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Study identifier: NCT04260126 Synced from ClinicalTrials.gov · July 28, 2026
● Completed

Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

Condition: Metastatic Head and Neck Cancer · Recurrent Head and Neck Cancer · HPV Positive Oropharyngeal Squamous Cell Carcinoma  ·  Sponsor: PDS Biotechnology Corp.

PhasePhase 2
Planned participants95
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (23)

Marin Cancer CenterGreenbrae, California, United States
University of California San FranciscoSan Francisco, California, United States
Mayo ClinicJacksonville, Florida, United States
Cleveland Clinic FloridaWeston, Florida, United States
University of Kentucky Chandler Medical Center - Markey Cancer CenterLexington, Kentucky, United States
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, Maryland, United States
University of MichiganAnn Arbor, Michigan, United States
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan, United States
Mayo ClinicRochester, Minnesota, United States
Atlantic HealthMorristown, New Jersey, United States
University of North CarolinaChapel Hill, North Carolina, United States
Ohio State UniversityColumbus, Ohio, United States

+ 11 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04260126