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

Trial status:Recruitment Complete
Study Identifier:
BNT111-01
ClinicalTrials.gov Identifier:
NCT04526899
EudraCT Identifier:
2020-002195-12
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruitment Complete

Trial details

Medical Condition
  • Skin Cancer
    • Study Drug
  • Biological: BNT111
  • Biological: Cemiplimab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+
    Estimated Trial Date
    May 2021 - Jan 2024

    Protocol 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.

    Trial locations

    Location
    Status
    Location
    University Of Arizona College Of Medicine
    Tucson, Arizona, United States, 85724
    Status
    Location
    University of California, San Francisco: Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, United States, 94158-3214
    Status
    Location
    Sylvester Comprehensive Cancer Center/ UMHC
    Miami, Florida, United States, 33136
    Status
    Location
    Oncology Hematology West P.C. dba Nebraska Cancer Specialists
    Omaha, Nebraska, United States, 68310
    Status
    Location
    Atlantic Health System / Morristown Medical Center
    Morristown, New Jersey, United States, 07962
    Status
    Location
    Inova Dwight and Martha Schar Cancer Institute
    Fairfax, Virginia, United States, 22031
    Status