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TERMINATED
NCT02819752
PHASE1

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

Sponsor: Royal Marsden NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: Phase I Dose-escalation Study of PEmbrolizumab (MK3475) Anti-PD1 Immune Checkpoint Inhibitor Combined With Radical Chemoradiotherapy in Patients With Stage IV Squamous Cell Carcinoma of the Head and Neck

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2017-07-12

Completion Date

2019-11-28

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Pembrolizumab

RADIATION

Radiotherapy

Radiotherapy - Standard Treatment

DRUG

Chemotherapy

Chemotherapy - Standard Treatment

Locations (1)

Royal Marsden Hospital NHS Foundation Trust

London, United Kingdom