Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer

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.