Clinical Trial

Vorasidenib Maintenance for IDH Mutant Astrocytoma

Study acronym: VIGOR
Recruiting Phase 3
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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
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-01-30; most recent amendment 2026-07-23.
Status change: Not Yet Recruiting → Recruiting 2026-01-30
Trial Details
NCT Number NCT06809322
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Canadian Cancer Trials Group, Olivia Newton-John Cancer Research Institute
Conditions IDH-mutant Grade 2 or 3 Astrocytoma
Enrollment 468 participants
Start Date 2026-01-16
Primary Completion 2035-04-13 (estimated)
Study Completion 2037-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11