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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT07215910

Registry updated: 2026-10-02
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Description

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.

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

Eligibility 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: \-

Conditions

Astrocytoma, IDH-Mutant, Grade 3

Locations

  • AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
  • City of Hope Comprehensive Cancer Center — Duarte, California, United States
  • Kaiser Permanente Dublin — Dublin, California, United States
  • Kaiser Permanente-Fremont — Fremont, California, United States
  • Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States
  • Kaiser Permanente-Fresno — Fresno, California, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • Kaiser Permanente- Modesto MOB II — Modesto, California, United States
  • Kaiser Permanente-Oakland — Oakland, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
  • Kaiser Permanente-Roseville — Roseville, California, United States
  • Kaiser Permanente Downtown Commons — Sacramento, California, United States
  • University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
  • Kaiser Permanente-South Sacramento — Sacramento, California, United States
  • Kaiser Permanente-San Francisco — San Francisco, California, United States
  • Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States
  • Kaiser Permanente San Leandro — San Leandro, California, United States
  • Kaiser San Rafael-Gallinas — San Rafael, California, United States
  • Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
  • Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States
  • Kaiser Permanente-South San Francisco — South San Francisco, California, United States
  • Kaiser Permanente-Vallejo — Vallejo, California, United States
  • Kaiser Permanente-Walnut Creek — Walnut Creek, California, United States
  • John Muir Medical Center-Walnut Creek — Walnut Creek, California, United States
  • Yale University — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
  • Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States
  • Helen F Graham Cancer Center — Newark, Delaware, United States
  • Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Springs — Coral Springs, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Hollywood — Hollywood, Florida, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
  • Augusta University Medical Center — Augusta, Georgia, United States
  • OSF Saint Joseph Medical Center — Bloomington, Illinois, United States
  • Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
  • Illinois CancerCare-Canton — Canton, Illinois, United States
  • Illinois CancerCare-Carthage — Carthage, Illinois, United States
  • University of Illinois — Chicago, Illinois, United States
  • Illinois CancerCare-Eureka — Eureka, Illinois, United States
  • NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
  • Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
  • NorthShore University HealthSystem-Glenbrook Hospital — Glenview, Illinois, United States
  • NorthShore University HealthSystem-Highland Park Hospital — Highland Park, Illinois, United States
  • Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
  • Illinois CancerCare-Macomb — Macomb, Illinois, United States
  • Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
  • Illinois CancerCare-Pekin — Pekin, Illinois, United States
  • Illinois CancerCare-Peoria — Peoria, Illinois, United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center — Peoria, Illinois, United States
  • OSF Saint Francis Medical Center — Peoria, Illinois, United States
  • Illinois CancerCare-Peru — Peru, Illinois, United States
  • Illinois CancerCare-Princeton — Princeton, Illinois, United States
  • Illinois CancerCare - Washington — Washington, Illinois, United States
  • Midwestern Regional Medical Center — Zion, Illinois, United States
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
  • Iowa Methodist Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
  • Broadlawns Medical Center — Des Moines, Iowa, United States
  • Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
  • UI Healthcare Mission Cancer and Blood - Pella — Pella, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • Lawrence Memorial Hospital — Lawrence, Kansas, United States
  • University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
  • University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
  • UofL Health Medical Center Northeast — Louisville, Kentucky, United States
  • West Jefferson Medical Center — Marrero, Louisiana, United States
  • East Jefferson General Hospital — Metairie, Louisiana, United States
  • University Medical Center New Orleans — New Orleans, Louisiana, United States
  • Children's Hospital New Orleans — New Orleans, Louisiana, United States
  • MaineHealth Coastal Cancer Treatment Center — Bath, Maine, United States
  • MaineHealth Maine Medical Center - Portland — Portland, Maine, United States
  • MaineHealth Cancer Care Center of York County — Sanford, Maine, United States
  • MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States
  • Tufts Medical Center — Boston, Massachusetts, United States
  • Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
  • University of Michigan - Brighton Center for Specialty Care — Brighton, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
  • Trinity Health Grand Rapids Hospital — Grand Rapids, Michigan, United States
  • University of Michigan Health - West — Wyoming, Michigan, United States
  • Mercy Hospital — Coon Rapids, Minnesota, United States
  • Fairview Southdale Hospital — Edina, Minnesota, United States
  • Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
  • Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
  • Regions Hospital — Saint Paul, Minnesota, United States
  • United Hospital — Saint Paul, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • University of Kansas Cancer Center - Briarcliff — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - North — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
  • Mercy Hospital Springfield — Springfield, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Northwell Health Imbert Cancer Center — Bay Shore, New York, United States
  • NYU Langone Hospital - Brooklyn — Brooklyn, New York, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — Harrison, New York, United States
  • Northwell Health/Center for Advanced Medicine — Lake Success, New York, United States
  • NYU Langone Hospital - Long Island — Mineola, New York, United States
  • Northern Westchester Hospital — Mount Kisco, New York, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • University of Cincinnati Cancer Center-West Chester — West Chester, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Providence Portland Medical Center — Portland, Oregon, United States
  • Providence Saint Vincent Medical Center — Portland, Oregon, United States
  • Christiana Care Health System-Concord Health Center — Chadds Ford, Pennsylvania, United States
  • UPMC Hillman Cancer Center Erie — Erie, Pennsylvania, United States
  • Forbes Hospital — Monroeville, Pennsylvania, United States
  • Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
  • Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC-Shadyside Hospital — Pittsburgh, Pennsylvania, United States
  • Wexford Health and Wellness Pavilion — Wexford, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • University of Vermont and State Agricultural College — Burlington, Vermont, United States
  • Swedish Medical Center-First Hill — Seattle, Washington, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • ProHealth D N Greenwald Center — Mukwonago, Wisconsin, United States
  • Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • ProHealth Oconomowoc Memorial Hospital — Oconomowoc, Wisconsin, United States
  • UW Cancer Center at ProHealth Care — Waukesha, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record