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Clinical Trials in Germany / NCT06809322
Recruiting Phase 3

Vorasidenib Maintenance for IDH Mutant Astrocytoma

NCT06809322 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2026-01-16
Last updated
2026-09-10

Condition(s) studied

IDH-mutant Grade 2 or 3 Astrocytoma

Investigational drug(s) / intervention(s)

Vorasidenib →Vorasidenib Placebo

Vorasidenib: Vorasidinib will be administered orally once daily at a dose of 40 mg in continuous 28-day cycles

Vorasidenib Placebo: Matched oral vorasidenib placebo will be administered once daily in continuous 28-day cycles

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Flinders Medical Centre / Southern Adelaide Local Health Network Bedford Park Australia Not Yet Recruiting
Chris O'Brien LifeHouse Camperdown Australia Not Yet Recruiting
Austin Hospital Heidelberg Australia Not Yet Recruiting
Royal Hobart Hospital Hobart Australia Not Yet Recruiting
Liverpool Hospital Liverpool Australia Not Yet Recruiting
Peter MacCallum Cancer Centre Melbourne Australia Not Yet Recruiting
the Alfred hospital Melbourne Australia Not Yet Recruiting
Sir Charles Gairdner Hospital Nedlands Australia Not Yet Recruiting
Royal North Shore Hospital St Leonards Australia Not Yet Recruiting
Princess Alexandra Hospital Woolloongabba Australia Recruiting
Medical University of Innsbruck Innsbruck Austria Recruiting
Kepler University Hospital - Neuromed campus Linz Austria Recruiting
Medical University of Vienna Vienna Austria Recruiting
Universitair Ziekenhuis Brussel Brussels Belgium Recruiting
Ghent University Hospital Ghent Belgium Recruiting
U.Z. Leuven - Campus Gasthuisberg Leuven Belgium Recruiting
Arthur J.E. Child Comprehensive Cancer Centre Calgary Alberta Not Yet Recruiting
Cross Cancer Institute Edmonton Alberta Not Yet Recruiting
BC Cancer Agency - Vancouver Vancouver British Columbia Not Yet Recruiting
CancerCare Manitoba Winnipeg Manitoba Recruiting
QEII Health Sciences Centre Capital District Health Authority Halifax Nova Scotia Not Yet Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario Not Yet Recruiting
Kingston Health Sciences Centre Kingston Ontario Not Yet Recruiting
London Health Sciences Centre Research Inc. London Ontario Not Yet Recruiting
Ottawa Hospital Research Institute Ottawa Ontario Not Yet Recruiting
Odette Cancer Centre Sunnybrook Health Sciences Centre Toronto Ontario Not Yet Recruiting
University Health Network Princess Margaret Cancer Centre Toronto Ontario Not Yet Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal Montreal Quebec Not Yet Recruiting
Montreal Neurological Institute and Hospital James Administration Building Montreal Quebec Not Yet Recruiting
CIUSSS NIM - Hôpital du Sacré-Cœur de Montréal Montreal Quebec Not Yet Recruiting
Hotel-Dieu de Quebec Québec Quebec Not Yet Recruiting
CIUSSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec Not Yet Recruiting
Masaryk Memorial Cancer Institute Brno Czechia Recruiting
Universitary hospital Bordeaux France Bordeaux France Recruiting
CHU Lyon - Hopital neurologique Pierre Wertheimer Lyon France Recruiting
Marseille APHM Marseille France Recruiting
Assistance Publique Hopitaux de Paris APHP - Sorbonne Paris France Recruiting
Oncopole Claudius Regaud, IUCT-Oncopole Toulouse France Recruiting
Universitaskliniken Bonn Bonn Germany Recruiting
University Hospital Frankfurt -Senckenberg Institute of Neurooncology Frankfurt Germany Recruiting

+ 19 more sites — see the full list on the official registry below.

More European Organisation for Research and Treatment of Cancer - EORTC trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06809322 on ClinicalTrials.gov ↗ ← All trials in Germany