NCT03532295

Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

Safety and Efficacy Study of Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators propose to combine retifanlimab with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). The investigators hypothesize that this combination provides a powerful synergy between RT and immune modulators to produce more robust anti-tumor immune response, induce tumor regression and improve overall survival.

Conditions

• Glioma
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Epacadostat	-All BID doses will be taken in the morning and evening, approximately 12 hours apart
DRUG	Bevacizumab	-The first infusion will be over the course of 90 minutes; if tolerated, the second infusion will be over the course of 60 minutes; if tolerated, all subsequent infusions will be over 30 minutes
RADIATION	Radiation therapy	-The gross tumor maximum diameter (to be irradiated) to be \</= 6 cm in the first 6 patients. If more than 1 target is irradiated, then the sum of all the target maximum diameters should be \</= 6 cm. No more than 3 separate targets for RT is allowed.
DRUG	Retifanlimab	-Will be supplied by Incyte

Timeline

• Start date: 2020-04-20
• Primary completion: 2024-07-26
• Completion: 2025-10-31
• First posted: 2018-05-22
• Last updated: 2025-11-21
• Results posted: 2025-08-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study