RecruitingPhase 3NCT05815927

Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer

Pembrolizumab and Radiotherapy for OLigometastatic Squamous Cell Carcinoma of the Head and Neck: a Randomized Phase III Study

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

200 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

Oligometastatic Squamous Cell Carcinoma of the Head and Neck

Summary

This is a randomized open-label multicentre phase III superiority study of the effect of adding SABR to the standard of care treatment pembrolizumab on progression free survival in patients with oligometastases of a squamous cell carcinoma of the head and neck (SCCHN), histological confirmation of the primary disease at first diagnosis, and PD-L1 CPS ≥1. After eligibility check and signing informed consent, all patients will be prospectively enrolled in a 1:1 ratio between current standard of care treatment (pembrolizumab, Arm 1) vs. SABR + standard of care treatment (Arm 2) to oligometastases. Any radical treatment to the synchronous primary/ recurrent primary tumor and/or involved cervical nodes (surgery or radiotherapy), as decided by the local tumor board/ treating physicians, should be completed prior to enrolment.Surgical removal of metastases is allowed for diagnostic purposes or for brain metastases, as long as these metastases count toward the total number of 5 and at least one metastasis is left for treatment with SABR. Such surgical procedures should be performed prior to enrolment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether combining pembrolizumab (an immunotherapy drug) with targeted radiation therapy can effectively treat people with head and neck cancer that has spread to only a few spots in the body (called oligometastatic disease). The goal is to attack the cancer from two angles — radiation to the visible spots, and immunotherapy to train the immune system to fight remaining cancer cells. **You may be eligible if...** - You are 18 or older - You have head and neck cancer (oral cavity, throat, voice box, or similar) confirmed by biopsy - Your cancer has spread to 1–5 spots in the body (oligometastatic) - You have not had more than two prior lines of treatment for metastatic disease - You are in good enough health to participate (ECOG 0–1) **You may NOT be eligible if...** - You have had prior treatment with anti-PD-1/PD-L1 immunotherapy - You have active autoimmune disease requiring treatment - You have a serious infection or other uncontrolled illness - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab: 400mg Q6W up to 2 years (i.e 17 cycles).

RADIATIONstereotattic ablation radiotherapy (SABR)

Total dose and number of fractions will depend on the site of the disease. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments have to be completed within 10 working days.

Locations(26)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

AZ Groeninge Kortrijk - Campus Kennedylaan

Kortrijk, Belgium

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

Namur, Belgium

VITAZ St Niklaas - VITAZ- Oncology

Sint-Niklaas, Belgium

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

Wilrijk, Belgium

IRCCS--Ospedale Bellaria-Bologna

Bologna, Italy

AUSL - Ospedale Infermi

Faenza, Italy

Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

AUSL -Ospedale Umberto I

Lugo, Italy

Istituto Clinico Humanitas

Milan, Italy

IRCCS - Fondazione Istituto Nazionale dei Tumori

Milan, Italy

Azienda Sanitaria Locale Napoli 1 Centro

Naples, Italy

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

Ravenna, Italy

Azienda ospedaliero Univ Policlinico Umberto I

Rome, Italy

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

Barcelona, Spain

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

Barcelona, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario San Carlos

Madrid, Spain

Kantonsspital Aarau

Aarau, Switzerland

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

Bellinzona, Switzerland

Inselspital - Inselspital

Bern, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

UniversitaetsSpital Zurich

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05815927