NCT02829931

Hypofractionated Stereotactic Irradiation With Nivolumab, Ipilimumab and Bevacizumab in Patients With Recurrent High Grade Gliomas

Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) Combined With Nivolumab, Ipilimumab and Bevacizumab in Patients With Recurrent High Grade Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety, and tolerability of nivolumab, ipilimumab, and bevacizumab given in combination with hypofractionated stereotactic re-irradiation of recurrent high grade gliomas.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
RADIATION	Hypofractionated Stereotactic Irradiation	Hypofractionated Stereotactic Irradiation (HFSRT) prior to nivolumab.
DRUG	Nivolumab	Nivolumab intravenously (IV): 240 mg every (q) 3 weeks x 4 months followed by 480 mg X 4 months.
DRUG	Bevacizumab	Bevacizumab intervenously (IV): 15 mg/kg every (q) 3 weeks when given with Ipilumumab and Nivolumab combination. Dose changed to 10mg/kg every 2 weeks when given with Nivolumab only.
DRUG	Ipilimumab	Ipilimumab 1mg/kg intervenously (IV) 200 mg (5 mg/mL) every (q) 3 weeks for 4 months.

Timeline

• Start date: 2016-08-22
• Primary completion: 2021-08-11
• Completion: 2022-11-22
• First posted: 2016-07-12
• Last updated: 2023-01-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study