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NCT03347838 · ClinicalTrials.gov registry record · Phase 2
Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers
A Phase 2 study of Tobacco Smoking and Bronchial Dysplasia, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 2
- Study locations
NCT03347838: Active Phase 2 study of Tobacco Smoking and Bronchial Dysplasia, sponsored by University of Colorado, Denver.
NCT03347838 is a Phase 2 study of Tobacco Smoking and Bronchial Dysplasia that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 19 participants, below the 477-participant average among 38 other Tobacco Smoking trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03347838, a Phase 2 study of Tobacco Smoking and Bronchial Dysplasia, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The primary endpoint is the dichotomous endpoint of whether a subject responds to PD-1 immune checkpoint inhibition using nivolumab. Response will be based on the 6-month change (difference between 6-month score and baseline score) in worst (i.e., maximum) histologic classification score, using the 2004 World Health Organization (WHO) classification scale for pre-invasive squamous lesions of the bronchus. The histologic classification consists of: normal (grade 1.0), reserve cell hyperplasia (gr
Conditions Studied
Interventions
- DRUG Nivolumab
Study Locations (2)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- Denver VA Hospital - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03347838 still lists
NCT03347838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 477-participant average among 38 other Tobacco Smoking trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Tobacco Smoking appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab is the first listed.
NCT03347838 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03347838 about?
NCT03347838 is a clinical study titled "Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers". 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 hi...
What is the current status of trial NCT03347838?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2019-01-30. Estimated completion is 2026-12-31.
What conditions does trial NCT03347838 study?
This clinical trial studies the following conditions: Tobacco Smoking, Bronchial Dysplasia, History of Non-Small Cell Lung Cancer, History of Head and Neck Cancer.
What interventions are being tested in trial NCT03347838?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT03347838?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03347838 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03347838's enrollment target sits among peer trials
19 33rd of 38 higher than 6 of 38 other Tobacco Smoking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Smoking trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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