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Nivolumab for Lung Cancer Prevention in Smokers
Study Summary
This trial will test whether the immunotherapy drug nivolumab can improve conditions in the airway of people at high risk for developing lung cancer. The safety of nivolumab will also be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
Media Library
- I do not have a condition that causes unusual bleeding.I have never been treated with immune checkpoint inhibitors.You have had allergic reactions to drugs that are similar to nivolumab.I do not have severe heart rhythm problems.If you have HIV, the researchers will decide if you can join the study based on your health and the study's needs.Your blood has low oxygen levels, even with extra oxygen.I have untreated hepatitis B or C with a detectable viral load.I've had cancer before, but it's been inactive for over a year, except for some skin or cervical cancers.I have an autoimmune disease but it's either type I diabetes, hypothyroidism needing hormone replacement, or a skin condition not needing systemic treatment.You are not expected to live for more than 1 year.You have significant abnormal changes in your airways found during a special lung exam.Your total granulocyte count is higher than 1500.Your blood platelet count is higher than 100,000.Your total bilirubin level is less than 2.0 mg/dL.Your liver enzymes are not more than 2.5 times the upper limit of normal.I have a history of serious heart issues that could affect undergoing certain medical procedures.I have severe lung disease with very low lung function.I have cancer, but not skin cancer or early-stage lung cancer found during a biopsy.I haven't taken high doses of steroids or other immune-weakening drugs in the last 2 weeks.I am unable to understand and agree to the study's details.I have had pneumonia or acute bronchitis for the last 2 weeks.I am fully active and can carry on all my pre-disease activities without restriction.I am willing to undergo three bronchoscopies as part of the study.You have smoked a lot in your lifetime and have certain lung or head and neck cancer history.Women who could become pregnant must have a negative pregnancy test within 4 weeks before starting nivolumab.I have been treated for lung inflammation with strong medications.Your blood creatinine level is less than 1.5 mg/dL.I am over 18 years old.I have lung disease that could affect my treatment.I had stage IIIA lung cancer treated only with chemoradiation, no surgery.My CT scan shows possible lung cancer, but I've been cleared of cancer after further tests.I have not had chemotherapy or chest radiation in the last year.Your albumin levels are higher than 2.5 mg/dL.
- Group 1: Nivolumab Injection [Opdivo]
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Nivolumab been cleared by the FDA?
"Nivolumab's Phase 2 status suggests that while there is some evidence of safety, none exists yet for efficacy. Therefore, it received a score of 2 from our team at Power."
How many test subjects are in this experiment?
"Affirmative, the clinical trial detailed on clinicaltrials.gov is recruiting patients at this time. This particular study was posted on December 6th, 2018 and updated November 4th, 2021. They are looking for 42 individuals total between 2 research sites."
Are people currently being signed up for this clinical trial?
"That is right. The clinical trial, which was created on December 6th 2018 and last updated November 4th 2021, is open and looking for 42 individuals at 2 sites."
Does this research project have an age limit for participants?
"As long as they are between 18-80 years old, individuals meet the age requirements for this clinical trial."
Nivolumab is most commonly given to treat which type of illness?
"While Nivolumab is most often used to fight cancer, it can also be effective in treating other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Is this a new or innovative clinical trial?
"Nivolumab has been under clinical investigation for a decade. The first official study was sponsored by Medarex and took place in 2010 with only 127 participants. After the initial Phase 1 approval, there are now 748 active studies involving nivolumab spanning 2349 cities and 50 countries."
How can I sign up to participate in this research project?
"This bronchial dysplasia study will allow 42 patients, both male and female, between the ages of 18-80 to participate. Patients must also be willing to comply with all procedures and be available for the entirety of the trial. Lastly, screening bronchoscopy must show endobronchial dysplasia (with a score >4)."
What other medical research has been conducted with Nivolumab?
"At the moment, 748 studies are ongoing that focus on Nivolumab. Out of those, 82 have reached Phase 3. However, most trials for this treatment Take place in Basel BE with 40405 other locations running related studies."
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