Immunotherapy for Meningioma
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?
How is the drug Nivolumab unique in treating meningioma?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants in Cohort 2 receive external beam radiation therapy (IMRT, 3D-CRT, or proton-beam)
Treatment
Cohort 1 receives nivolumab monotherapy; Cohort 2 receives nivolumab and ipilimumab combination therapy followed by nivolumab monotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- External Beam RT
- Nivolumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- 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
- 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
- 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
- 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
Bristol-Myers Squibb
Industry Sponsor
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
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania