Vorasidenib Maintenance for IDH Mutant Astrocytoma
Status:
NOT_YET_RECRUITING
Trial end date:
2037-05-31
Target enrollment:
Participant gender:
Summary
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
Phase:
PHASE3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators:
Canadian Cancer Trials Group Cooperative Trials Group for Neuro-Oncology (COGNO)