Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
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
Study ID: NCT03598608
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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), Koeln, Nordrhein-Westfalen, Germany
Universitaetsklinikum Leipzig AOeR ( Site 0327), Leipzig, Sachsen, 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
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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