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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Mar 2026

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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

  • 20 Feb 2026 According to a PDS Biotechnology Corporation media release, company announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer.
  • 12 Jan 2026 According to a PDS Biotechnology Corporation Media Release, The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer
  • 12 Jan 2026 According to a PDS Biotechnology Corporation Media Release, Company has submitted a protocol amendment to the U.S. Food & Drug Administration. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA.

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