Trial Profile

A Phase 2 and Phase 3 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 31 Mar 2025

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At a glance

Drugs Cemiplimab (Primary) ; Fianlimab (Primary) ; Pembrolizumab
Indications Malignant melanoma; Skin cancer
Focus Registrational; Therapeutic Use
Sponsors Regeneron Pharmaceuticals

Most Recent Events

18 Oct 2024 Status changed from not yet recruiting to recruiting.
13 May 2024 Protocol of this study has been amended as phase has been amended to phase 2/3, Number of treatment arms changed to 3 from 2, Planned number of patients changed from 360 to 520.
13 May 2024 Planned End Date changed from 23 Dec 2030 to 4 Jun 2033.

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