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)
Stopped early · Phase 1/Phase 2
Conditions studied: Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
In brief
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.
Key facts
- Study ID
- NCT03598608
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 137
- Starts
- 2018-10-17
- Expected to finish
- 2026-01-28
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has measurable disease, defined as ≥1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis
- Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
You may not qualify if…
- Has known clinically active central nervous system (CNS) involvement
- Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
- Has received chimeric antigen receptors (CAR)-T-cell therapy for cHL and DLBCL Cohorts
- Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment
- Has ≥Grade 2 non-hematological residual toxicities from prior therapy
- Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to agents administered ≥4 weeks earlier
- Has received a live vaccine within 30 days prior to first dose of study treatment. Administration of killed vaccines are allowed
- Has received an investigational agent or used an investigational device within 4 weeks prior to intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
- Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has an active infection requiring intravenous systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has known, active hepatitis B or hepatitis C infection
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
- Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years
Where it is running
- 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
Full record on ClinicalTrials.gov
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