RECRUITING Phase 3 ClinicalTrials.gov

Vorasidenib Maintenance for IDH Mutant Astrocytoma

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC • ClinicalTrials.gov ID: NCT06809322

Registry updated: 2026-10-07

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Description

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

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

Eligibility criteria

Inclusion Criteria: * Before participant's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations. * Age ≥ 18 years * Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment * Documented IDH1 or IDH2 mutation based on local testing of tumour tissue * At least 1 prior surgery for glioma (biopsy, partial resection, gross-total resection) * Completed first-line standard of care radiotherapy (minimum 50.4 Gy, photons or protons allowed) followed by SoC adjuvant chemotherapy (i.e., either 4-12 cycles of temozolomide or 2-6 cycles of PCV). * Adequate bone marrow function: absolute neutrophil counts ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets 100 x 109/ L. * Adequate renal function: serum creatinine ≤ 2.0 x ULN, or creatine clearance \> 40 mL/min, as calculated based on CKD-EPI 2021 formula. * Adequate hepatic function: * Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \> 3.0 × ULN or direct bilirubin ≥1.5 × ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 x ULN. * Alkaline phosphatase (ALP) ≤ 2.5 x ULN. * Recovered from any clinically relevant toxicity of the previous chemoradiotherapy cycle unless stable and manageable per investigator´s judgement * WHO performance status 0-2 * Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrollment. * Baseline brain MRI available, as defined in the schedule of assessments * Available FFPE tumour tissue from prior neurosurgery for central biobanking and translational research * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment. * Participants of childbearing / reproductive potential should use two adequate methods of birth control, including a highly effective method and a barrier method during the study treatment period and for at least 90 days after the last dose of treatment. Exclusion Criteria: * Presence of 1p19q co-deletion, per local assessment. * Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment * Last chemotherapy dose of first line chemoradiotherapy less than 6 weeks or more than 12 weeks before enrolment * Prior therapy with an IDH inhibitor or IDH vaccine * Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. * Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4 * Pregnancy or breastfeeding * Significant known active cardiac disease within 6 months before enrollment, including New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke. * Known hypersensitivity to any of the components of vorasidenib. * Ongoing use of medications that are CYP2C8, CYP2C9, CYP2C19, or CYP3A substrates with a narrow therapeutic index. Participants must be transferred to other medications before receiving the first dose of study drug. * Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted. • Known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential). * Inability or known contraindication to undergo contrast media MRI. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.

Conditions

IDH-mutant Grade 2 or 3 Astrocytoma

Locations

Flinders Medical Centre / Southern Adelaide Local Health Network — Bedford Park, Australia
Chris O'Brien LifeHouse — Camperdown, Australia
Austin Hospital — Heidelberg, Australia
Royal Hobart Hospital — Hobart, Australia
Liverpool Hospital — Liverpool, Australia
Peter MacCallum Cancer Centre — Melbourne, Australia
the Alfred hospital — Melbourne, Australia
Sir Charles Gairdner Hospital — Nedlands, Australia
Royal North Shore Hospital — St Leonards, Australia
Princess Alexandra Hospital — Woolloongabba, Australia
Medical University of Innsbruck — Innsbruck, Austria
Kepler University Hospital - Neuromed campus — Linz, Austria
Medical University of Vienna — Vienna, Austria
Universitair Ziekenhuis Brussel — Brussels, Belgium
Ghent University Hospital — Ghent, Belgium
U.Z. Leuven - Campus Gasthuisberg — Leuven, Belgium
Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
Cross Cancer Institute — Edmonton, Alberta, Canada
BC Cancer Agency - Vancouver — Vancouver, British Columbia, Canada
CancerCare Manitoba — Winnipeg, Manitoba, Canada
QEII Health Sciences Centre Capital District Health Authority — Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
Kingston Health Sciences Centre — Kingston, Ontario, Canada
London Health Sciences Centre Research Inc. — London, Ontario, Canada
Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
Odette Cancer Centre Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
University Health Network Princess Margaret Cancer Centre — Toronto, Ontario, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada
Montreal Neurological Institute and Hospital James Administration Building — Montreal, Quebec, Canada
CIUSSS NIM - Hôpital du Sacré-Cœur de Montréal — Montreal, Quebec, Canada
Hotel-Dieu de Quebec — Québec, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada
Masaryk Memorial Cancer Institute — Brno, Czechia
Universitary hospital Bordeaux France — Bordeaux, France
CHU Lyon - Hopital neurologique Pierre Wertheimer — Lyon, France
Marseille APHM — Marseille, France
Assistance Publique Hopitaux de Paris APHP - Sorbonne — Paris, France
Oncopole Claudius Regaud, IUCT-Oncopole — Toulouse, France
Universitaskliniken Bonn — Bonn, Germany
University Hospital Frankfurt -Senckenberg Institute of Neurooncology — Frankfurt, Germany
NNeurology department heidelberg — Heidelberg, Germany
Mannheim University Hospital — Mannheim, Germany
Universitaetsklinikum Regensburg — Regensburg, Germany
Bellaria Hospital, IRCCS Istituto delle Scienze Neurologiche - AUSL di Bologna — Bologna, Italy
Veneto Institute of Oncology — Padova, Italy
Sapienza University — Roma, Italy
AOU Citta della Salute e della Scienza di Torino — Torino, Italy
Amsterdam UMC location VUMC — Amsterdam, Netherlands
Academisch Ziekenhuis Maastricht — Maastricht, Netherlands
Erasmus MC — Rotterdam, Netherlands
Hospital de Sant Pau i La Santa Creu — Barcelona, Spain
Vall de Hebron Hospital — Barcelona, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
University Hospital Basel — Basel, Switzerland
University Hospital Zurich — Zurich, Switzerland
Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom
The Christie NHS Foundation Trust — Manchester, United Kingdom
Clatterbridge Cancer Centre — Metropolitan Borough of Wirral, United Kingdom
Royal Marsden Hospital — Surrey Quays, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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