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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)

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Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Sep 2026

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At a glance

  • Drugs Belzutifan (Primary) ; Pembrolizumab (Primary)
  • Indications Renal cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms LITESPARK-022; MK-6482-022
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 12 Jun 2026 Results presented in the Dana-Farber cancer institute media release.
  • 12 Jun 2026 According to a Dana-Farber cancer institute media release, data from this study presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium, and published in the New England Journal of Medicine.
  • 12 Jun 2026 According to Merck media release, company announced that the U.S. Food and Drug Administration (FDA) approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with WELIREG (belzutifan) for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy.

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