group: Hematologic Malignancies

Study Start: 2/28/2025

End: 7/1/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06886516

For info regarding 24-110 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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)

PI: Gottfried von Keudell, MD,PhD

Group: Hematologic Malignancies

Study Start: 11/20/2024

End: 5/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06510361

For info regarding 24-065 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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 (Odro-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 Adult 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

PI: Gottfried von Keudell, MD,PhD

Group: Hematologic Malignancies

Study Start: 12/13/2023

End: 3/30/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06091865

For info regarding 24-015 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

Brief Title: Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma

Brief Summary: The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL). The names of the study drugs involved in this study are: - Venetoclax (a type of inhibitor) - Rituximab (a type of antibody)

PI: Gottfried von Keudell, MD,PhD

Group: Hematologic Malignancies

Study Start: 2/11/2026

End: 10/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06510309

For info regarding 23-711 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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).

PI: David Avigan, MD

Group: Hematologic Malignancies

Study Start: 1/5/2022

End: 8/22/2024

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05032820

For info regarding 21-673 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: David Avigan, MD

Group: Hematologic Malignancies

Study Start: 2/1/2012

End: 12/1/2030

Gender: All

Age Range: N/A to 100 Years

Recruit Healthy Volunteers: No

ID: NCT01656603

For info regarding 12-223 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Brief Title: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

Brief Summary: The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced microsatellite stable (MSS) colorectal cancer (CRC). The primary objective of this study is to assess the effect of DEN as monotherapy and in combination with nivolumab (NIVO) or trifluridine-tipiracil (FTD-TPI) and bevacizumab (BVZ) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1).

PI: Bruno Bockorny, MD

Group: Hematology Oncology

Study Start: 5/19/2026

End: 12/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT07527858

For info regarding 26-123 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy

Brief Title: A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Brief Summary: The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

PI: Malgorzata McMasters, MD

Group: Hematology Oncology

Study Start: 6/4/2025

End: 6/22/2029

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06852222

For info regarding 25-649 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 1, First in Human Study of adoptive T cell therapy with T cells stimulated by dendritic cell (DC)/tumor fusions in combination with decitabine and venetoclax in patients with acute myeloid leukemia (AML)

Brief Title: Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML

Brief Summary: The goal of this research study is to test if the combination of a new T cell therapy (dendritic cell (DC) / acute myeloid leukemia (AML) primed T cells), vaccine (DC/AML fusion vaccine) and standard of care decitabine and venetoclax is feasible and safe and effective for treatment of acute myeloid leukemia (AML). The names of the study drugs involved in this study are: - DC/AML fusion vaccine (immune cell vaccine) - Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone) - DC/AML Primed T cells (immune cells) - Decitabine (a type of chemotherapy drug) - Venetoclax (a type of antineoplastic agent)

PI: Jessica Liegel, MD

Group: Hematology Oncology

Study Start: 2/12/2026

End: 10/1/2027

Gender: All

Age Range: N/A to 100 Years

Recruit Healthy Volunteers: No

ID: NCT07374029

For info regarding 25-593 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Brief Title: Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Brief Summary: This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

PI: Jessica Liegel, MD

Group: Hematology Oncology

Study Start: 9/8/2022

End: 4/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05243797

For info regarding 25-576 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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).

PI: Bruno Bockorny, MD

Group: Hematology Oncology

Study Start: 8/28/2025

End: 5/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT07128303

For info regarding 25-506 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Brief Title: Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Brief Summary: The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

PI: Malgorzata McMasters, MD

Group: Hematology Oncology

Study Start: 2/22/2024

End: 8/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06001788

For info regarding 25-470 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 2 study to investigate the efficacy and safety of Acoustic Cluster Therapy with modified FOLFIRINOX in patients with locally advanced pancreatic cancer

Brief Title: Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

Brief Summary: The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.

PI: Andrea Bullock, MD

Group: Hematology Oncology

Study Start: 6/19/2025

End: 12/15/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06850623

For info regarding 25-278 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: MM1OA-EA02, A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial

Brief Title: Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

Brief Summary: This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.

PI: Malgorzata McMasters, MD

Group: Hematology Oncology

Study Start: 9/27/2024

End: 5/15/2029

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06317649

For info regarding 25-152 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by myeloMATCH; A myeloMATCH Clinical Trial

Brief Title: Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

Brief Summary: This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal 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. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

PI: Malgorzata McMasters, MD

Group: Hematology Oncology

Study Start: 9/25/2024

End: 3/31/2027

Gender: All

Age Range: 18 Years to 59 Years

Recruit Healthy Volunteers: No

ID: NCT05554406

For info regarding 25-077 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma (ACTengine® IMA203-301)

Brief Title: SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Brief Summary: This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma. For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/

PI: Hollis Viray, MD

Group: Hematology Oncology

Study Start: 1/14/2025

End: 1/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06743126

For info regarding 25-046 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Bruno Bockorny, MD

Group: Hematology Oncology

Study Start: 1/7/2025

End: 11/22/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06759649

For info regarding 24-694 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Malgorzata McMasters, MD

Group: Hematology Oncology

Study Start: 5/21/2024

End: 2/1/2027

Gender: All

Age Range: 18 Years to 75 Years

Recruit Healthy Volunteers: No

ID: NCT06226571

For info regarding 24-577 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: PRIMAVERA: A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of AZD3470, a PRMT5 Inhibitor as Monotherapy or in Combination with Anticancer Agent(s) in Participants with Relapsed/Refractory Haematologic Malignancies

Brief Title: AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With 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.

PI: Matthew Weinstock, MD

Group: Hematology Oncology

Study Start: 1/23/2024

End: 4/30/2029

Gender: All

Age Range: 15 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06137144

For info regarding 24-433 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Bruno Bockorny, MD

Group: Hematology Oncology

Study Start: 11/9/2020

End: 6/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04543071

For info regarding 24-417 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Bruno Bockorny, MD

Group: Hematology Oncology

Study Start: 7/26/2024

End: 6/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06532565

For info regarding 24-378 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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 and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.

PI: Andrea Bullock, MD

Group: Hematology Oncology

Study Start: 11/20/2023

End: 9/12/2029

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06131840

For info regarding 24-125 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Hollis Viray, MD

Group: Hematology Oncology

Study Start: 3/19/2024

End: 12/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06150664

For info regarding 24-098 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Jon Arnason, MD

Group: Hematology Oncology

Study Start: 12/28/2023

End: 6/1/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05905328

For info regarding 24-094 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications

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 phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.

PI: Hollis Viray, MD

Group: Hematology Oncology

Study Start: 1/25/2022

End: 1/1/2029

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05098132

For info regarding 22-173 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Bruno Bockorny, MD

Group: Hematology Oncology

Study Start: 8/18/2021

End: 12/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05007782

For info regarding 22-070 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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)

PI: Andrea Bullock, MD

Group: Hematology Oncology

Study Start: 2/13/2024

End: 12/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05655949

For info regarding 21-541 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Deepa Rangachari, MD

Group: Hematology Oncology

Study Start: 6/25/2020

End: 4/12/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04295863

For info regarding 21-069 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Malgorzata McMasters, MD

Group: Hematology Oncology

Study Start: 8/7/2020

End: 7/4/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT04227847

For info regarding 20-191 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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

PI: Malgorzata McMasters, MD

Group: Hematology Oncology

Study Start: 7/24/2018

End: 11/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT03595917

For info regarding 18-170 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Adnan Majid, MD

Group: Intervent Pulmonary Surgery

Study Start: 8/1/2021

End: 8/1/2026

Gender: All

Age Range: 40 Years to 75 Years

Recruit Healthy Volunteers: No

ID: NCT04801108

For info regarding 2021P000049 please contact Christine Conley at 617-632-8386 or cconley@bidmc.harvard.edu

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Title: Phase I study of vaccination with DC/MM fusion cells in combination with BCMA directed CAR-T cell therapy in relapsed/refractory multiple myeloma

Brief Title: DC/MM Fusion Vaccine With BCMA CAR-T in R/R MM

Brief Summary: This study is to evaluate the safety and effectiveness of dendritic cell DC/MM fusion vaccine in combination with standard of care B-cell maturation antigen (BCMA) CAR-T cell therapy in participants with relapsed/refractory multiple myeloma. The names of the study drugs involved in this study are: - DC/MM fusion vaccine (a type of personalized cancer vaccine) - Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)

PI: Jacalyn Rosenblatt, MD

Group: Medical Oncology

Study Start: 1/30/2026

End: 3/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT07377435

For info regarding 25-799 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Phase 2, randomized, open-label, active-controlled study of JNJ-90301900 in combination with chemoradiation followed by durvalumab in locally advanced and unresectable Stage III non-small cell lung cancer

Brief Title: A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

Brief Summary: The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.

PI: Daniel Costa, MD

Group: Medical Oncology

Study Start: 12/6/2024

End: 12/31/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06667908

For info regarding 25-717 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A Randomized Phase 2 Trial of Nivolumab, Relatlimab plus Ipilimumab vs. Nivolumab plus Ipilimumab in first-line advanced renal cell carcinoma (RCC)

Brief Title: A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

Brief Summary: This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

PI: David Mcdermott, MD

Group: Medical Oncology

Study Start: 3/20/2025

End: 12/15/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06708949

For info regarding 25-343 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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

PI: Gerburg Wulf, MD

Group: Medical Oncology

Study Start: 4/30/2025

End: 12/1/2028

Gender: All

Age Range: 18 Years to 89 Years

Recruit Healthy Volunteers: No

ID: NCT06907043

For info regarding 25-273 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Gerburg Wulf, MD

Group: Medical Oncology

Study Start: 10/8/2024

End: 8/12/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06667141

For info regarding 25-245 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

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.

PI: Jacalyn Rosenblatt, MD

Group: Medical Oncology

Study Start: 2/8/2024

End: 8/30/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06152575

For info regarding 25-051 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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Title: Phase II study of belantamab mafodotin in combination with carfilzomib, pomalidomide, and dexamethasone (KPd) in patients with relapsed multiple myeloma

Brief Title: Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma

Brief Summary: Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy. Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.

PI: Jacalyn Rosenblatt, MD

Group: Medical Oncology

Study Start: 5/30/2023

End: 7/1/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05789303

For info regarding 24-199 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Daniel Costa, MD

Group: Medical Oncology

Study Start: 7/31/2023

End: 8/31/2028

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05967689

For info regarding 24-186 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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

PI: David Mcdermott, MD

Group: Medical Oncology

Study Start: 9/14/2016

End: 3/27/2023

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT02799095

For info regarding 16-229 please contact Immuno-Oncology Group Group Box BIDMC at Immuno-OncologyTrials@bidmc.harvard.edu

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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.

PI: Bradley Denker, MD

Group: Nephrology

Study Start: 3/30/2022

End: 6/2/2028

Gender: All

Age Range: 10 Years to 65 Years

Recruit Healthy Volunteers: No

ID: NCT05312879

For info regarding 2022P000526 please contact Liz Roy at (617) 975-8684 or eroy2@bidmc.harvard.edu

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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.

PI: Ludy Shih, MD

Group: Neurology

Study Start: 10/24/2024

End: 3/1/2027

Gender: All

Age Range: 30 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06602193

For info regarding 2024P000639 please contact Hannah Babcock at 617-667-9890 or hbabcock@bidmc.harvard.edu

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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.

PI: Christopher Ogilvy, MD

Group: Neurosurgery

Study Start: 11/26/2024

End: 12/1/2026

Gender: All

Age Range: 60 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06498960

For info regarding 2025P000157 please contact Christopher Ogilvy at 617-111-1111 or cogilvy@bidmc.harvard.edu

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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.

PI: Megan Anderson, MD

Group: Orthopedic Surgery

Study Start: 5/3/2018

End: 1/1/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT03295981

For info regarding 21-396 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Raquelle Mesholam-Gately, PhD

Group: Psychiatry

Study Start: 9/2/2022

End: 5/31/2025

Gender: All

Age Range: 18 Years to 65 Years

Recruit Healthy Volunteers: No

ID: NCT05282186

For info regarding 2022P000199 please contact Sunny Lee at 617-754-1203 or slee54@bidmc.harvard.edu

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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.

PI: Prerna Mota, MD

Group: Pulmonary & Critical Care

Study Start: 4/3/2024

End: 6/1/2027

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06329401

For info regarding 2024P000407 please contact Sean Levy at 617-726-8554 or sdlevy@bidmc.harvard.edu

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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.

PI: Prerna Mota, MD

Group: Pulmonary & Critical Care

Study Start: 7/29/2022

End: 10/13/2026

Gender: All

Age Range: 40 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05389215

For info regarding 2023P000113 please contact Clinical Research Center at 617-975-7600 or crc@bidmc.harvard.edu

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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)

PI: Daniel Schmidt, MD,PhD

Group: Radiation Oncology

Study Start: 5/29/2025

End: 11/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06812052

For info regarding 24-450 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Irving Kaplan, MD

Group: Radiation Oncology

Study Start: 7/1/2013

End: 1/1/2025

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT01890590

For info regarding 12-235 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Peter Chang, MD

Group: Urologic Surgery

Study Start: 5/15/2023

End: 7/1/2028

Gender: Male

Age Range: 40 Years to 80 Years

Recruit Healthy Volunteers: No

ID: NCT05155501

For info regarding 24-693 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Boris Gershman, MD

Group: Urologic Surgery

Study Start: 12/14/2023

End: 6/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT06111235

For info regarding 24-247 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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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.

PI: Boris Gershman, MD

Group: Urologic Surgery

Study Start: 7/11/2023

End: 5/1/2026

Gender: All

Age Range: 18 Years to 100 Years

Recruit Healthy Volunteers: No

ID: NCT05710848

For info regarding 23-164 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu

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