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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

NCT04526899 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-01-08

Study results available
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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.

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV
  • Unresectable Melanoma

Interventions

BIOLOGICAL

BNT111

IV injection

BIOLOGICAL

Cemiplimab

IV infusion

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-01-25
Completion
2025-11-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04526899 on ClinicalTrials.gov