Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 28, 2015

Primary Completion Date

September 13, 2018

Study Completion Date

August 9, 2021

Conditions
Malignant Glioma
Interventions
RADIATION

Hypofractionated Stereotactic Irradiation (HFSRT)

Radiation therapy treatment (FSRT) which will be given to participants over 5 days.

DRUG

Pembrolizumab

"Dose Escalation: The dose of pembrolizumab will be escalated per schema in a 3+3 fashion. The starting dose (i.e., dose level 1) will be 100 mg.~Dose Expansion: The pembrolizumab dose used in the dose expansion cohort will be maximum tolerated dose (MTD) determined from the dose escalation phase."

DRUG

Bevacizumab

Initial cycle of bevacizumab must start within 10 days of registering to the trial. It will be given concurrent with radiation therapy. Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. Doses will be adjusted if there is a \> 10% change in weight.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02313272 - Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas | Biotech Hunter | Biotech Hunter