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Study identifier: NCT05815927 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer

Condition: Oligometastatic Squamous Cell Carcinoma of the Head and Neck  ·  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

PhasePhase 3
Planned participants200
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

EORTC HQ  ·  +32 2 774 16 11  ·  eortc@eortc.org

Always discuss trial participation with your own doctor first.

Locations (30)

Cliniques Universitaires Saint-LucBrussels, BelgiumRecruiting
CHU Helora Pole Hospitalier Jolimont - Hopital JolimontHaine-Saint-Paul, BelgiumNot Yet Recruiting
AZ Groeninge Kortrijk - Campus KennedylaanKortrijk, BelgiumRecruiting
CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL NamurNamur, BelgiumRecruiting
VITAZ St Niklaas - VITAZ- OncologySint-Niklaas, BelgiumRecruiting
Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA)Wilrijk, BelgiumRecruiting
IRCCS--Ospedale Bellaria-BolognaBologna, ItalyNot Yet Recruiting
Azienda Ospedaliera Santa Croce E CarleCuneo, ItalyNot Yet Recruiting
Univ. of Florence -Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyRecruiting
Istituto Clinico HumanitasMilan, ItalyRecruiting
IRCCS - Fondazione Istituto Nazionale dei TumoriMilan, ItalyRecruiting
Azienda Sanitaria Locale Napoli 1 CentroNaples, ItalyNot Yet Recruiting

+ 18 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05815927