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An Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

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Trial Profile

An Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Nov 2024

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At a glance

  • Drugs BNT 111 (Primary) ; Cemiplimab (Primary)
  • Indications Malignant melanoma
  • Focus Therapeutic Use
  • Sponsors BioNTech

    • Most Recent Events

    • 04 Nov 2024 According to BioNTech media release, company plans to present data from this trial at an upcoming medical conference in 2025. The Phase 2 trial will continue as planned to further assess the secondary endpoints which were not mature at the time of the primary analysis.
    • 05 Aug 2024 According to BioNTech media release, Phase 2 trial will continue as planned to further assess the secondary endpoints which were not mature at the time of the primary analysis and plans to present data from this trial at an upcoming medical conference.
    • 30 Jul 2024 According to BioNTech media release, Primary endpoint (Objective response rate (ORR) - Arm: BNT111 + cemiplimab) has been met.

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