Experimental combo targets HPV-Driven head and neck tumors

NCT ID NCT04260126

Completed Disease control Sponsor: PDS Biotechnology Corp. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested a combination of two immunotherapies—PDS0101 and pembrolizumab (Keytruda)—in 95 adults with HPV16-positive head and neck cancer that had returned or spread. The goal was to see if the combo could shrink tumors or slow the disease. Participants received both drugs through IV and injections over several cycles. The study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: PDS0101 (an investigational immunotherapy) combined with pembrolizumab (Keytruda)
What this could lead to: If successful, this combination could offer a new treatment option for people with HPV16-related head and neck cancer that has returned or spread.
What could go wrong: This is a Phase 2 trial with only 95 participants, so results are preliminary. The combination may not work better than existing treatments and could cause side effects like immune-related reactions.

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Conditions

The condition(s) this trial relates to.

head and neck cancer head and neck neoplasm Head and Neck Neoplasms head and neck squamous cell carcinoma oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HPV-POSITIVE OROPHARYNGEAL SQUAMOUS CELL CARCINOMA METASTATIC HEAD AND NECK CANCER NEOPLASMS, HEAD AND NECK RECURRENT HEAD AND NECK CANCER

Contacts and locations

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Locations

Atlantic Health

Morristown, New Jersey, 07962, United States
Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Cleveland Clinic Florida

Weston, Florida, 33331, United States
Edinburgh Cancer Centre

Edinburgh, UK EH4 2XU, United Kingdom
FDI Clinical Research

San Juan, Puerto Rico, 00927, Puerto Rico
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Marin Cancer Center

Greenbrae, California, 94904, United States
Mayo Clinic

Jacksonville, Florida, 32224, United States
Mayo Clinic

Rochester, Minnesota, 55902, United States
Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, 29425, United States
Ohio State University

Columbus, Ohio, 43210, United States
St. James Hospital

Dublin, D08NHY1, Ireland
Texas Oncology - Sammons Cancer Center

Dallas, Texas, 75246, United States
The Royal Marsden NHS Foundation Trust (Chelsea)

Chelsea, London, SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust (Sutton)

Sutton, Surrey, SM2 5PT, United Kingdom
The University of Virginia

Charlottesville, Virginia, 22908, United States
University of California San Francisco

San Francisco, California, 94158, United States
University of Kentucky Chandler Medical Center - Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of North Carolina

Chapel Hill, North Carolina, 27599, United States
University of Tennessee

Knoxville, Tennessee, 37920, United States
West Virginia University

Morgantown, West Virginia, 26506, United States

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