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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 a Lung Cancer

Study category: Cancer

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Description

Subjects will receive treatment with nivolumab as a 30 minute IV infusion on Day 1 of a treatment cycle every two weeks (14 days). There will be no dose escalations or reductions allowed. Treatment may be delayed for up to a maximum of 2 weeks from the scheduled re-treatment date. Subjects may be dosed no less than 12 days from the previous dose.

Details
Age

Adult

Eligibility

In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged > 18 years 4. A current or ex-smoker with a > 30 pack-year history of smoking and mild or worse sputum cytologic atypia, OR history of non-small cell lung cancer (stage I, II, or IIIA) with > 10 pack-year history of smoking and no evidence of active disease at least 1 year after definitive treatment, OR history of head and neck cancer (stage I, II, III, or IVA) with > 10 pack-year history of smoking and no evidence of active disease at least 1 year after definitive treatment. An ex-smoker is defined as no tobacco use in the prior 12 months 5. Endobronchial dysplasia (score > 4) on screening bronchoscopy 6. Total granulocyte count > 1500 7. Platelet count > 100,000 8. Serum creatinine < 1.5 mg/dL 9. Total bilirubin < 2.0 mg/dL 10. Transaminases and alkaline phosphatase < 2.5x upper limit of normal (ULN) 11. Albumin > 2.5 mg/dL 12. ECOG performance status &#8804; 1 (Appendix 1) 13. Participants must be able and willing to undergo three bronchoscopies: before, after four doses of nivolumab (8 weeks), and after 6 months

Detailed Eligibility: N/A

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Prevention

Locations

Rocky Mountain Regional VA Medical Center
University of Colorado Hospital

Principal Investigator
Robert Keith

Robert Keith

Study ID

Protocol Number: 17-1492

ClinicalTrials.gov: NCT03347838

Categories

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