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Vorasidenib as daily maintenance therapy for adults with IDH‑mutant grade 2–3 astrocytoma

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)

Phase 3 Interventional European Organisation for Research and Treatment of Cancer - EORTC · NCT06809322

This trial will test whether taking daily vorasidenib after chemoradiotherapy delays tumor progression compared with placebo in adults with IDH‑mutant grade 2 or 3 astrocytoma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment468 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC Research network
Drugs / interventionschemotherapy
Locations33 sites (Innsbruck and 32 other locations)
Trial IDNCT06809322 on ClinicalTrials.gov

What this trial studies

This is a randomized, triple‑blind phase 3 trial that assigns participants 1:1 to oral vorasidenib 40 mg daily or matched placebo in continuous 28‑day cycles following completion of first‑line radiotherapy and adjuvant chemotherapy. The primary endpoint is locally assessed progression‑free survival using RANO 2.0 criteria, with one interim stopping rule for efficacy and futility after enrollment. Eligible patients are adults with an integrated diagnosis of IDH‑mutant CNS5 WHO grade 2 or 3 astrocytoma who have undergone at least one surgery and completed standard radiotherapy and temozolomide or PCV chemotherapy. Multiple academic centers in Europe are participating and the trial is coordinated by the EORTC with international collaborators.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed IDH1/2‑mutant WHO CNS5 grade 2 or 3 astrocytoma who have had at least one prior surgery and completed standard radiotherapy followed by temozolomide or PCV, and who meet organ function requirements, would be ideal candidates.

Not a fit: Patients without an IDH1/2 mutation, with WHO grade 4 disease, who have not completed first‑line chemoradiotherapy, or who have poor organ function are unlikely to qualify or benefit from this maintenance approach.

Why it matters

Potential benefit: If successful, vorasidenib maintenance could delay tumor recurrence and extend the time patients remain progression‑free after standard first‑line treatment.

How similar studies have performed: Early‑phase trials of vorasidenib showed promising biological activity and some radiographic responses in IDH‑mutant gliomas, but definitive phase 3 evidence is not yet established.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Innsbruck and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions IDH-mutant Grade 2 or 3 AstrocytomaAstrocytomaIDH-mutant grade 2 or 3VorasidenibPlacebo- controlledTriple-blindedPhase III study
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.