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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |