Title: 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 Carncinoma (HNSCC)1

Principal Investigators: Julie Bauman, NRG Oncology

Description: For this phase 1, dose-expansion trial, researchers are evaluating the safety, optimal dose, and efficacy of pembrolizumab combined with cisplatin and intensity-modulated radiation therapy (IMRT) among patients with head and neck cancer. Eligible patients much have stage III/IV/IVA/IVB squamous cell carcinoma.

This study has 1 arm: patients will receive intravenous cisplatin once weekly for 6 weeks followed by intravenous pembrolizumab every 3 weeks thereafter through week 21. IMRT will be administered during weeks 1 to 6.

The primary objective is to determine the optimal dosage of pembrolizumab based on dose-limiting toxicity. Secondary objectives include disease-free survival, toxicity, and the relationship between PD-L1 expression and disease-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02775812.

Status: This study is open and recruiting participants as of May 10, 2017.

This study is sponsored by the National Cancer Institute.

Reference

  1. Clinicaltrials.gov. Cisplatin, intensity-modulated radiation therapy, and pembrolizumab in treating patients with stage III-IV head and neck squamous cell carcinoma. NCT02775812. https://clinicaltrials.gov/ct2/show/NCT02775812. Accessed May 10, 2017.