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An Open Label Phase II Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1 (AHEAD-MERIT)

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Trial Profile

An Open Label Phase II Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1 (AHEAD-MERIT)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 30 Jan 2025

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At a glance

  • Drugs BNT 113 (Primary) ; Pembrolizumab (Primary)
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms AHEAD-MERIT
  • Sponsors BioNTech

    • Most Recent Events

    • 04 Nov 2024 According to a BioNTech media release, In September 2024, an exploratory analysis of antitumor activity (15 patients) and immunogenicity (3 patients) from the safety run-in of AHEAD-MERIT was presented at ESMO. The data support the tolerability of BNT113 and clinical activity in combination with pembrolizumab was observed. In addition, BNT113 was found to induce de novo T-cell responses against HPV16 antigens.
    • 05 Aug 2024 According to a BioNTech media release, data updates are expected to be presented at the 2024 Congress of the European Society of Medical Oncology) taking place from September 13-17, 2024 in Barcelona, Spain.
    • 27 Mar 2023 According to a BioNTech media release, As of July 5, 2022, of 15 treated patients, 12 had completed the safety run-in (pembrolizumab + four BNT113 doses). The randomized Part B is ongoing.

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