New drug aims to keep brain tumors at bay after standard therapy

NCT ID NCT06809322

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 12 times

Summary

This phase 3 trial tests whether the drug vorasidenib can delay tumor progression in people with IDH-mutant grade 2 or 3 astrocytoma after they finish initial chemoradiotherapy. About 468 participants will receive either vorasidenib or a placebo daily. The main goal is to see if vorasidenib extends the time before the tumor grows back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Vorasidenib
What this could lead to: If successful, vorasidenib could delay tumor regrowth after standard treatment, giving people with this brain cancer more time without progression.
What could go wrong: This is a phase 3 trial, but results are not yet known. The drug may not improve outcomes over placebo, and side effects could occur. It is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 468 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

May 2037

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

astrocytoma (excluding glioblastoma) astrocytoma, IDH-mutant, grade 2 astrocytoma, IDH-mutant, grade 3

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IDH-mutant grade 2 or 3 astrocytoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

59 sites in 12 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AOU Citta della Salute e della Scienza di Torino
RECRUITING

Torino, Italy
Academisch Ziekenhuis Maastricht
RECRUITING

Maastricht, Netherlands
Amsterdam UMC location VUMC
RECRUITING

Amsterdam, Netherlands
Arthur J.E. Child Comprehensive Cancer Centre
NOT_YET_RECRUITING

Calgary, Alberta, T2N 5G2, Canada
Assistance Publique Hopitaux de Paris APHP - Sorbonne
RECRUITING

Paris, France
Austin Hospital
NOT_YET_RECRUITING

Heidelberg, VIC 3084, Australia
BC Cancer Agency - Vancouver
NOT_YET_RECRUITING

Vancouver, British Columbia, V5Z 4E6, Canada
Bellaria Hospital, IRCCS Istituto delle Scienze Neurologiche - AUSL di Bologna
RECRUITING

Bologna, Italy
CHU Lyon - Hopital neurologique Pierre Wertheimer
RECRUITING

Lyon, France
CHUM-Centre Hospitalier de l'Universite de Montreal
NOT_YET_RECRUITING

Montreal, Quebec, H2X 0A9, Canada
CIUSSS NIM - Hôpital du Sacré-Cœur de Montréal
NOT_YET_RECRUITING

Montreal, Quebec, H4J 1C5, Canada
CIUSSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke
NOT_YET_RECRUITING

Sherbrooke, Quebec, J1H 5N4, Canada
CancerCare Manitoba
RECRUITING

Winnipeg, Manitoba, R3E 0V9, Canada
Chris O'Brien LifeHouse
NOT_YET_RECRUITING

Camperdown, NSW 2050, Australia
Clatterbridge Cancer Centre
NOT_YET_RECRUITING

Metropolitan Borough of Wirral, United Kingdom
Cross Cancer Institute
NOT_YET_RECRUITING

Edmonton, Alberta, T6G 1Z2, Canada
Erasmus MC
RECRUITING

Rotterdam, Netherlands
Flinders Medical Centre / Southern Adelaide Local Health Network
NOT_YET_RECRUITING

Bedford Park, SA 5042, Australia
Ghent University Hospital
RECRUITING

Ghent, Belgium
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, Spain
Hospital de Sant Pau i La Santa Creu
RECRUITING

Barcelona, Spain
Hotel-Dieu de Quebec
NOT_YET_RECRUITING

Québec, Quebec, G1R 2J6, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
NOT_YET_RECRUITING

Hamilton, Ontario, L8V 5C2, Canada
Kepler University Hospital - Neuromed campus
RECRUITING

Linz, Austria
Kingston Health Sciences Centre
NOT_YET_RECRUITING

Kingston, Ontario, K7L 2V7, Canada
Liverpool Hospital
NOT_YET_RECRUITING

Liverpool, NSW 2170, Australia
London Health Sciences Centre Research Inc.
NOT_YET_RECRUITING

London, Ontario, N6A 5W9, Canada
Mannheim University Hospital
RECRUITING

Mannheim, Germany
Marseille APHM
RECRUITING

Marseille, France
Masaryk Memorial Cancer Institute
RECRUITING

Brno, Czechia
Medical University of Innsbruck
RECRUITING

Innsbruck, Austria
Medical University of Vienna
RECRUITING

Vienna, Austria
Montreal Neurological Institute and Hospital James Administration Building
NOT_YET_RECRUITING

Montreal, Quebec, H3A 2B4, Canada
NNeurology department heidelberg
RECRUITING

Heidelberg, Germany
Odette Cancer Centre Sunnybrook Health Sciences Centre
NOT_YET_RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Oncopole Claudius Regaud, IUCT-Oncopole
RECRUITING

Toulouse, France
Ottawa Hospital Research Institute
NOT_YET_RECRUITING

Ottawa, Ontario, K1H 8L6, Canada
Peter MacCallum Cancer Centre
NOT_YET_RECRUITING

Melbourne, VIC 3000, Australia
Princess Alexandra Hospital
RECRUITING

Woolloongabba, QLD 4102, Australia
QEII Health Sciences Centre Capital District Health Authority
NOT_YET_RECRUITING

Halifax, Nova Scotia, B3H 1V7, Canada
Queen Elizabeth Hospital Birmingham
NOT_YET_RECRUITING

Birmingham, United Kingdom
Royal Hobart Hospital
NOT_YET_RECRUITING

Hobart, TAS 7000, Australia
Royal Marsden Hospital
RECRUITING

Surrey Quays, United Kingdom
Royal North Shore Hospital
NOT_YET_RECRUITING

St Leonards, NSW 2065, Australia
Sapienza University
NOT_YET_RECRUITING

Roma, Italy
Sir Charles Gairdner Hospital
NOT_YET_RECRUITING

Nedlands, WA 6009, Australia
The Christie NHS Foundation Trust
RECRUITING

Manchester, United Kingdom
U.Z. Leuven - Campus Gasthuisberg
RECRUITING

Leuven, Belgium
Universitaetsklinikum Regensburg
RECRUITING

Regensburg, Germany
Universitair Ziekenhuis Brussel
RECRUITING

Brussels, Belgium
Universitary hospital Bordeaux France
RECRUITING

Bordeaux, France
Universitaskliniken Bonn
RECRUITING

Bonn, Germany
University Health Network Princess Margaret Cancer Centre
NOT_YET_RECRUITING

Toronto, Ontario, M5G 2M9, Canada
University Hospital Basel
RECRUITING

Basel, Switzerland
University Hospital Frankfurt -Senckenberg Institute of Neurooncology
RECRUITING

Frankfurt, Germany
University Hospital Zurich
RECRUITING

Zurich, Switzerland
Vall de Hebron Hospital
RECRUITING

Barcelona, Spain
Veneto Institute of Oncology
RECRUITING

Padova, Italy
the Alfred hospital
NOT_YET_RECRUITING

Melbourne, VIC 3000, Australia