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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Astrocytoma, IDH-Mutant, Grade 3

In brief

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 facts

Study ID

NCT07215910

Run by

Alliance for Clinical Trials in Oncology

People needed

408

Starts

2026-07-20

Expected to finish

2040-01-01

Last updated by the study team

2026-08-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• STEP 1: Presence of IDH1 p.R132 or IDH2 p.172 mutation, confirmed by central review of immunohistochemical stain or molecular testing results, with central confirmation of equivocal results
• STEP 1: Absence of CDKN2A/B homozygous deletion by central testing
• STEP 1: Absence of whole arm 1p/19q co-deletion (i.e. intact 1p/19q) by central testing
• STEP 1: No evidence of spinal or leptomeningeal disease
• STEP 1: No prior chemotherapy, cranial irradiation, IDH-inhibitor therapy, radiotherapy, vaccine therapy, small-molecule therapy, or laser ablation
• STEP 1: Prior diagnostic surgery/resection/biopsy ≤ 6 months of registration
• STEP 1: Planned radiotherapy and adjuvant chemotherapy
• STEP 1: Age ≥ 12 years
• STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky performance status [KPS] ≥ 60%)
• STEP 1: Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
• STEP 1: Hemoglobin ≥ 9 g/dL
• STEP 1: Platelet count ≥ 100,000/mm\^3
• STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• For patients with Gilbert syndrome, total bilirubin ≤ 1.0 x ULN
• STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x ULN
• STEP 1: Alkaline phosphatase ≤ 2.5 x ULN
• STEP 1: Creatinine ≤ 2.0 x ULN or calculated (calc.) creatinine clearance > 40 mL/min
• For patients ≥ 18 years of age, calculated using the Cockcroft-Gault equation. For patients < 18 years of age, calculated using the Bedside Schwartz method:
• Age: 10 to < 13 years; Maximum Serum Creatinine (mg/dL): 1.2 (male) 1.2 (female)
• Age: 13 to < 16 years; Maximum Serum Creatinine (mg/dL): 1.5 (male) 1.4 (female)
• Age: ≥ 16 years; Maximum Serum Creatinine (mg/dL): 1.7(male) 1.4 (female)

Where it is running

• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States (enrolling)
• Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
• OSF Saint Joseph Medical Center — Bloomington, Illinois, United States (enrolling)
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States (enrolling)
• Illinois CancerCare-Canton — Canton, Illinois, United States (enrolling)
• Illinois CancerCare-Carthage — Carthage, Illinois, United States (enrolling)
• University of Illinois — Chicago, Illinois, United States (enrolling)
• Illinois CancerCare-Eureka — Eureka, Illinois, United States (enrolling)
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States (enrolling)
• Illinois CancerCare-Galesburg — Galesburg, Illinois, United States (enrolling)
• NorthShore University HealthSystem-Glenbrook Hospital — Glenview, Illinois, United States (enrolling)
• NorthShore University HealthSystem-Highland Park Hospital — Highland Park, Illinois, United States (enrolling)
• Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States (enrolling)
• Illinois CancerCare-Macomb — Macomb, Illinois, United States (enrolling)
• Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States (enrolling)
• Illinois CancerCare-Pekin — Pekin, Illinois, United States (enrolling)
• Illinois CancerCare-Peoria — Peoria, Illinois, United States (enrolling)
• OSF Saint Francis Radiation Oncology at Peoria Cancer Center — Peoria, Illinois, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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