NCT05815927

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oligometastatic Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab: 400mg Q6W up to 2 years (i.e 17 cycles).
RADIATION	stereotattic 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.

Timeline

• Start date: 2025-05-23
• Primary completion: 2027-07-15
• Completion: 2030-03-30
• First posted: 2023-04-18
• Last updated: 2026-02-02

Locations

26 sites across 4 countries: Belgium, Italy, Spain, Switzerland