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Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers

NCT03347838 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-12-12

Study results available
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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.

Conditions

  • Bronchial Dysplasia
  • Tobacco Smoking
  • History of Non-Small Cell Lung Cancer
  • History of Head and Neck Cancer

Interventions

DRUG

Nivolumab

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

Sponsors & Collaborators

Principal Investigators

  • Robert Keith, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2025-06-18
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03347838 on ClinicalTrials.gov