NCT02648997

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Meningiomas

Interventions

Type	Name	Description
DRUG	Nivolumab - 240 mg	240 mg every 2 weeks
DRUG	Ipilimumab - 1 mg/kg	1 mg/kg every 3 weeks
DRUG	Nivolumab - 480 mg	480 mg once every 4 weeks
DRUG	Nivolumab - 3 mg/kg	3 mg/kg every 3 weeks
RADIATION	External Beam RT	IMRT, 3D-CRT, or proton-beam radiation therapy
DRUG	Nivolumab - 1 mg/kg	1 mg/kg every 3 weeks
DRUG	Ipilimumab - 3 mg/kg	3 mg/kg every 3 weeks

Timeline

• Start date: 2016-03-01
• Primary completion: 2024-12-01
• Completion: 2026-06-01
• First posted: 2016-01-07
• Last updated: 2026-01-26
• Results posted: 2026-01-26

Locations

1 site across 1 country: United States