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A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

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Trial Profile

A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

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

Latest Information Update: 18 May 2026

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At a glance

  • Drugs Nivolumab (Primary) ; Nivolumab/relatlimab (Primary)
  • Indications Acral lentiginous melanoma; Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms RELATIVITY-047
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 24 Apr 2026 According to a European Medicines Agency media release, the EMA's human medicines committee (CHMP) did not recommend extending Opdualag's use to advanced melanoma with PD-L1 levels of 1% or higher, concluding the data was insufficient to prove benefits over risks. However, the European Medicines Agency (EMA) authorized updated 5-year data for patients with lower PD-L1 levels to be included in the product information.
  • 17 Mar 2025 Planned End Date changed from 16 Dec 2025 to 15 Dec 2030.
  • 04 Jun 2024 Results (At database lock 19 Oct 2023) assessing safety and efficacy of Nivolumab plus relatlimab vs NIVO in previously untreated metastatic or unresectable melanoma presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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