Study on Nivolumab for Reversing Precancerous Lung Changes in High-Risk Smokers and Former Smokers
Sponsor: University of Colorado, Denver
ClinicalTrials ID:NCT03347838
This clinical trial is exploring whether the drug nivolumab can help improve precancerous lung changes in people at high risk for lung cancer, such as current or former smokers, or those with a history of lung or head and neck cancer. The study will also assess the safety of nivolumab.
Patient Parameters
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Program Overview
The aim of this study is to find out if nivolumab, a drug that blocks a protein called PD-1, can help improve precancerous changes in the lungs of people who are at high risk for developing lung cancer. This includes individuals with a history of heavy smoking or those who have had lung or head and neck cancer. The study will also look at how safe and tolerable nivolumab is for these patients.
Description
This study involves giving the drug nivolumab to patients who are at high risk for lung cancer to see if it can help reverse precancerous changes in the lungs. The study will enroll 18 participants initially, and if at least 7 show improvement, an additional 24 participants will be added, making a total of 42 participants. Nivolumab will be given through an IV every two weeks for a total of four doses over eight weeks. Participants will have a bronchoscopy, a procedure to look inside the lungs, at the start of the study, after two months, and after six months. The main goal is to see if there is a change in the lung condition from the start to six months. The study will also monitor the safety of nivolumab and look for any markers that might predict how well patients respond to the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must be a current or former smoker with a history of smoking more than 30 pack-years and have certain lung changes, or have had lung cancer or head and neck cancer with a history of smoking more than 10 pack-years and no active disease for at least a year.
- Must have specific lung changes seen during a bronchoscopy.
- Must have certain blood counts and organ function within normal limits.
- Must be able to undergo three bronchoscopies during the study.
- Must be willing to sign a consent form and follow study procedures.
Exclusion Criteria
- Cannot be currently receiving or have previously received certain immune therapies.
- Cannot be taking other experimental cancer treatments.
- Cannot have had certain allergic reactions to similar drugs.
- Cannot have certain heart conditions or bleeding disorders.
- Cannot have untreated or active hepatitis B or C, or low oxygen levels.
- Cannot have severe lung disease or recent chemotherapy or radiation.
- Cannot have suspicious findings on a CT scan without further evaluation.
- Cannot have other active cancers, except for certain skin cancers.
- Cannot have certain autoimmune diseases or require high doses of steroids.
- Cannot have a life expectancy of less than one year.
- Women must not be pregnant or breastfeeding and must use birth control.
- Must be able to give informed consent.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus | 80045 | Aurora | Colorado |
| Denver VA Hospital | 80220 | Denver | Colorado |
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