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A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

Trial Profile

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

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

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Pembrolizumab+vibostolimab (Primary) ; Pembrolizumab
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYVIBE-010
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 30 Apr 2025 Planned End Date changed from 31 Mar 2031 to 27 Aug 2025.
  • 06 Apr 2025 Participants will discontinue treatment with pembrolizumab/vibostolimab, as per amendment 4. The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 06-Mar-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure.
  • 13 May 2024 According to Merck and Co Media Release, company announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm.

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