Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer
Status:
Not yet recruiting
Trial end date:
2029-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC