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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03347838
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 30, 2019
Status verified
Dec 2025
Primary completion
Jun 18, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab Injection [Opdivo]
    240 mg IV every 2 weeks for 4 doses

Primary Outcome Measure

Improvement in Endobronchial Histology [ Time Frame: 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Denver VA HospitalDenverColorado80220-

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By research site
University of Colorado Anschutz Medical Campus· Aurora, CODenver VA Hospital· Denver, CO

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