NCT04526899

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

Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma Stage III
• Melanoma Stage IV
• Unresectable Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	BNT111	IV injection
BIOLOGICAL	Cemiplimab	IV infusion

Timeline

• Start date: 2021-05-19
• Primary completion: 2024-01-25
• Completion: 2025-11-24
• First posted: 2020-08-26
• Last updated: 2026-01-08
• Results posted: 2025-12-15

Locations

49 sites across 7 countries: United States, Australia, Germany, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study