NCT03598608TerminatedPhase 1/2
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)
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 16 Jul 2018
- Start date
- 17 Oct 2018
- Primary completion date
- 28 Jan 2026
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT03598608
- EU CT number
- 2023-503587-17-00
- EudraCT number
- 2018-001461-16
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years
Other illness
- 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
Lab values
- Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
Other
- Has known clinically active central nervous system (CNS) involvement
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health (Site 0201) Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Concord Repatriation & General Hospital (Site 0203) Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| St Vincent s Hospital (Melbourne) Limited (Site 0202) Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Princess Alexandra Hospital (Site 0204) Coordinator of this site? Confirm its status | Woollongabba | Australia | Unknown status |
| Jewish General Hospital (Site 0105) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Cancer Centre (Site 0100) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Cancer (Site 0107) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| CancerCare Manitoba (Site 0101) Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| U. klinikum Koeln AOER (Site 0326) Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitaetsklinikum Leipzig AOeR (Site 0327) Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Rambam Medical Center (Site 0382) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Ein Karem Jerusalem (Site 0383) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Chaim Sheba Medical Center. (Site 0380) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Center (Site 0381) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| A.O. Universitaria Policlinico S. Orsola-Malpighi (Site 0351) Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Site 0354) Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Humanitas-U.O di Oncologia medica ed Ematologia (Site 0352) Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Texas Oncology-Austin Midtown (Site 8002) Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Dana Farber Cancer Institute (Site 0002) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| City of Hope (Site 0001) Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Banner MD Anderson Cancer Center (Site 0020) Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Ronald Reagan UCLA Medical Center (Radiological Sciences) (Site 0007) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Pacific Cancer Care (Site 0006) Coordinator of this site? Confirm its status | Monterey | United States | Unknown status |
| Fox Chase Cancer Center (Site 0019) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California San Francisco (Site 0023) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.