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
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.
Timeline
- Start
- 2021-05-19
- Primary completion
- 2024-01-25
- Completion
- 2025-11-24
Outcome
Met primary endpoint
registry NUMBER Arm 1: BNT111 + Cemiplimab: 18.0 (10.64 to 27.55) percentage of participants NCT04526899 ↗
registry analysis (superiority test); Arm 1: BNT111 + Cemiplimab; p = 0.0148; 1-sided exact binomial test NCT04526899 ↗
release “Primary endpoint met in a Phase 2 trial evaluating the investigational mRNA immunotherapy BNT111 in combination with the PD-1 checkpoint inhibitor cemiplimab” biontech.com ↗
release “the trial met its primary endpoint demonstrating statistically significant improvement in objective response rate (“ORR”) in patients treated with BNT111 in combination with cemiplimab” biontech.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT111 | Vaccine | — | Intravenous |
| Subject | Cemiplimab | Monoclonal antibody | — | Intravenous |