Vorasidenib Maintenance for IDH Mutant Astrocytoma

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT06809322
Phase
PHASE3
Status
Recruiting
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Conditions

  • IDH-mutant Grade 2 or 3 Astrocytoma

Eligibility Criteria

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

Interventions

  • Vorasidenib — DRUG
    Vorasidinib will be administered orally once daily at a dose of 40 mg in continuous 28-day cycles
  • Vorasidenib Placebo — DRUG
    Matched oral vorasidenib placebo will be administered once daily in continuous 28-day cycles

Study Details

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

Key Dates

Start date
Jan 16, 2026
Status verified
May 2026
Primary completion
Apr 13, 2035
Completion
May 31, 2037

Study Design

Enrollment
468 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Participants will receive vorasidenib orally once daily at a dose of 40 mg in continuous 28-day cycles up to 5 years or until disease progression, unacceptable toxicity, or withdrawal of patient consent.
  • Placebo Comparator: Control arm
    Participants will receive a matched oral vorasidenib placebo once daily in continuous 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of patient consent for up to 5 years.

Primary Outcome Measure

Progression-free survival (PFS) by local assessment [ Time Frame: ~7.7 years and 10.5 years from first patient in ]

Central Contacts