Trial Profile

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 10 Aug 2025

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At a glance

Drugs Cemiplimab (Primary) ; Fianlimab (Primary) ; Nivolumab/relatlimab
Indications Malignant melanoma
Focus Therapeutic Use
Sponsors Regeneron Pharmaceuticals

Most Recent Events

14 May 2025 Planned End Date changed from 26 Jun 2033 to 10 Jul 2033.
13 Jan 2025 According to a Regeneron Pharmaceuticals media release, Results from the first Phase 3 study in first-line metastatic melanoma are expected in the second half of 2025, with a potential BLA submission to follow.
09 Aug 2024 Status changed from not yet recruiting to recruiting.

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