Nivolumab for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:Gliomas are the most common malignant brain tumors. Some have certain changes (mutations) in the genes IDH1 or IDH2. If there are a high number of mutations in a tumor, it is called hypermutator phenotype (HMP). The drug nivolumab helps the immune system fight cancer. Researchers think it can be more effective in patients with IDH1 or IDH2 mutated gliomas with HMP. They will test gliomas with and without HMP.Objectives:To see if nivolumab stops tumor growth and prolongs the time that the tumor is controlled.Eligibility:Adults 18 years or older with IDH1 or IDH2 mutated gliomasDesign:Participants will be screened with:Medical historyPhysical examHeart, blood, and pregnancy testsReview of symptoms and activity levelsBrain magnetic resonance imaging (MRI). Participants will lie in a cylinder that takes pictures in a strong magnetic field.Tumor samplesParticipants will get the study drug in 4-week cycles. They will get it through a small plastic tube in a vein (IV) on days 1 and 15 of cycles 1-4. For cycles 5-16, they will get it just on day 1.On days 1 and 15 of each cycle, participants will repeat some or all screening tests.After cycle 16, participants will have 3 follow-up visits over 100 days. They will answer health questions, have physical and neurological exams, and have blood tests. They may have a brain MRI.Participants whose disease did not get worse but who finished the study drug within 1 year of treatment may have imaging studies every 8 weeks for up to 1 year.Participants will be called or emailed every 6 months with questions about their health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on a corticosteroid dose greater than dexamethasone 1 mg per day or its equivalent, and you cannot be receiving any other investigational agents.
Is Nivolumab safe for humans?
How is the drug Nivolumab unique for treating brain cancer?
What data supports the effectiveness of the drug Nivolumab for brain cancer?
Research shows that Nivolumab, used for lung cancer with brain metastases, has shown some positive effects in the brain, with one complete and one partial response in patients. This suggests it might help in treating brain cancer, but more research is needed to confirm its effectiveness specifically for brain cancer.811121314
Who Is on the Research Team?
Jing Wu, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults over 18 with IDH1 or IDH2 mutated gliomas are eligible for this trial. They must have adequate organ function, be able to undergo MRI scans, and not be pregnant or breastfeeding. Participants should not have a history of severe allergies to monoclonal antibodies, active infections, certain autoimmune diseases, or other cancers within the last three years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab in 4-week cycles, with IV administration on days 1 and 15 for cycles 1-4, and on day 1 for cycles 5-16
Follow-up
Participants have 3 follow-up visits over 100 days, including health questions, physical and neurological exams, blood tests, and possibly a brain MRI
Long-term follow-up
Participants whose disease did not progress may have imaging studies every 8 weeks for up to 1 year, and will be contacted every 6 months for health updates
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor