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
2상
완료
NCT04526899
| 대상 질환 | Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma |
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| 임상 단계 | 2상 |
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| 스폰서 | BioNTech SE |
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| 상태 | 완료 |
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| 참여자 수 | 184 명 |
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| 중재(약물) | BNT111, Cemiplimab |
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| 시작일 | 2021년 5월 19일 |
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| 완료일 | 2024년 1월 25일 |
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| 결과 공개일 | 2025년 12월 15일 |
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요약
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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