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

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 us

Trial Details

NCT ID
NCT07215910
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Intensity-Modulated Radiation Therapy
  • Volume Modulated Arc Therapy
  • Pencil Beam Scanning
  • Intensity-Modulated Proton Therapy
  • Temozolomide
  • Vorasidenib
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Orange, California, United States|33.78779,-117.85311
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Newark, Delaware, United States|39.68372,-75.74966
  • Bloomington, Illinois, United States|40.4842,-88.99369

Key Eligibility Criteria

  • STEP 0: Histologic diagnosis of astrocytoma, IDH-mutant (central nervous system \[CNS\] WHO grade 3)
  • STEP 0: Available diagnostic slides (hematoxylin and eosin staining method \[H\&E\] and immunohistochemical stains for central review)
  • STEP 0: Tissue available for central biomarker testing (CDKN2A/B and1p/19q co-deletion \[all patients\], and IDH1/IDH2 \[if needed\])
  • STEP 1: Centrally-confirmed diagnosis of astrocytoma, IDH-mutant (CNS WHO grade 3)

For full eligibility, visit ClinicalTrials.gov.

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