System Maintenance Notice

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Studies

Interventional Recruiting Phase 3

NCT06809322 on ClinicalTrials.gov

Vorasidenib Maintenance for IDH Mutant Astrocytoma

Official title: Vorasidenib as Maintenance Treatment After First-line Chemoradiotherapy in IDH-mutant Grade 2 or 3 Astrocytoma: a Placebo-controlled, Triple-blind, Randomized Phase III Study (VIGOR)

  • Sponsor: European Organisation for Research and Treatment of Cancer (Belgium)
  • Collaborators: Canadian Cancer Trials Group, Olivia Newton-John Cancer Research Institute
  • Enrollment: 468 (Estimated)
  • Study start: 2026-01-16 (Actual)
  • Primary completion: 2035-04-13 (Estimated)
  • Study completion: 2037-05-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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

Intervention / Treatment

  • Drug: Vorasidenib
  • Drug: Vorasidenib Placebo

Primary Outcome Measures

  • Progression-free survival (PFS) by local assessment (~7.7 years and 10.5 years from first patient in)
    Progression-free survival (PFS) will be defined as the number of days from date of enrolment to the date of earliest disease progression based on Response Assessment (RANO 2.0) or to the date of death due to any cause, if disease progression did not occur (the date of progression or death or censoring - date of enrolment + 1). Patients who received new anti-cancer therapy or cancer-related surgery or radiotherapy prior to progression or death will not be censored at the last assessment where the patient was documented as progression free prior to the new anti-cancer therapy or cancer-related surgery or radiotherapy, instead progression after start of new therapy or surgery will be considered a valid event for PFS.

Countries

Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Locations and Investigators

  • Hospices Civils De Lyon, Bron, France
    • Francois, Ducray
  • Assistance Publique Hopitaux De Paris, Paris, France
    • Alice, Laurenge-Leprince
  • Centre Hospitalier Universitaire De Bordeaux, Bordeaux, France
    • Charlotte, Bronnimann
  • Oncopole Claudius Regaud, Toulouse, France
    • Elizabeth, Cohen-Jonathan Moyal
  • Centre Hospitalier Regional De Marseille, Marseille, France
    • Emeline, Tabouret
  • Hospital Universitari Vall D Hebron, Barcelona, Spain
    • Maria, Vieito Villar
  • Hospital De La Santa Creu I Sant Pau, Barcelona, Spain
    • Oscar, Gallego Rubio
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Juan Manuel, Sepulveda
  • Amsterdam UMC Stichting, Amsterdam, Netherlands
    • Myra, van Linde
  • Academisch Ziekenhuis Maastricht, Maastricht, Netherlands
    • Ann, Hoeben
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Rotterdam, Netherlands
    • Maarten, Wijnenga
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino, Turin, Italy
    • Roberta, Ruda
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome, Italy
  • Istituto Oncologico Veneto, Padova, Italy
  • Instituto Di Ricovero E Cura A Carattere Scientifico, Bologna, Italy
    • Enrico, Franceschi
  • UZ Brussel, Jette, Belgium
    • Johnny, Duerinck
  • Universitair Ziekenhuis Gent, Gent, Belgium
    • Tom, Boterberg
  • UZ Leuven, Leuven, Belgium
    • Paul, Clement
  • Heidelberg University, Mannheim, Germany
    • Lukas, Bunse
  • Goethe University Frankfurt, Frankfurt Am Main, Germany
    • Michael, Burger
  • Universitaetsklinikum Regensburg AöR, Regensburg, Germany
    • Peter, Hau
  • Universitaetsklinikum Bonn AöR, Bonn, Germany
    • Ulrich, Herrlinger
  • Universitaetsklinikum Heidelberg AöR, Heidelberg, Germany
    • Antje, Wick
  • Masarykuv Onkologicky Ustav, Brno-Stred, Czechia
    • Tomas, Kazda
  • Medical University Of Vienna, Vienna, Austria
  • Medizinische Universitaet Innsbruck, Innsbruck, Austria
    • Christian, Freyschlag
  • Kepler Universitaetsklinikum GmbH, Linz, Austria
    • Annette, Leibetseder-Zeller

Study Officials