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: 13 Oct 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

01 Oct 2025 Status changed from active, no longer recruiting to completed.
25 Aug 2025 Results published in the Media Release
02 Jun 2025 According to a PDS Biotechnology Corporation Media Release, the data from this study were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

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