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

Glioblastoma Clinical Trial

Official title:
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)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02866747
Study type Interventional
Source Institut Claudius Regaud
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date January 17, 2017
Completion date April 2026
View Details
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