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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: 09 Mar 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

  • 28 Feb 2026 According to Merck Sharp and Dohme media release, The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 19, 2026 for the WELIREG sNDA and the KEYTRUDA and KEYTRUDA QLEX sBLAs.
  • 28 Feb 2026 According to Merck Sharp and Dohme media release, the U.S. FDA has accepted for priority review supplemental applications seeking approval of WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) for the adjuvant treatment of adult patients with RCC with a clear cell component with increased risk of recurrence following nephrectomy.
  • 28 Feb 2026 Results presented in the Merck Sharp and Dohme media release.

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