New combo aims to boost immune attack on HPV-Driven head and neck cancer

NCT ID NCT06790966

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding an experimental immunotherapy called PDS0101 to the standard drug pembrolizumab helps people with advanced HPV16-positive head and neck cancer live longer. About 252 participants will receive either the combination or pembrolizumab alone. The study is active but no longer recruiting.

What this could mean

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

Active substance: PDS0101 (a vaccine-like immunotherapy) and pembrolizumab (an immunotherapy drug)
What this could lead to: If it works, this combination could become a new first-line treatment that helps people with HPV16-positive head and neck cancer live longer and keep their cancer under control.
What could go wrong: This is a Phase 3 trial, but it's still experimental. The combination may not work better than pembrolizumab alone, and could cause additional side effects like immune reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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 squamous cell neoplasm

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 UNRESECTABLE HEAD AND NECK SQUAMOUS CELL CARCINOMA

Contacts and locations

Locations

Emory University - Winship Cancer Institute (WCI)

Atlanta, Georgia, 30322, United States
Florida Cancer Affiliates - Ocala Oncology

Ocala, Florida, 34474, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19103, United States
Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Marin Cancer Care

Greenbrae, California, 94904, United States
Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States
Mayo Clinic Florida

Jacksonville, Florida, 32224, United States
Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States
Medical University of South Carolina

Charleston, South Carolina, 29407, United States
Norton Cancer Institute

Louisville, Kentucky, 40202, United States
Penn State Health

Hershey, Pennsylvania, 17033, United States
SCRI - Florida Cancer Specialists

Orlando, Florida, 32827, United States
Texas Oncology

Austin, Texas, 78705, United States
Texas Oncology-Northeast Texas

Tyler, Texas, 75702, United States
The Ohio State University- James Cancer Hospital

Columbus, Ohio, 43210, United States
UT Health San Antonio

San Antonio, Texas, 78229, United States
University of California, Orange

Orange, California, 92686, United States
University of Kansas

Westwood, Kansas, 66205, United States
University of Kentucky

Lexington, Kentucky, 40536, United States
University of Louisville

Louisville, Kentucky, 40202, United States
University of Maryland

Baltimore, Maryland, 21201, United States
University of Michigan

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

Chapel Hill, North Carolina, 27599-7025, United States
University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States
University of Virginia Health System

Charlottesville, Virginia, 22903, United States
Virginia Oncology Associates

Norfolk, Virginia, 23502, United States
West Virginia University Cancer Center

Morgantown, West Virginia, 26506, United States
Yale University

New Haven, Connecticut, 06510, United States

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