Concomitant Immune Check Point Inhibitor With Radiochemotherapy in Head And Neck Cancer
Status:
Recruiting
Trial end date:
2023-10-31
Target enrollment:
Participant gender:
Summary
Background: Locally advanced head and neck cancer (HNC) is a challenge as, in spite of
initial good control with chemoradiation, the majority of patients fails systemically. In the
last 2 years, immune check points inhibitors (mainly Programmed Death (PD)-1 inhibitors) were
approved for metastatic/recurrent HNC. The favorable toxicity profile and durable responses
was the main benefit of these drugs along the scope of cancers they were approved for.
Aim of the study and methods: This will be a phase II non-randomized trial to define safety
and efficacy of combining the PD-1 inhibitor pembrolizumab given concomitantly with the usual
standard of care chemoradiation/bioradiation for locally advanced non-nasopharyngeal HNC.
Primary end point will be assessment of toxicity and tolerability while the secondary end
points will be response rates (RR) and progression free survival (PFS)