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TERMINATED
NCT03598608
PHASE1/PHASE2

Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: * classical Hodgkin lymphoma (cHL) * diffuse large B-cell lymphoma (DLBCL) * indolent non-Hodgkin lymphoma (iNHL) This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design. The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities. There is no primary hypothesis for this study.

Official title: A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

137

Start Date

2018-10-17

Completion Date

2026-01-28

Last Updated

2026-07-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

pembrolizumab

Administered as an IV infusion every 3 weeks (Q3W)

BIOLOGICAL

Favezelimab

Administered as an IV infusion Q3W

Locations (25)

Banner MD Anderson Cancer Center ( Site 0020)

Gilbert, Arizona, United States

City of Hope ( Site 0001)

Duarte, California, United States

Ronald Reagan UCLA Medical Center (Radiological Sciences) ( Site 0007)

Los Angeles, California, United States

Pacific Cancer Care ( Site 0006)

Monterey, California, United States

University of California San Francisco ( Site 0023)

San Francisco, California, United States

Dana Farber Cancer Institute ( Site 0002)

Boston, Massachusetts, United States

Fox Chase Cancer Center ( Site 0019)

Philadelphia, Pennsylvania, United States

Texas Oncology-Austin Midtown ( Site 8002)

Austin, Texas, United States

Concord Repatriation & General Hospital ( Site 0203)

Concord, New South Wales, Australia

Princess Alexandra Hospital ( Site 0204)

Woollongabba, Queensland, Australia

Monash Health ( Site 0201)

Clayton, Victoria, Australia

St Vincent s Hospital (Melbourne) Limited ( Site 0202)

Fitzroy, Victoria, Australia

BC Cancer ( Site 0107)

Vancouver, British Columbia, Canada

CancerCare Manitoba ( Site 0101)

Winnipeg, Manitoba, Canada

Princess Margaret Cancer Centre ( Site 0100)

Toronto, Ontario, Canada

Jewish General Hospital ( Site 0105)

Montreal, Quebec, Canada

U. klinikum Koeln AOER ( Site 0326)

Cologne, North Rhine-Westphalia, Germany

Universitaetsklinikum Leipzig AOeR ( Site 0327)

Leipzig, Saxony, Germany

Rambam Medical Center ( Site 0382)

Haifa, Israel

Hadassah Ein Karem Jerusalem ( Site 0383)

Jerusalem, Israel

Chaim Sheba Medical Center. ( Site 0380)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0381)

Tel Aviv, Israel

A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0351)

Bologna, Emilia-Romagna, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0354)

Meldola, Forli-Cesena, Italy

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0352)

Rozzano, Milano, Italy