CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 19 enrolled
Drug / intervention
Nivolumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03347838
NCT03347838Phase 2Active
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PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers With or Without a History of Lung Cancer

University of Colorado, Denver·interventional·Posted Nov 20, 2017·Updated Dec 12, 2025

In Brief

A Phase 2 clinical trial evaluating Nivolumab for Bronchial Dysplasia and 3 related conditions. Active but no longer recruiting, targeting 19 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchial Dysplasia, Tobacco Smoking, History of Non-Small Cell Lung Cancer, History of Head and Neck Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2Active
2018201920202021202220232024202520262027
First PostedNov 20, 2017
Enrollment StartJan 30, 2019
Primary CompletionJun 18, 2025
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 8.6 years ago

Interventions

Nivolumabdrug

Nivolumab is a human monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.