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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: 19 Aug 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

    • 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.
    • 30 Jul 2024 Results evaluating the investigational mRNA cancer immunotherapy BNT111 in combination with cemiplimab published in the BioNTech Media Release

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