drugset / Trial / NCT03347838
Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers
Phase 2
Active not recruiting
19 enrolled
University of Colorado, Denver
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to determine whether the PD-1 inhibitor (Programmed cell death protein 1) nivolumab improves premalignant bronchial dysplastic lesions in subjects that are at high risk for the development of lung cancer, including those with a prior smoking history, or history of lung cancer or head and neck cancer. The safety and tolerability of nivolumab will also be studied.
Timeline
- Start
- 2019-01-30
- Primary completion
- 2025-06-18
- Completion
- 2026-12-31
Outcome
Met primary endpoint
registry p = 0.03; Observed response rate 0.526 (95% CI 0.32 to 1); Fisher Exact NCT03347838 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |