OncoMatch/Clinical Trials/NCT06809322
Vorasidenib Maintenance for IDH Mutant Astrocytoma
Is NCT06809322 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Vorasidenib for idh-mutant grade 2 or 3 astrocytoma.
Treatment: Vorasidenib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
Documented IDH1 or IDH2 mutation based on local testing of tumour tissue
Required: IDH2 mutation
Documented IDH1 or IDH2 mutation based on local testing of tumour tissue
Excluded: 1P19Q co-deletion
Presence of 1p19q co-deletion, per local assessment [excluded]
Disease stage
Required: Stage WHO CNS5 GRADE 2, WHO CNS5 GRADE 3 (WHO CNS5)
Excluded: Stage CNS5 WHO GRADE 4
Grade: 23 (WHO CNS5)
Integrated diagnosis of astrocytoma, IDH-mutant, WHO CNS5 grade 2 or 3, per local assessment
Performance status
WHO 0–2
Prior therapy
Must have received: surgery — glioma
At least 1 prior surgery for glioma (biopsy, partial resection, gross-total resection)
Must have received: radiation therapy — first-line standard of care
Completed first-line standard of care radiotherapy (minimum 50.4 Gy, photons or protons allowed)
Must have received: cytotoxic chemotherapy (temozolomide, PCV) — adjuvant
SoC adjuvant chemotherapy (i.e., either 4-12 cycles of temozolomide or 2-6 cycles of PCV)
Cannot have received: IDH inhibitor
Prior therapy with an IDH inhibitor or IDH vaccine
Cannot have received: IDH vaccine
Prior therapy with an IDH inhibitor or IDH vaccine
Lab requirements
Blood counts
absolute neutrophil counts ≥ 1.5 x 10^9/L, haemoglobin ≥ 9 g/dL, platelets 100 x 10^9/L.
Kidney function
serum creatinine ≤ 2.0 x ULN, or creatine clearance > 40 mL/min, as calculated based on CKD-EPI 2021 formula.
Liver 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); ALT and AST ≤ 1.5 x ULN; ALP ≤ 2.5 x ULN.
Adequate bone marrow function: absolute neutrophil counts ≥ 1.5 x 10^9/L, haemoglobin ≥ 9 g/dL, platelets 100 x 10^9/ 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); ALT and AST ≤ 1.5 x ULN; ALP ≤ 2.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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