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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma

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Trial Profile

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Petosemtamab (Primary)
  • Indications Carcinoma; Colorectal cancer; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Oropharyngeal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms LiGeR-HN1
  • Sponsors Merus

Most Recent Events

  • 22 May 2025 According to a Merus media release, company is looking forward to potentially sharing top line interim readout of one or both of our phase 3 trials in 2026.
  • 23 Apr 2025 According to a Merus media release, an updated analysis of the interim clinical data from the phase 2 trial of petosemtamab with pembrolizumab as 1L treatment of PD-L1+ recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) will be presented in a poster at 2025 ASCO
  • 27 Feb 2025 According to a Merus media release, the company expects this trial to be substantially enrolled by YE25.

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