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An Open-label Phase II/III 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

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An Open-label Phase II/III 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

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Apr 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

  • 17 Mar 2025 The protocol has been amended to change in study phase.
  • 17 Mar 2025 Planned number of patients changed from 285 to 350.
  • 17 Mar 2025 Planned End Date changed from 1 May 2028 to 1 Apr 2029.

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