A Phase 1/2 interventional study of pembrolizumab and Favezelimab in Hodgkin Disease, Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, sponsored by Merck Sharp & Dohme LLC. Terminated at 25 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Merck Sharp & Dohme LLC · Phase 1/2, Interventional, and Treatment
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:
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.
Per protocol amendment 7, the secondary serum concentration endpoints were removed and will not be reported.
885 studies on the registry are indexed under Hodgkin Disease; 132 are open to participants now.
This study's enrollment of 137 is above the median of 44 across 726 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive 200 mg pembrolizumab by intravenous (IV) infusion followed by favezelimab Dose A by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Biological: pembrolizumab · Biological: Favezelimab
Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose B by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Biological: pembrolizumab · Biological: Favezelimab
Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose C by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Biological: pembrolizumab · Biological: Favezelimab
Participants with cHL receive 200 mg pembrolizumab by IV infusion followed by the recommended Phase 2 dose (RP2D) of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Biological: pembrolizumab · Biological: Favezelimab
Participants with DLBCL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Biological: pembrolizumab · Biological: Favezelimab
Participants with iNHL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Biological: pembrolizumab · Biological: Favezelimab
Participants with cHL receive either pembrolizumab by IV infusion or the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to approximately 2 years).
Biological: pembrolizumab · Biological: Favezelimab
Administered as an IV infusion every 3 weeks (Q3W)
Also known as: KEYTRUDA®, MK-3475
Administered as an IV infusion Q3W
Also known as: MK-4280
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle and reported as the percentage of participants experiencing a DLT defined by the National Cancer Institute Common Terminology for Adverse Events version 4.0.
Time frame: Cycle 1 (up to 21 days)
Percentage of Participants Experiencing an Adverse Event (AE)
Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment
Time frame: 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
Percentage of participants discontinuing study treatment due to an AE
Time frame: From time of signing informed consent form (ICF) until the end of study treatment (up to approximately 24 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who had a Complete Response or a Partial Response per lymphoma disease response criteria (Cheson et. al., 2007) as assessed by the investigator.
Time frame: Up to approximately 24 months
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC