Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT02684292
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pembrolizumab — BIOLOGICAL
    IV infusion
  • brentuximab vedotin — BIOLOGICAL
    IV infusion

Study Details

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.

Key Dates

Start date
May 23, 2016
Status verified
Feb 2026
Primary completion
Jan 14, 2026
Completion
Jan 14, 2026

Study Design

Enrollment
304 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Participants receive pembrolizumab 200 mg administered intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles.
  • Active Comparator: Brentuximab vedotin
    Participants receive BV 1.8 mg/kg (maximum 180 mg per dose) IV on Day 1 of each 3-week cycle for up to 35 cycles.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 40 months ]

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