Phase I/II clinical trial - Système Nerveux Central

Système Nerveux Central
Ouvert depuis le: 10.04.2023
Site: Saint-Cloud
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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).
Description de l'essai
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 (local control rate) of the combined treatment in recurrent glioblastoma. In this Phase II part, patients will be assigned by randomization to one of the two following arms:;ÀArm A (control arm): Radiation therapy alone (17 patients);ÀArm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab (33 patients).