NCT05815927Recrutement en cours

Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer

Résumé

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.

Critères d'inclusion

• 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.

Critères d'exclusion

• 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.

Contacts

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Statut: Recrutement en cours
Phase: Phase 3
Type d'étude: Interventionnelle
Pays: Suisse, Italie, Belgique, Espagne
Promoteur: European Organisation for Research and Treatment of Cancer - EORTC(Réseau / coopérateur)
N° de protocole: EORTC-2014-HNCG
Pathologies: Oligometastatic Squamous Cell Carcinoma of the Head and Neck
Interventions: Médicament, Radiothérapie

Traitements évalués

Pembrolizumab
stereotattic ablation radiotherapy (SABR)

Collaborateurs

Swiss Cancer Institute, Merck Sharp & Dohme LLC

Lieux · 17

Bern, SuisseInselspital - InselspitalRecrute dans ce centre
Lucerne, SuisseLuzerner KantonsspitalRecrute dans ce centre
Zurich, SuisseUniversitaetsSpital ZurichRecrute dans ce centre
Florence, ItalieUniv. of Florence -Azienda Ospedaliero-Universitaria CareggiRecrute dans ce centre
Milan, ItalieIstituto Clinico HumanitasRecrute dans ce centre
Milan, ItalieIRCCS - Fondazione Istituto Nazionale dei TumoriRecrute dans ce centre
Rome, ItalieAzienda ospedaliero Univ Policlinico Umberto IRecrute dans ce centre
Brussels, BelgiqueCliniques Universitaires Saint-LucRecrute dans ce centre
Kortrijk, BelgiqueAZ Groeninge Kortrijk - Campus KennedylaanRecrute dans ce centre
Namur, BelgiqueCHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL NamurRecrute dans ce centre
Sint-Niklaas, BelgiqueVITAZ St Niklaas - VITAZ- OncologyRecrute dans ce centre
Wilrijk, BelgiqueZiekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA)Recrute dans ce centre
Barcelona, EspagneHospital Universitari Vall d'Hebron -Vall d'Hebron Institut OncologiaRecrute dans ce centre
Barcelona, EspagneICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)Recrute dans ce centre
Las Palmas de Gran Canaria, EspagneHospital Universitario de Gran Canaria Doctor NegrinRecrute dans ce centre
Madrid, EspagneHospital Universitario Ramon y CajalRecrute dans ce centre
Madrid, EspagneHospital Universitario San CarlosRecrute dans ce centre

Au total, dans le monde, 17 des 30 centres listés au registre recrutent ; les 13 autres ne recrutent pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 28 mai 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Autres identifiants

2023-504478-39-00 · autre identifiant
2023 · financement NIH

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.