Actively Recruiting
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
Eligibility Criteria
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.
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
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here