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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
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
pembrolizumab
Administered as an IV infusion every 3 weeks (Q3W)
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