Can a Three-Pronged attack shrink Hard-to-Treat head and neck cancers?

NCT ID NCT04576091

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase I trial is testing whether a combination of three treatments — an experimental drug called elimusertib, precise radiation therapy, and the immunotherapy pembrolizumab — can shrink or stabilize recurrent head and neck cancer that cannot be removed by surgery. The study enrolls adults with various types of head and neck squamous cell carcinoma that have returned after prior treatment. The main goals are to find the safest dose and to watch for side effects.

What this could mean

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

Active substance
a combination of elimusertib (BAY 1895344), stereotactic body radiation therapy, and pembrolizumab
What this could lead to
If this works, it could offer a new treatment option for people with recurrent head and neck cancer that cannot be surgically removed.
What could go wrong
This is a very early phase I trial with only 7 participants, so the benefits are uncertain. The combination may cause significant side effects, and it is not yet known if it works better than existing treatments.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

CLINICAL STAGE III HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 CLINICAL STAGE IV HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 RECURRENT CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK RECURRENT HEAD AND NECK SQUAMOUS CELL CARCINOMA RECURRENT HYPOPHARYNGEAL SQUAMOUS CELL CARCINOMA RECURRENT LARYNGEAL SQUAMOUS CELL CARCINOMA RECURRENT ORAL CAVITY SQUAMOUS CELL CARCINOMA RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA RECURRENT PARANASAL SINUS SQUAMOUS CELL CARCINOMA RECURRENT SALIVARY GLAND CARCINOMA STAGE III CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AJCC V8 STAGE III HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE III LARYNGEAL CANCER AJCC V8 STAGE III LIP AND ORAL CAVITY CANCER AJCC V8 STAGE III MAJOR SALIVARY GLAND CANCER AJCC V8 STAGE III OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STAGE III SINONASAL CANCER AJCC V8 STAGE IV CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AJCC V8 STAGE IV HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IV LARYNGEAL CANCER AJCC V8 STAGE IV LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IV MAJOR SALIVARY GLAND CANCER AJCC V8 STAGE IV OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STAGE IV SINONASAL CANCER AJCC V8 UNRESECTABLE CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK UNRESECTABLE HEAD AND NECK SQUAMOUS CELL CARCINOMA UNRESECTABLE HYPOPHARYNGEAL SQUAMOUS CELL CARCINOMA UNRESECTABLE LARYNGEAL SQUAMOUS CELL CARCINOMA UNRESECTABLE ORAL CAVITY SQUAMOUS CELL CARCINOMA UNRESECTABLE OROPHARYNGEAL SQUAMOUS CELL CARCINOMA UNRESECTABLE PARANASAL SINUS SQUAMOUS CELL CARCINOMA UNRESECTABLE SALIVARY GLAND SQUAMOUS CELL CARCINOMA

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

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