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BNT111

A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment

Ensayo de BioNTech SE en Melanoma Stage III · Melanoma Stage IV · Unresectable Melanoma (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

184

previstos

Centros

49

Fin del objetivo primario

ene 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en may 2021.

Qué mide

Arm 1: Objective Response Rate (ORR) (del registro, en inglés) (hasta 24 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-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 will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.

Más ensayos de BNTX

Todos los de BNTX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04526899), actualizada en dic 2025.