Clinical trial Recruiting at 176 sites Phase 3 Interventional Ages 12 and up

Vor a sid en ib + temozolomide after radiation for IDH-mutant astrocytoma (grade 3)

Official title: Phase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination With the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 Astrocytomas

Run by Alliance for Clinical Trials in Oncology · NCT07215910 · Data updated 2026-11-12

This phase 3 trial tests whether adding vorasidenib to the usual temozolomide after radiation helps people with newly diagnosed IDH-mutant astrocytoma (grade 3).

Quick facts

PhasePhase 3
Study typeInterventional
Ages12 Years and up
SexAll
Enrollment408 (estimated)
SponsorAlliance for Clinical Trials in Oncology
Academic / other
Drugs / interventionschemotherapy, prednisone, radiation
Locations177 sites (Phoenix, Arizona and 176 other locations)
StatusRecruiting
StartedJune 24, 2026
Main results expectedMay 31, 2033
Study endsJanuary 2040
Registry record updatedNovember 3, 2026
Trial IDNCT07215910 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with newly diagnosed IDH-mutant astrocytoma (WHO grade 3) after radiation who meet study biomarker and safety criteria.

Probably not a fit

Patients whose tumors do not respond to the combination or who experience intolerable side effects may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, controlled study, participants receive vorasidenib plus temozolomide after completing radiation, or placebo plus temozolomide. The primary goal is to see if the combination improves progression-free survival compared with temozolomide alone. Secondary goals include safety, overall survival, and tumor response rates assessed by standard criteria. Eligibility requires confirmed IDH-mutant astrocytoma (grade 3) with no 1p/19q co-deletion and no prior cranial irradiation or IDH-inhibitor therapy. Treatment centers include several large institutions in Arizona and California.

Why it matters

Potential benefit: If successful, the regimen could delay tumor progression and potentially extend survival for patients with this brain cancer.

How similar studies have gone: Prior studies in similar IDH-mutant brain tumors have shown mixed results; this trial tests a targeted approach in a well-defined group.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion 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)
* 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)
* STEP 1: Not pregnant and not nursing, because this study involves agents whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown

  \* Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required
* STEP 1: Women and men of reproductive potential should agree to abstain from sexual intercourse or use two highly effective methods of birth control, at least one of which must be a barrier method, throughout their participation in this study and for at least 90 days after the last dose of vorasidenib. Reproductive status and discussions about birth control measures should be documented in the patient's record. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of birth control. Highly effective forms of birth control are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, intrauterine hormone release systems, bilateral tubal ligation, condoms with spermicide, or male partner sterilization
* STEP 1: No severe or intercurrent illness, no active infection that requires systemic anti-infective therapy, and no active infection with an unexplained fever \> 38.5°C within 7 days prior to registration
* STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* STEP 1: Patients must be able to tolerate or undergo an MRI
* STEP 1: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* STEP 1: No significant active cardiac disease within 6 months prior to registration, including New York Heart Association Functional Classification class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke. To be eligible for this trial, patients should be class 2B or better
* STEP 1: No history of significant (grade ≥ 2) intratumoral or peri-tumoral hemorrhage
* STEP 1: No known active inflammatory gastrointestinal disease, chronic diarrhea, prior gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition causing an inability to swallow oral formulations of agents. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential)
* STEP 1: No known hypersensitivity to any of the components of vorasidenib or temozolomide
* STEP 1: No other acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or protocol therapy administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
* STEP 1: No concurrent use of other investigational agents
* STEP 1: No concurrent use of alternating tumor treating field (TTField) therapy
* STEP 1: No concurrent use of therapeutic doses of steroids for glioma. Concurrent use of physiologic doses of steroids (defined as equivalent of ≤ 10 mg prednisone daily) for medical conditions unrelated to glioma is allowed. Corticosteroids administered for reasons related to glioma should be used in the smallest dose possible to control symptoms of cerebral edema and mass effect and discontinued whenever possible.
* STEP 1: No concurrent use of warfarin sodium or any other Coumadin-derivative anticoagulant. Patients must be off Coumadin-derivative anticoagulants for at least 7 days prior to registration. Low molecular weight heparin (LMWH) and factor Xa inhibitors are allowed
* STEP 1: No concurrent use of strong and moderate CYP1A2 inhibitors, moderate CYP1A2 inducers, or CYP3A substrates where a minimal concentration change can reduce efficacy. Patients should be transferred to other medications prior to registration

Exclusion Criteria:

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Where it's running

  • Saint Joseph's Hospital and Medical Center
    Phoenix, Arizona, United States
    Recruiting
  • Kaiser Permanente-Anaheim
    Anaheim, California, United States
    Recruiting
  • AIS Cancer Center at San Joaquin Community Hospital
    Bakersfield, California, United States
    Recruiting
  • Kaiser Permanente-Bellflower
    Bellflower, California, United States
    Recruiting
  • City of Hope Comprehensive Cancer Center
    Duarte, California, United States
    Recruiting
  • Kaiser Permanente Dublin
    Dublin, California, United States
    Recruiting
Show 44 more locations
  • Kaiser Permanente-Fremont
    Fremont, California, United States
    Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Fresno, California, United States
    Recruiting
  • Kaiser Permanente-Fresno
    Fresno, California, United States
    Recruiting
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
    Irvine, California, United States
    Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, United States
    Recruiting
  • Kaiser Permanente- Modesto MOB II
    Modesto, California, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California, United States
    Recruiting
  • Kaiser Permanente-Ontario
    Ontario, California, United States
    Recruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, United States
    Recruiting
  • Kaiser Permanente-Roseville
    Roseville, California, United States
    Recruiting
  • Kaiser Permanente Downtown Commons
    Sacramento, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-South Sacramento
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-San Francisco
    San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, United States
    Recruiting
  • Kaiser Permanente San Leandro
    San Leandro, California, United States
    Recruiting
  • Kaiser San Rafael-Gallinas
    San Rafael, California, United States
    Recruiting
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, United States
    Recruiting
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, United States
    Recruiting
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Vallejo
    Vallejo, California, United States
    Recruiting
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, United States
    Recruiting
  • John Muir Medical Center-Walnut Creek
    Walnut Creek, California, United States
    Recruiting
  • Poudre Valley Hospital
    Fort Collins, Colorado, United States
    Recruiting
  • Cancer Care and Hematology-Fort Collins
    Fort Collins, Colorado, United States
    Recruiting
  • UCHealth Greeley Hospital
    Greeley, Colorado, United States
    Recruiting
  • Medical Center of the Rockies
    Loveland, Colorado, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center-Trumbull
    Trumbull, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center - Waterford
    Waterford, Connecticut, United States
    Recruiting
  • Helen F Graham Cancer Center
    Newark, Delaware, United States
    Recruiting
  • Medical Oncology Hematology Consultants PA
    Newark, Delaware, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Coral Gables
    Coral Gables, Florida, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Coral Springs
    Coral Springs, Florida, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    Deerfield Beach, Florida, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Doral
    Doral, Florida, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Hollywood
    Hollywood, Florida, United States
    Recruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Kendall
    Miami, Florida, United States
    Recruiting
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
    North Miami, Florida, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Plantation
    Plantation, Florida, United States
    Recruiting
  • Tampa General Hospital
    Tampa, Florida, United States
    Recruiting
  • Augusta University Medical Center
    Augusta, Georgia, United States
    Recruiting
  • OSF Saint Joseph Medical Center
    Bloomington, Illinois, United States
    Recruiting

+127 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.