Trial Profile

An Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 12 Jan 2026

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At a glance

Drugs BNT 111 (Primary) ; Cemiplimab (Primary)
Indications Malignant melanoma
Focus Therapeutic Use
Sponsors BioNTech

Most Recent Events

08 Jan 2026 Status changed from active, no longer recruiting to completed.
29 May 2025 Planned End Date changed from 1 Jul 2026 to 1 Dec 2025.
04 Nov 2024 According to BioNTech media release, company plans to present data from this trial at an upcoming medical conference in 2025. The Phase 2 trial will continue as planned to further assess the secondary endpoints which were not mature at the time of the primary analysis.

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