Last updated on March 2017

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


Brief description of study

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: - Arm A (control arm): Radiation therapy alone (17 patients) - Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab (33 patients)

Clinical Study Identifier: NCT02866747

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Augustin MERVOYER, MD

Institut de Cancerologie de L'Ouest
Angers, France
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Antoine CARPENTIER, MD

Hopital Avicenne
Bobigny, France
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Dinu STEFAN, MD

Centre Francois Baclesse
Caen, France
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Gilles TRUC, MD

Centre Georges Francois Leclerc
Dijon, France
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Marie CHARISSOUX, MD

Institut Regional Du Cancer de Montpellier
Montpellier, France
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Loïc FEUVRET, MD

Hopital Pitie Salpetriere
Paris, France
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Pierre VERELLE, MD

Institut Curie
Saint Cloud, France
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Georges NOEL, MD

Centre Paul Strauss
Strasbourg, France
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Elizabeth MOYAL-JONATHAN COHEN, MD,PhD

Institut Claudius Regaud
Toulouse, France
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Frédéric D'HERMAIN, MD

Institut Gustave Roussy
Villejuif, France
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