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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)
NCT03598608 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- BIOLOGICAL Favezelimab
Study Locations (20)
California
- City of Hope ( Site 0001) — Duarte
- Ronald Reagan UCLA Medical Center (Radiological Sciences) ( Site 0007) — Los Angeles
- Pacific Cancer Care ( Site 0006) — Monterey
- University of California San Francisco ( Site 0023) — San Francisco
Victoria
- Monash Health ( Site 0201) — Clayton
- St Vincent s Hospital (Melbourne) Limited ( Site 0202) — Fitzroy
Other
- Rambam Medical Center ( Site 0382) — Haifa
- Hadassah Ein Karem Jerusalem ( Site 0383) — Jerusalem
Arizona
- Banner MD Anderson Cancer Center ( Site 0020) — Gilbert
Massachusetts
- Dana Farber Cancer Institute ( Site 0002) — Boston
Pennsylvania
- Fox Chase Cancer Center ( Site 0019) — Philadelphia
Texas
- Texas Oncology-Austin Midtown ( Site 8002) — Austin
New South Wales
- Concord Repatriation & General Hospital ( Site 0203) — Concord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2026-01-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03598608
The ClinicalTrials.gov registry entry for NCT03598608 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 2 interventions — of which pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03598608 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Victoria, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03598608 about?
NCT03598608 is a clinical study titled "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)". 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) * indol...
What is the current status of trial NCT03598608?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2018-10-17. Estimated completion is 2026-01-28.
What conditions does trial NCT03598608 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Hodgkin Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03598608?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), Favezelimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03598608?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03598608 being conducted?
This trial has 20 study locations across Arizona, California, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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