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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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Trial Profile

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: 14 Feb 2026

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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

  • 29 Jan 2026 According to a BioNTech media release, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BNT113, based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial (NCT04534205) evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1.
  • 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.

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