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NRG-HN003

NRG-HN003: A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)

Principal Investigator

Julie E. Bauman, MD, MPH

Primary Objective

To determine the recommended phase II schedule for the combination of MK-3475 (pembrolizumab) and standard, adjuvant cisplatin-radiotherapy in patients with high-risk, HPV-negative head and neck squamous cell carcinoma, based upon dose-limiting toxicity.

Patient Population

Patients with stage III-IVb, high-risk squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx; patients with oropharyngeal cancer must be p16-negative.

Target Accrual

56 patients

Status

Activated November 28, 2016

Protocol Documents and Forms

  • The protocol and related documents are available at NRG-HN003 (Enter CTEP IAM credentials to access NRG Oncology Member Login)

Copyright 2017 by NRG Oncology