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Vorasidenib Maintenance for IDH Mutant Astrocytoma

Study acronym: VIGOR
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 5 of 17 entries
    • Study description revised
    • Site details revised at 7 of 59 sites
  2. Trial sites expanded: 43 → 59 locations
    • Trial sites expanded: 33 → 43 locations
    v14
  3. Study sites: 33 to 43v13
  4. Site details revised at 1 of 33 sitesv12
  5. Site details revised at 1 of 33 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 3 of 33 sitesv10
  2. Site details revised at 2 of 33 sitesv9
  3. Site details revised at 4 of 33 sitesv8
  4. Site details revised at 7 of 33 sitesv7
  5. Site details revised at 5 of 33 sitesv6
  6. Site details revised at 2 of 33 sitesv5
  7. Site details revised at 1 of 33 sitesv4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 5, 2025 to Jan 16, 2026
    • Site details revised at 33 of 33 sites
    • Collaborators revised (2)
    v3
  9. Study sites: 0 to 33v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
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
(from sponsor)		 IDH-mutant Grade 2 or 3 Astrocytoma
Related terms Astrocytoma
Enrollment 468 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov