Title: Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN)1
Principal Investigators: Jonathan D. Schoenfeld, MD, MPH, Dana-Farber Cancer Institute
Description: For this non-randomized, phase 2 trial (ClinicalTrials.gov Identifier: NCT03085719), researchers are evaluating the safety and efficacy of high or high and low radiation dosages combined with pembrolizumab for patients with advanced or metastatic head and neck cancer.
Patients will be assigned to receive high dose radiation and pembrolizumab or high dose plus low dose radiation and pembrolizumab. High radiation dosages will be administered in 3 fractions; low doses will be administered in 2 fractions.
The primary outcome is overall response rate; secondary outcomes include overall survival, progression-free survival, and rate of adverse events.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03085719.
Status: This study is open and recruiting patients as of May 9, 2017.
This study is sponsored by Dana-Farber Cancer Institute in collaboration with Merck Sharpe & Dohme Corp.
- Clinicaltrials.gov. Targeting PD-1 therapy resistance with focused high or high and low dose radiation in SCCHN. NCT03085719. https://clinicaltrials.gov/ct2/show/NCT03085719. Accessed May 9, 2017.