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New combo therapy aims to slow head and neck cancer spread

NCT ID NCT05815927

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding precise, high-dose radiation (SABR) to the standard immunotherapy drug pembrolizumab can help people with head and neck cancer that has spread to 1-5 spots in the body. About 200 adults with a specific type of head and neck cancer will be randomly assigned to receive either pembrolizumab alone or pembrolizumab plus SABR. The goal is to see if the combination delays cancer growth longer than the drug alone.

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 200 people

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

Started

May 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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.

Main inclusion Criteria: * Male/female participants who are at least 18 years of age on the day of signing informed consent * Histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or cervical primary occult and histologically or radiologically confirmed oligometastatic disease. Histological characterization of one metastatic lesion is strongly recommended. * Patients with synchronous or metachronous oligometastatic disease according to the ESTRO/EORTC consensus (1-5 metastatic lesions, with or without primary/recurrent primary tumour and/or regional disease). * Amenable to first-line systemic treatment for R/M SCCHN. * For patients with oropharyngeal cancer: HPV status using p16 IHC evaluated locally. * PD-L1 CPS of at least 1 as evaluated locally. * Staging not older than 12 weeks before enrolment. * All the 1-5 metastases must be amenable to SABR. * Eligible for treatment with pembrolizumab. * Have measurable disease based on RECIST 1.1. * ECOG performance status of 0 to 1. * Participants must have recovered from all treatment-related toxicities to baseline or grade ≤1, such as from previous radiotherapy, systemic treatment or surgery, and not requiring corticosteroids for managing treatment-related side effects. * Adequate Organ Function Laboratory Values. * Before patient registration/enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations. Main exclusion Criteria: * Nasopharynx, sino-nasal, and salivary gland cancers are excluded. * In-field progression in \< 6 months after curative intended locoregional irradiation of the head and neck. * Lesions larger than 6 cm in the largest dimension as measured in the diagnostic CT or MRI scan for lesions outside the brain. Note: bone metastases over 6 cm may be included if in the opinion of the local radiation oncologist they can be treated safely and no inner organ is affected. * Brain metastases only. * Has received any previous radiotherapy to any of the 1-5 metastases that would be subject to SABR in the experimental arm unless the investigator agrees to treat only after discussion with the RTQA team. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. * Previously treated brain metastases that are radiologically non-stable. Patients with previously treated brain metastases, i.e., without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention, can participate. * Known contraindication to imaging tracer or any product of contrast media and MRI contraindications.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma

As listed by the trial registrant

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

Oligometastatic squamous cell carcinoma of the 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

    30 sites in 4 countries. 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

  • AUSL Romagna - AUSL Della Romagna -Ospedale Santa Maria delle Croci

    NOT_YET_RECRUITING

    Ravenna, 48121, Italy

  • AZ Groeninge Kortrijk - Campus Kennedylaan

    RECRUITING

    Kortrijk, 8500, Belgium

  • Azienda Ospedaliera Santa Croce E Carle

    NOT_YET_RECRUITING

    Cuneo, 12100, Italy

  • Azienda Sanitaria Locale Napoli 1 Centro

    NOT_YET_RECRUITING

    Naples, 80147, Italy

  • Azienda ospedaliero Univ Policlinico Umberto I

    RECRUITING

    Rome, 00161, Italy

  • CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont

    NOT_YET_RECRUITING

    Haine-Saint-Paul, 7100, Belgium

  • CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur

    RECRUITING

    Namur, 5000, Belgium

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 De Octubre

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario De Cruces

    NOT_YET_RECRUITING

    Barakaldo, 48903, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Virgen De La Victoria

    NOT_YET_RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrin

    RECRUITING

    Las Palmas de Gran Canaria, 35010, Spain

  • ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

    RECRUITING

    Barcelona, 08908, Spain

  • IRCCS - Fondazione Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • IRCCS--Ospedale Bellaria-Bologna

    NOT_YET_RECRUITING

    Bologna, 40139, Italy

  • Inselspital - Inselspital

    RECRUITING

    Bern, 3010, Switzerland

  • Institut Català d'Oncologia - Hospital Duran i Reynals

    NOT_YET_RECRUITING

    Badalona, 08916, Spain

  • Istituto Clinico Humanitas

    RECRUITING

    Milan, 20089, Italy

  • Kantonsspital Aarau

    NOT_YET_RECRUITING

    Aarau, 5001, Switzerland

  • Kantonsspital Graubuenden

    NOT_YET_RECRUITING

    Chur, 7000, Switzerland

  • Kantonsspital Winterthur

    NOT_YET_RECRUITING

    Winterthur, 8401, Switzerland

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, 6004, Switzerland

  • Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale San Giovanni

    NOT_YET_RECRUITING

    Bellinzona, 6500, Switzerland

  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • UniversitaetsSpital Zurich

    RECRUITING

    Zurich, 8901, Switzerland

  • VITAZ St Niklaas - VITAZ- Oncology

    RECRUITING

    Sint-Niklaas, 9100, Belgium

  • Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA)

    RECRUITING

    Wilrijk, 2610, Belgium