Trials / Active Not Recruiting
Active Not RecruitingNCT02841748
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
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.
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | 200mg, every three weeks, iv, x 1 year |
| DRUG | Placebo | iv, every three weeks, x 1 year |
Timeline
- Start date
- 2017-05-10
- Primary completion
- 2026-06-20
- Completion
- 2026-06-25
- First posted
- 2016-07-22
- Last updated
- 2025-10-01
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02841748. Inclusion in this directory is not an endorsement.