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

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

August 22, 2016

Primary Completion Date

August 11, 2021

Study Completion Date

November 22, 2022

Conditions
Malignant Glioma
Interventions
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.

Trial Locations (2)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

43210

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02829931 - Hypofractionated Stereotactic Irradiation With Nivolumab, Ipilimumab and Bevacizumab in Patients With Recurrent High Grade Gliomas | Biotech Hunter | Biotech Hunter