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Can adding radiation boost immunotherapy against spread head and neck cancer?

NCT ID NCT04747054

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether adding radiotherapy to the immunotherapy drug pembrolizumab (with or without chemotherapy) helps people with newly diagnosed head and neck cancer that has spread to other parts of the body. Participants receive either standard systemic treatment alone or the same treatment plus radiation to the tumor area. The study measures how long patients live without the cancer getting worse and overall survival.

What this could mean

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

Active substance
Pembrolizumab (an immunotherapy drug) plus loco-regional radiotherapy
What this could lead to
If adding radiotherapy to pembrolizumab works, it could slow cancer growth and extend survival for people with metastatic head and neck cancer.
What could go wrong
This is a phase 3 trial, but results are not guaranteed. Radiotherapy may add side effects, and the benefit over standard treatment is uncertain.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient must have signed a written informed consent form prior to any study specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent. 2. Histologically confirmed squamous cell carcinoma of head and neck (oral cavity, oropharynx, hypopharynx, and larynx) including unknown primary head and neck lymph nodes with distant metastases at presentation (T1-4 N0-3 M1). Histological confirmation is required in case of a single metastatic lesion. 3. Eligible for treatment by pembrolizumab according to the European Marketing Authorization 4. Patient ≥18 years old 5. Performance status: 0-1 (WHO) 6. Combined Positive Score (CPS) ≥1 for primary tumor (as determined per local practice) 7. Subjects must have at least one measurable lesion as per RECIST v1.1 to assess efficacy 8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization: a. If randomization is done before treatment start: i. Absolute neutrophil count ≥1.5 × 10⁹/L ii. Platelet ≥100 × 10⁹/L iii. Hemoglobin ≥90 g/L iv. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT), ≤3 × upper limit of normal (ULN), (unless documented liver metastases where ≤5 x ULN is permitted) v. Bilirubin ≤1.5 × ULN. vi. Serum albumin ≥25 g/L vii. Creatinine clearance ≥30 mL/min (calculated per institutional guidelines or by Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula) viii. Corrected serum calcium of ≤11.5 mg/dL or ≤2.6 mmol/L. b. If randomization if done after treatment start i. Absolute neutrophil count ≥1.0 × 10⁹/L ii. Platelet ≥75 × 10⁹/L iii. Hemoglobin ≥85 g/L 9. Patient must agree to use adequate contraception methods for the duration of the study treatment and up to 4 months after the last dose of pembrolizumab administration 10. Patients must be affiliated to a Social Security System (or equivalent) 11. No disease progression during systemic treatment if the randomization is done after the start of pembrolizumab for the current disease Exclusion Criteria: 1. Symptomatic central nervous system (CNS) metastases and / or carcinomatous meningitis 2. History of another malignancy within 2 years prior to study inclusion, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma 3. Prior radiotherapy in the head and neck region 4. Any prior or current non-surgical treatment for invasive head and neck cancer. (except for pembrolizumab +/- chemotherapy for the current cancer for a maximum of 6 cycles). This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, chemotherapy, anti-PD-1/PD-L1 and CTLA-4, prior radiotherapy (RT), or use of any investigational agent. Loco-regional recurrent or second primary head and neck cancer after prior surgical treatment alone in the head and neck region could be eligible. 5. Known Acquired Immune Deficiency Syndrome (AIDS) 6. Known currently active infection including hepatitis B or hepatitis C 7. Patient having received live attenuated vaccine within 28 days prior to enrolment 8. Pregnant or breast feeding woman 9. Active autoimmune disease except vitiligo, type-1 diabetes, hypothyroid stabilized with hormonal substitution, or psoriasis which do not require systemic treatment 10. Active immunodeficiency or ongoing immunosuppressive therapy 11. Active symptomatic interstitial lung disease 12. Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial 13. Any social, personal, medical, geographic and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent 14. Prior organ transplantation including allogenic stem-cell transplantation 15. Other severe acute or chronic medical conditions including colitis, pneumonitis, pulmonary fibrosis or psychiatric conditions including active suicidal ideation; or laboratory abnormalities that may increase the risk associated with study participation and, in the judgment of the investigator, would make the patient inappropriate for entry into this study 16. Person deprived of their liberty or under protective custody or guardianship 17. Patient who have taken any investigational medicinal product or have used an investigational device within 30 days prior to study inclusion

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Conditions

The condition(s) this trial relates to.

carcinoma head and neck squamous cell carcinoma Neoplasm Metastasis 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.

Squamous cell carcinoma of head and neck

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Carcassonne

    RECRUITING

    Carcassonne, 1A810, France

  • CH Valence

    NOT_YET_RECRUITING

    Valence, 26953, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, 33075, France

  • CHU Jean Minjoz

    RECRUITING

    Besançon, 25030, France

  • CHU de Saint Etienne

    NOT_YET_RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, France

  • Centre François Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, France

  • Centre Guillaume le Conquérant

    SUSPENDED

    Le Havre, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 76038, France

  • Centre Jean Bernard - Clinique Victor Hugo

    RECRUITING

    Le Mans, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    WITHDRAWN

    Lyon, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

  • Groupe Hospitalier Bretagne Sud

    RECRUITING

    Lorient, France

  • Gustave Roussy

    RECRUITING

    Villejuif, France

  • Hopital Nord Franche Comté - Site de Mittan

    RECRUITING

    Montbéliard, 25209, France

  • Hopital Privé Drome Ardeche

    NOT_YET_RECRUITING

    Valence, 26000, France

  • Hopital de la Timone

    RECRUITING

    Marseille, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, France

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Institut Jean Godinot

    RECRUITING

    Reims, 51726, France

  • Institut Sainte Catherine

    RECRUITING

    Avignon, 84000, France

  • Institut de Cancérologie Strasbourg-Europe

    RECRUITING

    Strasbourg, France

  • Institut de Cancérologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Polyclinique de l'Ormeau

    NOT_YET_RECRUITING

    Tarbes, 65000, France

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