133 Participants Needed

Nivolumab for Brain Cancer

Recruiting at 11 trial locations
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MP
Overseen ByMarta Penas-Prado, 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

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on a corticosteroid dose greater than physiologic replacement dosing (30 mg of cortisone per day or its equivalent). It's best to discuss your current medications with the trial team.

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 30 mg of cortisone per day or its equivalent, and you cannot be receiving any other investigational agents.

What data supports the idea that Nivolumab for Brain Cancer is an effective treatment?

The available research shows that Nivolumab, when used for non-small cell lung cancer (NSCLC) with brain metastases, has shown some positive results. In one study, out of five patients with brain metastases, one had a complete response and another had a partial response in the brain. This suggests that Nivolumab might have some effectiveness in treating brain-related conditions, although more research is needed to confirm its effectiveness specifically for brain cancer.12345

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 observed in patients. This suggests it might have potential benefits for brain cancer, but more research is needed.12345

What safety data exists for Nivolumab in treating brain cancer?

Nivolumab, also known as Opdivo, is associated with immune-related adverse events, including rare cases of encephalitis. Reports indicate that encephalitis occurs in 1% to 3% of treated cases and can be managed with steroids. Neurologic adverse events range from mild headaches to severe encephalitis, which is reversible with prompt treatment. While CNS toxicities are rare, they require early recognition and management to prevent severe outcomes.678910

What safety information is available for Nivolumab (Opdivo) in humans?

Nivolumab, also known as Opdivo, is generally safe for many people, but it can cause rare but serious side effects like encephalitis (inflammation of the brain). This condition can lead to symptoms such as confusion and weakness, but it is often treatable with steroids if caught early.678910

Is the drug Nivolumab (Opdivo) a promising treatment for brain cancer?

Nivolumab has shown promise in treating certain types of lung cancer and has some activity in brain metastases from melanoma, suggesting it might be a promising option for brain cancer. However, more specific research on brain cancer is needed to confirm its effectiveness.111121314

How does the drug Nivolumab work differently for brain cancer compared to other treatments?

Nivolumab is unique because it is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, which is different from traditional chemotherapy that directly kills cancer cells. Although it is primarily used for lung cancer, its potential to treat brain cancer is being explored, especially since it may have some ability to affect brain tumors despite the blood-brain barrier.111121314

What is the purpose of this trial?

Background:More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors.Objectives:To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread.Eligibility:Adults whose rare CNS tumor has returned.Design:Individuals will be screened:* Heart and blood tests* Physical and neurological exam* Hepatitis tests* Pregnancy test* MRI. They will lay in a machine that takes pictures.* Tumor tissue sample. This can be from a previous procedure.At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life.Individuals will get nivolumab in a vein every 2 weeks for up to 64 weeks.Individuals will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life.Genetic tests will be done on individuals' tumor tissue. Individuals will be contacted if any clinically important results are found.After treatment ends, individuals will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....

Research Team

BH

Byram H Ozer, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Adults with certain rare brain or spine tumors that have come back can join this trial. They must be over 18, in good health, and not on high steroid doses. Participants need to have had all COVID-19 shots, agree to use birth control if needed, and provide a tumor tissue sample. People who've had other cancers or severe illnesses, are pregnant or breastfeeding, allergic to the drug's ingredients, unable to get MRIs or vaccinated against COVID-19 can't join.

Inclusion Criteria

My diagnosis is one of the listed brain or central nervous system tumors.
Tumor tissue must be available for immunophenotyping by NCI Laboratory of Pathology
My cancer has grown despite treatment.
See 7 more

Exclusion Criteria

History of allergy to study drug components
I have previously received immunotherapy or specific cancer vaccines.
I do not have another cancer that could affect this treatment's safety or results.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive nivolumab intravenously every 2 weeks for cycles 1-2, then every 4 weeks for up to 64 weeks

64 weeks
Bi-weekly visits for first 2 cycles, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment with MRIs and neurological function tests

5 years
Every 8 weeks for 1 year, then every 3 months for 1 year, then every 4 months for 1 year, then every 6 months

Treatment Details

Interventions

  • Nivolumab
Trial Overview The trial is testing Nivolumab—an immunotherapy drug—given every two weeks through an IV for up to 64 weeks. It aims to see if it shrinks these rare CNS tumors or slows their growth. The study includes regular blood tests, MRIs every two months along with neurological function tests and quality of life surveys.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 1/Experimental TherapyExperimental Treatment1 Intervention
Individuals will receive nivolumab at standard dose of 240 mg IV every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses

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

🇺🇸
Approved in United States as Opdivo for:
  • Advanced or metastatic gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Hepatocellular carcinoma
  • Esophageal squamous cell carcinoma
🇪🇺
Approved in European Union as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
🇨🇦
Approved in Canada as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
🇨🇭
Approved in Switzerland as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

Nivolumab plus ipilimumab significantly improved overall survival in patients with metastatic non-small cell lung cancer (NSCLC), including those with baseline brain metastases, compared to chemotherapy, with a hazard ratio of 0.63 for those with brain metastases and 0.76 for those without.
At 5 years, patients with baseline brain metastases treated with nivolumab plus ipilimumab had higher rates of systemic (12%) and intracranial (16%) progression-free survival compared to chemotherapy (0% and 6%, respectively), and fewer developed new brain lesions (4% vs. 20%).
Systemic and Intracranial Outcomes With First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC and Baseline Brain Metastases From CheckMate 227 Part 1.Reck, M., Ciuleanu, TE., Lee, JS., et al.[2023]
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]

References

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]
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]
Real-world experience of nivolumab in the treatment of poor performance status patients with advanced non-small cell lung cancer. [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]
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]
Nivolumab-Induced Encephalitis in Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
A Case Report of Steroid Responsive Nivolumab-Induced Encephalitis. [2018]
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
Intracranial antitumor responses of nivolumab and ipilimumab: a pharmacodynamic and pharmacokinetic perspective, a scoping systematic review. [2020]
14.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]
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