TerminatedPhase 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)

Stopped: Business Reason

United States, Australia, Canada137 participantsStarted 2018-10-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 immunod…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated early — can you tell me why it was stopped, and whether that means there were safety concerns or unexpected side effects with the favezelimab and pembrolizumab combination that I should know about?
2Since this was a Phase 1/Phase 2 study and one of the main things it was measuring was how many people had to stop treatment due to adverse events, what does that tell us about how well this drug combination was tolerated, and would that affect whether you'd recommend a similar approach for me?
3Given that this trial is no longer enrolling, are there other active clinical trials studying similar checkpoint inhibitor combinations for Hodgkin disease or B-cell lymphoma that might be worth looking into?
4How does combining favezelimab with pembrolizumab — which targets a different immune checkpoint than pembrolizumab alone — compare to standard treatments currently available for my specific diagnosis, and would you recommend trying a proven standard therapy first?
5Because this trial focused on hematologic malignancies broadly, including both Hodgkin disease and various types of non-Hodgkin lymphoma, does the fact that it was terminated affect what we know about effectiveness for my particular type of lymphoma specifically?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)

Timeframe: Cycle 1 (up to 21 days)

Percentage of Participants Experiencing an Adverse Event (AE)

Timeframe: From time of signing informed consent form (ICF) until the end of follow-up (up to approximately 27 months)

Percentage of Participants with Treatment Discontinuations Due to an AE

Timeframe: From time of signing informed consent form (ICF) until the end of study treatment (up to approximately 24 months)

Trial details

NCT IDNCT03598608

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-28

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