Could setanaxib boost keytruda against head and neck cancer?

NCT ID NCT05323656

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 2 trial tested whether adding setanaxib (an experimental oral drug) to the standard immunotherapy pembrolizumab (Keytruda) works better than pembrolizumab alone for people with recurrent or metastatic squamous cell carcinoma of the head and neck. 55 adults whose cancer had returned or spread and who could not have surgery took part. The main goal was to see if the combination shrinks tumors more effectively.

What this could mean

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

Active substance

setanaxib (oral tablet) and pembrolizumab (Keytruda, IV infusion)

What this could lead to

If it works, this combination could slow tumor growth or shrink tumors in people with head and neck cancer that has returned or spread.

What could go wrong

This is a small, early Phase 2 trial with only 55 people. The drug may not improve outcomes over standard pembrolizumab alone, and side effects are possible.

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 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

  • Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario

    Milan, Milan, 20142, Italy

  • Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

    Amiens, Picardie, 80054, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centre de Lutte contre le Cancer - Centre Oscar Lambret

    Lille, Hauts-de-France, 59000, France

  • Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-792, Poland

  • Complejo Hospitalario de Navarra

    Pamplona, 31008, Spain

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hôpital Saint-André

    Bordeaux, 33000, France

  • Hôpital de la Timone

    Marseille, 13005, France

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, Grand Est, 54519, France

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie-Państwowy Instytut Badawczy O. w Gliwicach

    Gliwice, Silesian Voivodeship, 44-102, Poland

  • Ramsay Health Clinic Belharra

    Bayonne, 64100, France

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031, United States

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • The Royal Marsden Hospital - London

    London, England, SW3 6JJ, United Kingdom

  • The Royal Marsden Hospital Head and Neck Unit

    Sutton, England, SM5 5PT, United Kingdom

  • Washington University School of Medicine Center for Advanced Medicine

    St Louis, Missouri, 63110, United States