40 Participants Needed

Immunotherapy for Meningioma

DA
Overseen ByDavid A Reardon, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Dana-Farber Cancer Institute
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

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that you should not be on high-dose systemic corticosteroids or other investigational agents. It's best to discuss your current medications with the study team to see if they are allowed.

What data supports the effectiveness of the drug Nivolumab for treating meningioma?

Research suggests that Nivolumab, a drug that helps the immune system fight cancer, has shown promise in shrinking meningiomas (a type of brain tumor) in some patients. Studies indicate that targeting PD-1, a protein that helps tumors evade the immune system, may be effective for treating aggressive meningiomas.12345

Is nivolumab (Opdivo) safe for use in humans?

Nivolumab, used in treating various conditions, has shown that 20% of patients experienced serious treatment-related side effects in a study for high-grade meningiomas. This suggests that while it can be effective, there are potential safety concerns that need to be considered.12367

How is the drug Nivolumab unique in treating meningioma?

Nivolumab is unique for treating meningioma because it is an immunotherapy drug that blocks PD-1, a protein that helps cancer cells evade the immune system, potentially making it effective for tumors that are resistant to traditional treatments like surgery and radiation.12378

What is the purpose of this trial?

This research study is studying targeted immunotherapies as a possible treatment for recurrent meningioma. The names of the study interventions involved in this study are nivolumab and ipilimumab.

Research Team

David Reardon, MD - Dana-Farber Cancer ...

David Reardon, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with recurrent meningioma, a type of brain tumor, who've tried radiation or other treatments without success can join. They must be able to follow the study plan and use birth control if needed. People with severe illnesses, recent surgeries, live vaccines taken recently, HIV/AIDS, certain cancers within 3 years, active infections needing IV treatment or known allergies to trial drugs cannot participate.

Inclusion Criteria

Agreement to follow instructions for contraception
I am able to care for myself but may not be able to do active work.
My meningioma is confirmed and has returned or is getting worse.
See 7 more

Exclusion Criteria

I have received CTLA-4 therapy before, as part of cohort 2.
I haven't taken drugs that weaken my immune system in the last 3 months.
Pregnancy or breastfeeding
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants in Cohort 2 receive external beam radiation therapy (IMRT, 3D-CRT, or proton-beam)

3-4 weeks

Treatment

Cohort 1 receives nivolumab monotherapy; Cohort 2 receives nivolumab and ipilimumab combination therapy followed by nivolumab monotherapy

6 months
Every 2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • External Beam RT
  • Nivolumab
Trial Overview The trial is testing different doses of Nivolumab alone or combined with Ipilimumab and/or external beam radiation therapy (RT) as potential treatments for progressive/recurrent meningioma. The goal is to see how well these immunotherapies work in controlling the disease.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Nivolumab in Combination with IpilimumabExperimental Treatment4 Interventions
* External Beam RT (IMRT, 3D-CRT, or proton-beam radiation therapy) * Followed by 4 cycles of Nivolumab (3 mg/kg every 3 weeks) + Ipilimumab (1 mg/kg every 3 weeks) * Followed by Nivolumab monotherapy (480 mg every 4 weeks).
Group II: Cohort 1 (original cohort): Nivolumab MonotherapyExperimental Treatment2 Interventions
Nivolumab monotherapy (240 mg every 2 weeks)

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?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

This case report presents the first evidence that nivolumab, an anti-PD-1 therapy, can significantly reduce the size of a refractory meningioma in a patient being treated for advanced lung cancer.
The findings suggest that PD-1 checkpoint inhibitors may be a promising treatment avenue for meningiomas, warranting further research into their efficacy in this type of brain tumor.
Regression of intracranial meningioma following treatment with nivolumab: Case report and review of the literature.Gelerstein, E., Berger, A., Jonas-Kimchi, T., et al.[2018]
In a phase 2 trial involving 25 patients with recurrent high-grade meningiomas, pembrolizumab (a PD-1 inhibitor) demonstrated promising efficacy, achieving a 6-month progression-free survival rate of 48% and a median progression-free survival of 7.6 months.
While 20% of patients experienced significant treatment-related adverse events (grade 3 or higher), the results indicate that pembrolizumab may be a viable treatment option for some patients with these aggressive tumors, warranting further investigation into the tumor microenvironment's role in treatment response.
Phase 2 study of pembrolizumab in patients with recurrent and residual high-grade meningiomas.Brastianos, PK., Kim, AE., Giobbie-Hurder, A., et al.[2022]

References

Regression of intracranial meningioma following treatment with nivolumab: Case report and review of the literature. [2018]
Activity of PD-1 blockade with nivolumab among patients with recurrent atypical/anaplastic meningioma: phase II trial results. [2022]
Efficient ADCC killing of meningioma by avelumab and a high-affinity natural killer cell line, haNK. [2020]
Systemic and local immunosuppression in patients with high-grade meningiomas. [2021]
Immune checkpoint inhibitor therapy for recurrent meningiomas: a retrospective chart review. [2022]
Phase 2 study of pembrolizumab in patients with recurrent and residual high-grade meningiomas. [2022]
Basis for Immunotherapy for Treatment of Meningiomas. [2023]
PD-L1 expression in meningiomas. [2018]
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