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
Phase 2
Completed
NCT04526899
| Condition | Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma |
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| Phase | Phase 2 |
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| Sponsor | BioNTech SE |
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| Status | Completed |
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| Enrollment | 184 participants |
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| Interventions | BNT111, Cemiplimab |
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| Start date | May 19, 2021 |
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| Completion date | Jan 25, 2024 |
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| Results posted | Dec 15, 2025 |
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Summary
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-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.
Arm 1: Objective Response Rate (ORR)
Up to 24 months · percentage of participants
| Arm 1: BNT111 + Cemiplimab | 18.0 percentage of participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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