Vorasidenib Maintenance for IDH Mutant Astrocytoma

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: IDH-mutant Grade 2 or 3 Astrocytoma

In brief

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 facts

Study ID

NCT06809322

Run by

European Organisation for Research and Treatment of Cancer - EORTC

People needed

468

Starts

2026-01-16

Expected to finish

2037-05-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Erasmus MC — Rotterdam, Netherlands (enrolling)
• Hospital de Sant Pau i La Santa Creu — Barcelona, Spain (enrolling)
• Vall de Hebron Hospital — Barcelona, Spain (enrolling)
• Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
• U.Z. Leuven - Campus Gasthuisberg — Leuven, Belgium (enrolling)
• University Hospital Zurich — Zurich, Switzerland (enrolling)
• Masaryk Memorial Cancer Institute — Brno, Czechia (enrolling)
• Universitary hospital Bordeaux France — Bordeaux, France (enrolling)
• CHU Lyon - Hopital neurologique Pierre Wertheimer — Lyon, France (enrolling)
• Kepler University Hospital - Neuromed campus — Linz, Austria (enrolling)
• Assistance Publique Hopitaux de Paris APHP - Sorbonne — Paris, France (enrolling)
• Medical University of Vienna — Vienna, Austria (enrolling)
• Universitaskliniken Bonn — Bonn, Germany (enrolling)
• University Hospital Frankfurt -Senckenberg Institute of Neurooncology — Frankfurt, Germany (enrolling)
• NNeurology department heidelberg — Heidelberg, Germany (enrolling)
• Mannheim University Hospital — Mannheim, Germany (enrolling)
• Universitaetsklinikum Regensburg — Regensburg, Germany (enrolling)
• Bellaria Hospital, IRCCS Istituto delle Scienze Neurologiche - AUSL di Bologna — Bologna, Italy (enrolling)
• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)
• Ghent University Hospital — Ghent, Belgium (enrolling)
• AOU Citta della Salute e della Scienza di Torino — Torino, Italy (enrolling)
• Amsterdam UMC location VUMC — Amsterdam, Netherlands (enrolling)
• Academisch Ziekenhuis Maastricht — Maastricht, Netherlands (enrolling)
• Royal Marsden Hospital — Surrey Quays, United Kingdom
• Marseille APHM — Marseille, France

Full record on ClinicalTrials.gov

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