PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
This study aims to establish whether the combination of pembrolizumab (MK-3475) and
conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels
of acute and late toxicity in patients with stage IV LA-SCCHN. In particular, the study will
provide data on the levels of mucosal and cutaneous toxicity within the radiation fields, as
these are the primary acute toxicities associated with this treatment regimen. In addition,
toxicity outside the radiation portals (which may theoretically be exacerbated by radiation)
will be studied. However, all toxicity will be monitored. This study will also give an
indication of the activity of pembrolizumab in LA-SCCHN because we are deliberately selecting
a group of patients with high- and intermediate-risk disease who have a significant chance of
experiencing loco-regional or systemic failure.
Phase:
Phase 1
Details
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborators:
Institute of Cancer Research, United Kingdom Merck Sharp & Dohme Corp.