Immunotherapy plus precision radiation shows promise for Tough-to-Treat head and neck cancers

NCT ID NCT03546582

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

Summary

This phase II trial tests whether adding the immunotherapy drug pembrolizumab (Keytruda) to high-precision radiation (SBRT) can help people with head and neck cancer that has come back or is a new tumor in the same area. About 86 participants will receive either the combination or radiation alone. The goal is to see if the combo delays cancer growth better than radiation by itself.

What this could mean

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

Active substance
Pembrolizumab (Keytruda) and stereotactic body radiation therapy (SBRT)
What this could lead to
If successful, this combination could offer a new treatment option to delay cancer progression in patients with recurrent head and neck cancer who have limited choices.
What could go wrong
This is a phase II trial with only 86 participants, so results are preliminary. Adding immunotherapy to radiation may increase side effects, and the benefit over radiation alone is not yet proven.

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Conditions

The condition(s) this trial relates to.

head and neck 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.

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Centre Hospitalier de l'université de Montréal

    Montreal, Quebec, H2X 3E4, Canada

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic - Weston

    Weston, Florida, 33331, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • McGill University

    Montreal, Quebec, H4A 3J1, Canada

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719, United States

  • University of Cincinnati Cancer Center - UC Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Louisville, James Graham Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • University of Pittsburgh Medical Center Shadyside

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • Washington University St. Louis

    St Louis, Missouri, 63110, United States

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