OncRef

Clinical Trial: NCT05239728

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-05-15

Study Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.

The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

Official Title

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

Conditions

Carcinoma, Renal Cell

Intervention / Treatment

  • Drug: Belzutifan
  • Biological: Pembrolizumab
  • Drug: Placebo

Other Study ID Numbers

  • 6482-022
  • MK-6482-022
  • LITESPARK-022
  • jRCT2051220030
  • 2023-505023-31-00
  • U1111-1290-7346
  • 2021-003436-92
  • 2023

Start Date (Actual)

2022-03-15

Primary Completion Date (Estimated)

2026-10-28

Study Completion Date (Estimated)

2029-09-28

Enrollment (Estimated)

1800

Study Type

Interventional

Phase

Phase 3