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An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

Trial Profile

An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

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

Latest Information Update: 24 Feb 2025

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At a glance

  • Drugs Belzutifan (Primary) ; Everolimus
  • Indications Renal cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms LITESPARK-005
  • Sponsors Merck Sharp & Dohme Corp.
  • Most Recent Events

    • 17 Feb 2025 Planned End Date changed from 17 Sep 2025 to 17 Sep 2026.
    • 27 Jan 2025 According to a Merck Sharp & Dohme media release, based on result from this trial the company received WELIREG approval in Canada for the treatment of adult patients with advanced RCC following a PD-1/PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
    • 13 Dec 2024 According to a Merck & Co Media Release, based on results from this trial the EMA's CHMP has adopted a positive opinion recommending the conditional approval of WELIREG, for the treatment of adult patients with advanced RCC that progressed following two or more lines of therapy that included a programmed death receptor-1 or PDL-1 inhibitor and at least two vascular endothelial growth factor targeted therapies. The final EU decision is expected in first half of 2025.

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