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

Sponsor
Institut Claudius Regaud
Study ID
NCT02866747
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated stereotactic radiation therapy — RADIATION
  • Durvalumab — DRUG

Study Details

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

Key Dates

Start date
Jan 17, 2017
Status verified
Apr 2026
Primary completion
Nov 2, 2024
Completion
Nov 2, 2024

Study Design

Enrollment
108 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: radiation therapy alone
    Hypofractionated stereotactic radiation therapy (hFSRT) 24 Gray (Gy), 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 of the radiotherapy (RT), Day 3 RT and Day 5 RT.
  • Experimental: Arm B: combined treatment
    hFSRT 24 Gy, 8 Gy per fraction preferentially at 80% isodose (60 to 90 % accepted), 3 fractions scheduled on Day 1 RT, Day 3 RT and Day 5 RT, combined with Durvalumab infusion: first administration of Durvalumab\* on Day 5 RT (i.e. the same day after the last fraction of radiation, corresponding to the Day 1 for Durvalumab treatment) and then administration of Durvalumab 1500 milligrams (mg) every four weeks. \* Dosing 750 mg or 1500 mg, according to the recommended combination schema determined in phase I.

Primary Outcome Measure

Phase I: Dose Limiting Toxicities (DLT) incidence [ Time Frame: 8 months ]

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