61 Participants Needed

Nivolumab for Brain Cancer

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JW
Overseen ByJing Wu, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Nivolumab, also known as Opdivo, is generally safe for humans, but it can cause rare side effects like encephalitis (inflammation of the brain), which may lead to symptoms such as confusion or weakness. These side effects are treatable with steroids if recognized early.12345

How is the drug Nivolumab unique for treating brain cancer?

Nivolumab is unique because it is an immune checkpoint inhibitor that helps the body's immune system attack cancer cells, and it has shown activity in brain metastases from other cancers, despite the challenge of penetrating the blood-brain barrier.678910

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?

JW

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

Patient must be able to tolerate an MRI study with intravenous gadolinium contrast
I can care for myself but may need occasional help.
My organs and bone marrow are working well.
See 4 more

Exclusion Criteria

Pregnant women or breastfeeding mothers
I do not have any uncontrolled illnesses.
History of severe hypersensitivity reaction to any monoclonal antibody
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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

64 weeks
16 visits (in-person)

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

14 weeks
3 visits (in-person)

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

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nivolumab
Trial Overview The trial is testing Nivolumab's effectiveness on brain tumors with specific genetic mutations (IDH1/IDH2). It aims to see if it can stop tumor growth in patients with these mutations both with and without a high number of additional mutations known as HMP.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: 1/NivolumabExperimental Treatment1 Intervention

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

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Approved in United States as Opdivo for:
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Approved in European Union as Opdivo for:
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Approved in Canada as Opdivo for:
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Approved in Switzerland as Opdivo for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Nivolumab, an anti-PD-1 immunotherapy, was associated with immune-related encephalitis in a 60-year-old woman with recurrent head and neck cancer, highlighting a potential serious side effect of this treatment.
Despite the occurrence of immune-related toxicities, including encephalitis and hypothyroidism, the patient achieved a complete radiologic response one year after stopping nivolumab, demonstrating the efficacy of immunotherapy in managing advanced cancer.
Autoimmune-related encephalitis during treatment with nivolumab for advanced head and neck cancer: a case report.Guidi, A., Violati, M., Blasi, M., et al.[2022]
In a retrospective study of five patients with advanced non-small cell lung cancer (NSCLC) and new or progressing brain metastases, nivolumab showed promising intracranial activity, with one complete and one partial response observed, and stabilization of leptomeningeal carcinomatosis in another patient.
Nivolumab was well-tolerated, with no severe treatment-related adverse events reported, suggesting a favorable safety profile for patients with CNS metastases from NSCLC.
Intracranial response to nivolumab in NSCLC patients with untreated or progressing CNS metastases.Dudnik, E., Yust-Katz, S., Nechushtan, H., et al.[2022]
In a phase III trial, nivolumab significantly improved health-related quality of life (HRQoL) and disease-related symptoms compared to docetaxel in patients with advanced non-squamous non-small cell lung cancer, with improvements noted at multiple time points (weeks 12, 24, 30, and 42).
Patients receiving nivolumab experienced a longer time to first deterioration in HRQoL compared to those treated with docetaxel, indicating a more favorable safety profile and sustained symptom relief.
Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057.Reck, M., Brahmer, J., Bennett, B., et al.[2019]

Citations

Autoimmune-related encephalitis during treatment with nivolumab for advanced head and neck cancer: a case report. [2022]
Intracranial response to nivolumab in NSCLC patients with untreated or progressing CNS metastases. [2022]
Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. [2019]
Systemic and Intracranial Outcomes With First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC and Baseline Brain Metastases From CheckMate 227 Part 1. [2023]
Real-world experience of nivolumab in the treatment of poor performance status patients with advanced non-small cell lung cancer. [2022]
A Case Report of Steroid Responsive Nivolumab-Induced Encephalitis. [2018]
Neurologic Serious Adverse Events Associated with Nivolumab Plus Ipilimumab or Nivolumab Alone in Advanced Melanoma, Including a Case Series of Encephalitis. [2018]
Nivolumab-Associated Acute Demyelinating Encephalitis: A Case Report and Literature Review. [2020]
Association between immune-related adverse events and prognosis in patients with metastatic renal cell carcinoma treated with nivolumab. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Nivolumab-Induced Encephalitis in Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Circulating Immune Cell and Outcome Analysis from the Phase II Study of PD-L1 Blockade with Durvalumab for Newly Diagnosed and Recurrent Glioblastoma. [2023]
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]
Intracranial antitumor responses of nivolumab and ipilimumab: a pharmacodynamic and pharmacokinetic perspective, a scoping systematic review. [2020]
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
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