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Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer

StatusRecruiting
PhasePhase 3
Started2026-06-24
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v4
Trial sites expanded: 97 → 121 locations
Start dateestimated 2026-07-20→confirmed 2026-06-24
2026-08-04
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 82 → 97 locations
2026-07-01
minor
Study Status, Contacts/Locations v2
Trial sites expanded: 75 → 82 locations
2026-06-15
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2025-10-20→2026-07-20
Study sites0→75
2025-10-09
minor
Original filing
This phase III trial compares the effect of vorasidenib to placebo in combination with usual treatment, temozolomide, in treating patients with newly diagnosed grade 3 astrocytoma after radiation. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Vorasidenib citrate blocks the proteins made by the mutated IDH1 and IDH2 genes, which may help keep tumor cells from growing. It is a type of enzyme inhibitor and a type of targeted therapy. Adding vorasidenib to the usual treatment, temozolomide, may be more effective than temozolomide alone in treating patients with newly diagnosed grade 3 astrocytoma after radiation therapy.
Trial Details
NCT Number NCT07215910
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Astrocytoma, IDH-Mutant, Grade 3
Enrollment 408 participants
Start Date 2026-06-24
Primary Completion 2033-05-31 (estimated)
Study Completion 2040-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-02