drugset / Trial / NCT02819752

PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

NCT02819752 ↗

Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2017-07-12
Primary completion
2019-11-28
Completion
2019-11-28

Outcome

Outcome not reported

Stopped (Business): “funding pulled”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 100 mg —
Subject Pembrolizumab Monoclonal antibody 200 mg —
Background Carboplatin Small molecule 5 unknown —
Background Cisplatin Other / unclassified 100 mg/m2 —