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

NCT ID NCT06790966

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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