drugset / Trial / NCT02841748

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 ↗

Phase 2 Completed 100 enrolled University of Chicago
RandomizedParallel-groupTriple-blindTreatment

Summary

A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in order to potentially improve progression free survival in a squamous cell carcinoma of the head and neck cohort at high-risk for recurrence.

Timeline

Start
2017-05-10
Primary completion
2025-02-11
Completion
2025-10-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Pembrolizumab vs Placebo; p = 0.067; NCT02841748 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous