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A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA) Combination Immunotherapy in Subjects with Recurrent And/or Metastatic HNSCC and High-Risk HPV16 Infection

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Trial Profile

A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA) Combination Immunotherapy in Subjects with Recurrent And/or Metastatic HNSCC and High-Risk HPV16 Infection

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Dec 2025

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At a glance

  • Drugs PDS 0101 (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms VERSATILE-002
  • Sponsors PDS Biotechnology Corporation

Most Recent Events

  • 02 Dec 2025 According to a PDS Biotechnology Corporation Media Release,the Company will provide further updates once it receive the FDAs meeting minutes in January 2026.
  • 29 Oct 2025 According to a PDS Biotechnology Corporation Media Release,the Company has requested a meeting with the Food and Drug Administration (FDA) to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE 002 trial and a proposed amendment to Ongoing VERSATILE-003 Trial to include PFS Endpoint.
  • 01 Oct 2025 Status changed from active, no longer recruiting to completed.

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