An Open-Label Phase II Study of Nivolumab in Adult Participants With Progessive/ Recurrent Meningioma

Meningiomas Clinical Trial

Official title: An Open-Label Phase II Study of Nivolumab in Adult Participants With Progressive/Recurrent Meningioma

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This research is a Phase II clinical trial, which means it will test the safety and effectiveness of nivolumab alone (Cohort 1) or in combination with ipilimumab (Cohort 2). Both nivolumab and ipilimumab are antibodies (types of human protein) that work to stop tumor cells from growing and multiplying by immunotherapy. Immunotherapy is trying to have the body's own immune system work against tumor cells. Nivolumab and ipilimumab have both been used in other research studies and information from those other research studies suggests that these interventions may help to stop Meningioma cells from growing. Nivolumab is FDA approved to treat other types of cancers, but the FDA (the U.S. Food and Drug Administration) has not yet approved this intervention for this type of cancer. The FDA has not approved the combination of nivolumab and ipilimumab for your specific disease, but it has been approved for other uses. ;

Related Conditions & MeSH terms

• Meningioma
• Meningiomas

• NCT number: NCT02648997
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: David A Reardon, MD
• Phone: 617-632-2166
• Email: david_reardon@dfci.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2016
• Completion date: September 2025