NCT02313272

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

A Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab in Patients With Recurrent High Grade Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the addition of the investigation drug called pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can help with controlling the growth of tumors, in participants with recurrent high grade glioma.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-28
• Primary completion: 2018-09-13
• Completion: 2021-08-09
• First posted: 2014-12-10
• Last updated: 2023-10-23
• Results posted: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study