OncRef

Clinical Trial: NCT02684292

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-02-18

Study Overview

Brief 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.

Official Title

A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

Conditions

Hodgkin Lymphoma

Intervention / Treatment

  • Biological: pembrolizumab
  • Biological: brentuximab vedotin

Other Study ID Numbers

  • 3475-204
  • 163337
  • MK-3475-204
  • KEYNOTE-204
  • 2022-500400-22-00
  • U1111-1275-8432
  • 2015-005053-12
  • 2015

Start Date (Actual)

2016-05-23

Primary Completion Date (Actual)

2026-01-14

Study Completion Date (Actual)

2026-01-14

Enrollment (Actual)

304

Study Type

Interventional

Phase

Phase 3