Phase 1 Pembrolizumab, Cisplatin, and IMRT for Head and Neck Cancer
Researchers are evaluating the safety, optimal dose, and efficacy of pembrolizumab combined with cisplatin and IMRT among patients with head and neck cancer.
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.
- 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.