NCT06809322Recrutement en cours
Vorasidenib Maintenance for IDH Mutant Astrocytoma
Résumé
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
Critères d'inclusion
• 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.
Critères d'exclusion
• 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.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, Australie, Belgique, Canada, Tchéquie, Pays-Bas, Espagne, Royaume-Uni
- Promoteur
- European Organisation for Research and Treatment of Cancer - EORTC(Réseau / coopérateur)
- N° de protocole
- EORTC -2427-BTG
- Pathologies
- IDH-mutant Grade 2 or 3 Astrocytoma
- Interventions
- Médicament
Traitements évalués
- Vorasidenib
- Vorasidenib Placebo
Collaborateurs
Canadian Cancer Trials Group, Olivia Newton-John Cancer Research Institute
Lieux · 35
- Basel, SuisseUniversity Hospital BaselRecrute dans ce centre
- Zurich, SuisseUniversity Hospital ZurichRecrute dans ce centre
- Bordeaux, FranceUniversitary hospital Bordeaux FranceRecrute dans ce centre
- Lyon, FranceCHU Lyon - Hopital neurologique Pierre WertheimerRecrute dans ce centre
- Marseille, FranceMarseille APHMRecrute dans ce centre
- Paris, FranceAssistance Publique Hopitaux de Paris APHP - SorbonneRecrute dans ce centre
- Toulouse, FranceOncopole Claudius Regaud, IUCT-OncopoleRecrute dans ce centre
- Bonn, AllemagneUniversitaskliniken BonnRecrute dans ce centre
- Frankfurt, AllemagneUniversity Hospital Frankfurt -Senckenberg Institute of NeurooncologyRecrute dans ce centre
- Heidelberg, AllemagneNNeurology department heidelbergRecrute dans ce centre
- Mannheim, AllemagneMannheim University HospitalRecrute dans ce centre
- Regensburg, AllemagneUniversitaetsklinikum RegensburgRecrute dans ce centre
- Bologna, ItalieBellaria Hospital, IRCCS Istituto delle Scienze Neurologiche - AUSL di BolognaRecrute dans ce centre
- Padova, ItalieVeneto Institute of OncologyRecrute dans ce centre
- Torino, ItalieAOU Citta della Salute e della Scienza di TorinoRecrute dans ce centre
- Innsbruck, AutricheMedical University of InnsbruckRecrute dans ce centre
- Linz, AutricheKepler University Hospital - Neuromed campusRecrute dans ce centre
- Vienna, AutricheMedical University of ViennaRecrute dans ce centre
- Woolloongabba, AustraliePrincess Alexandra HospitalRecrute dans ce centre
- Brussels, BelgiqueUniversitair Ziekenhuis BrusselRecrute dans ce centre
- Ghent, BelgiqueGhent University HospitalRecrute dans ce centre
- Leuven, BelgiqueU.Z. Leuven - Campus GasthuisbergRecrute dans ce centre
- Winnipeg, CanadaCancerCare ManitobaRecrute dans ce centre
- Toronto, CanadaOdette Cancer Centre Sunnybrook Health Sciences CentreRecrute dans ce centre
- Toronto, CanadaUniversity Health Network Princess Margaret Cancer CentreRecrute dans ce centre
- Brno, TchéquieMasaryk Memorial Cancer InstituteRecrute dans ce centre
- Amsterdam, Pays-BasAmsterdam UMC location VUMCRecrute dans ce centre
- Maastricht, Pays-BasAcademisch Ziekenhuis MaastrichtRecrute dans ce centre
- Rotterdam, Pays-BasErasmus MCRecrute dans ce centre
- Barcelona, EspagneHospital de Sant Pau i La Santa CreuRecrute dans ce centre
Au total, dans le monde, 35 des 59 centres listés au registre recrutent ; les 24 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 7 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 5 autres lieux
Autres identifiants
- 2024-519404-27-00 · n° CTIS
- CE.10 · autre identifiant
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.