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UM1 10186 Nivo +/- Ipi with SRS in Meningioma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if it is safe to combine nivolumab with or without ipilimumab (two different types of immunotherapy drugs) with radiosurgery (a type of radiation therapy) for your type of recurrent brain tumor. We are looking at the side effects of giving patients nivolumab (with or without ipilimumab) along with radiosurgery.

What is the Condition Being Studied?

Meningioma

Who Can Participate in the Study?

Adults with meningioma that have been previously treated with radiation.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Get either the study drug nivolumab for up to 12 months along with a type of radiation therapy called stereotactic radiosurgery at the beginning of the study (3 radiation treatments)
OR
- Get nivolumab and stereotactic radiosurgery plus another study drug, ipilimumab

- Have routine MRI and blood tests
- Have thyroid testing done every 8 weeks

Study Details

Full Title
A Phase I/II Study of Nivolumab plus or minus Ipilimumab in Combination with Multi-fraction Stereotactic Radiosurgery for Recurrent High-grade Radiation-relapsed Meningioma (10186)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00101451
NCT:NCT03604978
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698