Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)
NCT02684292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304
Last updated 2026-02-18
Summary
The purpose of this study is to evaluate pembrolizumab (MK-3475) in the treatment of participants with relapsed or refractory Classical Hodgkin Lymphoma. Participants will be randomized to receive either pembrolizumab or brentuximab vedotin (BV) for up to 35 three-week cycles of treatment.
The primary hypotheses of this study are that treatment with pembrolizumab prolongs Progression-free Survival (PFS) and Overall Survival (OS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with BV.
Conditions
Interventions
- BIOLOGICAL
-
IV infusion
- BIOLOGICAL
-
brentuximab vedotin
IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-23
- Primary Completion
- 2026-01-14
- Completion
- 2026-01-14
- FDA Drug
- Yes
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