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A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma

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Trial Profile

A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2025

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At a glance

  • Drugs PDS 0101 (Primary) ; PDS 0301 (Primary) ; Pembrolizumab (Primary)
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms VERSATILE-003
  • Sponsors PDS Biotechnology Corporation

Most Recent Events

  • 09 Jun 2025 According to a PDS Biotechnology Corporation Media Release, Dr Price is the global principal investigator for the VERSATILE-003 study
  • 22 May 2025 Trial design presented in the Media Release
  • 21 May 2025 Planned initiation date changed from 1 Apr 2025 to 1 May 2025.

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