Anti-PD1 refractory/relapsed, unresectable Stage III or IV melanoma.

Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma.

This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-PD1-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients in single agent calibrator arms, who experience disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.

Inclusions/Exclusions: unresectable Stage III or IV (metastatic) cutaneous melanoma. Measurable disease by RECIST. ECOG 0-1. PD after anti-PD-1 regimen. LDH WNL. No uveal, acral, or mucosal melanoma.

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