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Vorasidenib Maintenance for IDH Mutant Astrocytoma

NCT06809322 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2026-05-22

No results posted yet for this study

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

Conditions

  • IDH-mutant Grade 2 or 3 Astrocytoma

Interventions

DRUG

Vorasidenib

Vorasidinib will be administered orally once daily at a dose of 40 mg in continuous 28-day cycles

DRUG

Vorasidenib Placebo

Matched oral vorasidenib placebo will be administered once daily in continuous 28-day cycles

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Olivia Newton-John Cancer Research Institute

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Matthias Preusser · Universitaetsklinikum Wien - AKH uniklinieken, Vienna, Austria.

  • Marjolein Geurts · Brain Tumour Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2035-04-13
Completion
2037-05-31

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809322 on ClinicalTrials.gov