NCT02866747

A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma

A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part. The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part. Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms: * Arm A (control arm): Radiation therapy alone * Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab

Conditions

• Glioblastoma

Interventions

Type	Name	Description
RADIATION	Hypofractionated stereotactic radiation therapy
DRUG	Durvalumab

Timeline

• Start date: 2017-01-17
• Primary completion: 2024-11-02
• Completion: 2024-11-02
• First posted: 2016-08-15
• Last updated: 2026-04-14

Locations

10 sites across 1 country: France