The main goal of VIGOR is to demonstrate that vorasidenib maintenance therapy improves locally assessed progression-free survival (PFS) from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO Grade 2 or 3 astrocytoma following the completion of first-line chemoradiotherapy.
The primary endpoint is Progression-free survival (PFS), as assessed locally from the date of enrolment using the RANO 2.0 criteria.
In this a comparative, randomized (1:1), triple blinded, multicentre phase III superiority trial with one stopping rule for efficacy and futility after end of enrolment, participants in the experimental arm will receive vorasidenib orally once daily at a dose of 40 mg in continuous 28-day cycles while participants in the control arm will receive a matched oral placebo once daily in continuous 28-day cycles
Before participant's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
Age ≥ 18 years
Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment
Documented IDH1 or IDH2 mutation based on local testing of tumour tissue
Presence of 1p19q co-deletion, per local assessment.
Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment
Last chemotherapy dose of first line chemoradiotherapy less than 6 weeks or more than 12 weeks before enrolment
Prior therapy with an IDH inhibitor or IDH vaccine
European Organisation for Research and Treatment of Cancer - EORTC
Lead sponsor
Canadian Cancer Trials Group
Collaborator
Olivia Newton-John Cancer Research Institute
Collaborator