NCT03367715

Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma

A Phase II, Open-label, Single Arm Trial of Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, phase II trial of nivolumab, ipilimumab and short-course radiation therapy in adult patients with newly diagnosed, MGMT unmethylated GBM with the primary objective of determining the overall survival at 1 year.

Conditions

• MGMT-unmethylated Glioblastoma (GBM)
• GBM

Interventions

Type	Name	Description
DRUG	Nivolumab	study treatment on Day 1 with one dose of nivolumab 3 mg/kg
DRUG	Ipilimumab	study treatment on Day 1 with one dose of ipilimumab 1mg/kg
RADIATION	Radiation Therapy (RT)	total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.

Timeline

• Start date: 2018-02-07
• Primary completion: 2021-05-20
• Completion: 2022-03-17
• First posted: 2017-12-11
• Last updated: 2022-07-01
• Results posted: 2022-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study