Title: A Randomized, Double-blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence – the PATHWay Study1

Principal Investigators: Tanguy Seiwert, MD, University of Chicago

Description: For this randomized, phase 2 study, researchers are evaluating whether intravenous pembrolizumab will improve progression-free survival (PFS) among patients with head and neck cancer at high risk of recurrence.

All enrolled patients will have squamous cell carcinoma of the head and neck treated with curative intent.

The study has 2 arms: in the first, patients will receive pembrolizumab 200 mg every 3 weeks for 1 year; in the second, patients will receive placebo intravenously every 3 weeks for 1 year.

The primary endpoint is 2-year PFS. Secondary outcomes include PFS in PD-L1-positive patients and overall survival.

The estimated enrollment is 100 patients.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02841748.

Status: This study is open and recruiting patients as of July 14, 2017.

This study is sponsored by the University of Chicago.

Reference

  1. Clinicaltrials.gov. A randomized, double-blind phase II study of adjuvant pembrolizumab versus placebo in head and neck cancers at high risk for recurrence- the PATHWay study.  NCT02841748. https://clinicaltrials.gov/ct2/show/NCT02841748. Accessed July 14, 2017.