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

Conditions

• Astrocytoma, IDH-Mutant, Grade 3

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT/VMAT
• Volume Modulated Arc Therapy — RADIATION
  Undergo IMRT/VMAT
• Pencil Beam Scanning — RADIATION
  Undergo PBS
• Intensity-Modulated Proton Therapy — PROCEDURE
  Undergo IMPT
• Temozolomide — DRUG
  Given PO
• Vorasidenib — DRUG
  Given PO
• Placebo Administration — DRUG
  Given PO
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Questionnaire Administration — OTHER
  Ancillary Studies

Study Details

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.

Key Dates

Start date

Jul 20, 2026

Status verified

Jun 2026

Primary completion

May 31, 2033

Completion

Jan 31, 2040

Study Design

Enrollment

408 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Arm I (temozolomide, placebo)
  Patients receive IMRT/VMAT or PBS or IMPT QD on Monday-Friday for 33 fractions. Starting 4 weeks after radiotherapy, patients receive temozolomide PO QD on days 1-5 and placebo PO QD on days 1-28 of each cycle. Cycles of combination treatment repeat every 28 days for up to 12 months and placebo alone repeats every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the study.
• Experimental: Arm II (temozolomide, vorasidenib)
  Patients receive IMRT/VMAT or PBS or IMPT QD on Monday-Friday for 33 fractions. Starting 4 weeks after radiotherapy, patients receive temozolomide PO QD on days 1-5 and vorasidenib PO QD on days 1-28 of each cycle. Cycles of combination treatment repeat every 28 days for up to 12 months and vorasidenib alone repeats every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the study.

Primary Outcome Measure

Progression free survival (PFS) by blinded independent central review (BICR) [ Time Frame: assessed up to 10 years ]

Central Contacts

• Alexandra Alexandra LeVasseur
  773-834-4518
  [email protected]

Locations (75)

Find similar trials in Duarte, CA

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