Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06809322

Vorasidenib Maintenance for IDH Mutant Astrocytoma

Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-03-31

468

Participants Needed

33

Research Sites

593 weeks

Total Duration

On this page

Sponsors

E

European Organisation for Research and Treatment of Cancer - EORTC

Lead Sponsor

C

Canadian Cancer Trials Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Vorasidenib Maintenance for IDH Mutant Astrocytoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.

Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 33 locations

1

Medical University of Innsbruck

Innsbruck, Austria

Not Yet Recruiting

2

Kepler University Hospital - Neuromed campus

Linz, Austria

Actively Recruiting

3

Medical University of Vienna

Vienna, Austria

Actively Recruiting

4

Universitair Ziekenhuis Brussel

Brussels, Belgium

Actively Recruiting

5

Ghent University Hospital

Ghent, Belgium

Actively Recruiting

6

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

Actively Recruiting

7

Masaryk Memorial Cancer Institute

Brno, Czechia

Not Yet Recruiting

8

Universitary hospital Bordeaux France

Bordeaux, France

Not Yet Recruiting

9

CHU Lyon - Hopital neurologique Pierre Wertheimer

Lyon, France

Not Yet Recruiting

10

Marseille APHM

Marseille, France

Not Yet Recruiting

11

Assistance Publique Hopitaux de Paris APHP - Sorbonne

Paris, France

Not Yet Recruiting

12

Oncopole Claudius Regaud, IUCT-Oncopole

Toulouse, France

Not Yet Recruiting

13

Universitaskliniken Bonn

Bonn, Germany

Not Yet Recruiting

14

University Hospital Frankfurt -Senckenberg Institute of Neurooncology

Frankfurt, Germany

Not Yet Recruiting

15

NNeurology department heidelberg

Heidelberg, Germany

Not Yet Recruiting

16

Mannheim University Hospital

Mannheim, Germany

Actively Recruiting

17

Universitaetsklinikum Regensburg

Regensburg, Germany

Not Yet Recruiting

18

Bellaria Hospital, IRCCS Istituto delle Scienze Neurologiche - AUSL di Bologna

Bologna, Italy

Not Yet Recruiting

19

Veneto Institute of Oncology

Padova, Italy

Not Yet Recruiting

20

Sapienza University

Roma, Italy

Not Yet Recruiting

21

AOU Citta della Salute e della Scienza di Torino

Torino, Italy

Not Yet Recruiting

22

Amsterdam UMC location VUMC

Amsterdam, Netherlands

Not Yet Recruiting

23

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Actively Recruiting

24

Erasmus MC

Rotterdam, Netherlands

Actively Recruiting

25

Hospital de Sant Pau i La Santa Creu

Barcelona, Spain

Not Yet Recruiting

26

Vall de Hebron Hospital

Barcelona, Spain

Actively Recruiting

27

Hospital Universitario 12 de Octubre

Madrid, Spain

Actively Recruiting

28

University Hospital Basel

Basel, Switzerland

Not Yet Recruiting

29

University Hospital Zurich

Zurich, Switzerland

Not Yet Recruiting

30

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Not Yet Recruiting

31

The Christie NHS Foundation Trust

Manchester, United Kingdom

Not Yet Recruiting

32

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Not Yet Recruiting

33

Royal Marsden Hospital

Surrey Quays, United Kingdom

Not Yet Recruiting

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Research Team

E

EORTC HQ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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