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

Brief description of study

The purpose of the study is to examine the safety when combining nivolumab with or without ipilimumab (two different types of immunotherapy drugs) with radiosurgery (a type of radiation therapy) for recurrent intracranial meningioma. We are looking at the tolerability and efficacy of giving nivolumab (with or without ipilimumab) along with radiosurgery. We would like to see if the combination treatment may be better or worse than the standard approach of radiosurgery alone. The study drugs nivolumab and ipilimumab are investigational, which means that they have not been approved for this condition by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.

Clinical Study Identifier: s20-01430
ClinicalTrials.gov Identifier: NCT03604978
Principal Investigator: Sylvia C. Kurz.

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