New brain tumor drug combo enters final testing phase
NCT ID NCT07215910
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 5 times
Summary
This Phase III trial is testing whether adding the targeted drug vorasidenib to standard chemotherapy (temozolomide) after radiation helps people with a specific type of brain tumor (IDH-mutated grade 3 astrocytoma). About 408 participants will receive either vorasidenib or a placebo alongside temozolomide. The main goal is to see if the combination delays tumor growth better than standard treatment alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vorasidenib and temozolomide
- What this could lead to
- If it works, this could lead to a new standard treatment that delays tumor growth in people with IDH-mutated grade 3 astrocytoma.
- What could go wrong
- This is an early-stage Phase III trial, so results are not yet known. Adding vorasidenib may cause additional side effects and may not improve outcomes over standard therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 408 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jan 2040
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: \-
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Astrocytoma, IDH-mutant, grade 3 are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
121 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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AIS Cancer Center at San Joaquin Community Hospital
RECRUITINGBakersfield, California, 93301, United States
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Allegheny General Hospital
RECRUITINGPittsburgh, Pennsylvania, 15212, United States
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Broadlawns Medical Center
RECRUITINGDes Moines, Iowa, 50314, United States
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Children's Hospital New Orleans
RECRUITINGNew Orleans, Louisiana, 70118, United States
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Christiana Care Health System-Concord Health Center
RECRUITINGChadds Ford, Pennsylvania, 19317, United States
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City of Hope Comprehensive Cancer Center
RECRUITINGDuarte, California, 91010, United States
Contact Email: •••••@•••••
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Coborn Cancer Center at Saint Cloud Hospital
RECRUITINGSaint Cloud, Minnesota, 56303, United States
Contact Email: •••••@•••••
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Drexel Town Square Health Center
RECRUITINGOak Creek, Wisconsin, 53154, United States
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East Jefferson General Hospital
RECRUITINGMetairie, Louisiana, 70006, United States
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Fairview Southdale Hospital
RECRUITINGEdina, Minnesota, 55435, United States
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Forbes Hospital
RECRUITINGMonroeville, Pennsylvania, 15146, United States
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Froedtert Menomonee Falls Hospital
RECRUITINGMenomonee Falls, Wisconsin, 53051, United States
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Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITINGWest Bend, Wisconsin, 53095, United States
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Froedtert and MCW Moorland Reserve Health Center
RECRUITINGNew Berlin, Wisconsin, 53151, United States
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Hackensack University Medical Center
RECRUITINGHackensack, New Jersey, 07601, United States
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Helen F Graham Cancer Center
RECRUITINGNewark, Delaware, 19713, United States
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Illinois CancerCare - Washington
RECRUITINGWashington, Illinois, 61571, United States
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Illinois CancerCare-Bloomington
RECRUITINGBloomington, Illinois, 61704, United States
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Illinois CancerCare-Canton
RECRUITINGCanton, Illinois, 61520, United States
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Illinois CancerCare-Carthage
RECRUITINGCarthage, Illinois, 62321, United States
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Illinois CancerCare-Eureka
RECRUITINGEureka, Illinois, 61530, United States
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Illinois CancerCare-Galesburg
RECRUITINGGalesburg, Illinois, 61401, United States
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Illinois CancerCare-Kewanee Clinic
RECRUITINGKewanee, Illinois, 61443, United States
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Illinois CancerCare-Macomb
RECRUITINGMacomb, Illinois, 61455, United States
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Illinois CancerCare-Ottawa Clinic
RECRUITINGOttawa, Illinois, 61350, United States
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Illinois CancerCare-Pekin
RECRUITINGPekin, Illinois, 61554, United States
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Illinois CancerCare-Peoria
RECRUITINGPeoria, Illinois, 61615, United States
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Illinois CancerCare-Peru
RECRUITINGPeru, Illinois, 61354, United States
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Illinois CancerCare-Princeton
RECRUITINGPrinceton, Illinois, 61356, United States
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Iowa Methodist Medical Center
RECRUITINGDes Moines, Iowa, 50309, United States
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITINGNew York, New York, 10016, United States
Contact Email: •••••@•••••
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MaineHealth Cancer Care Center of York County
RECRUITINGSanford, Maine, 04073, United States
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MaineHealth Coastal Cancer Treatment Center
RECRUITINGBath, Maine, 04530, United States
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MaineHealth Maine Medical Center - Portland
RECRUITINGPortland, Maine, 04102, United States
Contact Email: •••••@•••••
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MaineHealth Maine Medical Center- Scarborough
RECRUITINGScarborough, Maine, 04074, United States
Contact Email: •••••@•••••
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Medical Oncology Hematology Consultants PA
RECRUITINGNewark, Delaware, 19713, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
RECRUITINGHarrison, New York, 10604, United States
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Mercy Hospital
RECRUITINGCoon Rapids, Minnesota, 55433, United States
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Mercy Hospital Springfield
RECRUITINGSpringfield, Missouri, 65804, United States
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Mercy Medical Center - Des Moines
RECRUITINGDes Moines, Iowa, 50314, United States
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Midwestern Regional Medical Center
RECRUITINGZion, Illinois, 60099, United States
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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITINGNew York, New York, 10032, United States
Contact Email: •••••@•••••
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NYU Langone Hospital - Brooklyn
RECRUITINGBrooklyn, New York, 11220, United States
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NYU Langone Hospital - Long Island
RECRUITINGMineola, New York, 11501, United States
Contact Email: •••••@•••••
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NorthShore University HealthSystem-Evanston Hospital
RECRUITINGEvanston, Illinois, 60201, United States
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NorthShore University HealthSystem-Glenbrook Hospital
RECRUITINGGlenview, Illinois, 60026, United States
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NorthShore University HealthSystem-Highland Park Hospital
RECRUITINGHighland Park, Illinois, 60035, United States
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Northern Westchester Hospital
RECRUITINGMount Kisco, New York, 10549, United States
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Northwell Health Imbert Cancer Center
RECRUITINGBay Shore, New York, 11706, United States
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Northwell Health/Center for Advanced Medicine
RECRUITINGLake Success, New York, 11042, United States
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OSF Saint Francis Medical Center
RECRUITINGPeoria, Illinois, 61637, United States
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OSF Saint Francis Radiation Oncology at Peoria Cancer Center
RECRUITINGPeoria, Illinois, 61615, United States
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OSF Saint Joseph Medical Center
RECRUITINGBloomington, Illinois, 61701, United States
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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ProHealth D N Greenwald Center
SUSPENDEDMukwonago, Wisconsin, 53149, United States
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ProHealth Oconomowoc Memorial Hospital
SUSPENDEDOconomowoc, Wisconsin, 53066, United States
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Providence Portland Medical Center
RECRUITINGPortland, Oregon, 97213, United States
Contact Email: •••••@•••••
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Providence Saint Vincent Medical Center
RECRUITINGPortland, Oregon, 97225, United States
Contact Email: •••••@•••••
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Regions Hospital
RECRUITINGSaint Paul, Minnesota, 55101, United States
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Smilow Cancer Hospital Care Center - Waterford
RECRUITINGWaterford, Connecticut, 06385, United States
Contact Email: •••••@•••••
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Smilow Cancer Hospital Care Center-Trumbull
RECRUITINGTrumbull, Connecticut, 06611, United States
Contact Email: •••••@•••••
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Stony Brook University Medical Center
RECRUITINGStony Brook, New York, 11794, United States
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Swedish Medical Center-First Hill
RECRUITINGSeattle, Washington, 98122, United States
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The James Graham Brown Cancer Center at University of Louisville
RECRUITINGLouisville, Kentucky, 40202, United States
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Thomas Jefferson University Hospital
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
Contact Email: •••••@•••••
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Trinity Health Grand Rapids Hospital
SUSPENDEDGrand Rapids, Michigan, 49503, United States
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Tufts Medical Center
RECRUITINGBoston, Massachusetts, 02111, United States
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UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITINGIrvine, California, 92612, United States
Contact Email: •••••@•••••
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UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITINGAnkeny, Iowa, 50023, United States
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UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITINGDes Moines, Iowa, 50309, United States
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UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITINGDes Moines, Iowa, 50314, United States
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UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITINGWaukee, Iowa, 50263, United States
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITINGClive, Iowa, 50325, United States
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UI Healthcare Mission Cancer and Blood - Pella
RECRUITINGPella, Iowa, 50219, United States
Contact Email: •••••@•••••
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UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITINGCoral Gables, Florida, 33146, United States
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UM Sylvester Comprehensive Cancer Center at Coral Springs
RECRUITINGCoral Springs, Florida, 33065, United States
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UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITINGDeerfield Beach, Florida, 33442, United States
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UM Sylvester Comprehensive Cancer Center at Doral
RECRUITINGDoral, Florida, 33166, United States
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UM Sylvester Comprehensive Cancer Center at Hollywood
RECRUITINGHollywood, Florida, 33021, United States
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UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITINGMiami, Florida, 33176, United States
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UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITINGPlantation, Florida, 33324, United States
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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UPMC Hillman Cancer Center Erie
RECRUITINGErie, Pennsylvania, 16505, United States
Contact Email: •••••@•••••
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UPMC-Shadyside Hospital
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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UW Cancer Center at ProHealth Care
SUSPENDEDWaukesha, Wisconsin, 53188, United States
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United Hospital
RECRUITINGSaint Paul, Minnesota, 55102, United States
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University Medical Center New Orleans
RECRUITINGNew Orleans, Louisiana, 70112, United States
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University of California Davis Comprehensive Cancer Center
RECRUITINGSacramento, California, 95817, United States
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University of Cincinnati Cancer Center-UC Medical Center
RECRUITINGCincinnati, Ohio, 45219, United States
Contact Email: •••••@•••••
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University of Cincinnati Cancer Center-West Chester
RECRUITINGWest Chester, Ohio, 45069, United States
Contact Email: •••••@•••••
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University of Illinois
RECRUITINGChicago, Illinois, 60612, United States
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University of Kansas Cancer Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kansas Cancer Center - Briarcliff
RECRUITINGKansas City, Missouri, 64116, United States
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University of Kansas Cancer Center - Lee's Summit
RECRUITINGLee's Summit, Missouri, 64064, United States
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University of Kansas Cancer Center - North
RECRUITINGKansas City, Missouri, 64154, United States
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University of Kansas Cancer Center-Overland Park
RECRUITINGOverland Park, Kansas, 66210, United States
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University of Kansas Hospital-Indian Creek Campus
RECRUITINGOverland Park, Kansas, 66211, United States
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University of Kansas Hospital-Westwood Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
RECRUITINGNorth Miami, Florida, 33181, United States
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University of Michigan - Brighton Center for Specialty Care
RECRUITINGBrighton, Michigan, 48116, United States
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University of Michigan Health - West
RECRUITINGWyoming, Michigan, 49519, United States
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University of Michigan Rogel Cancer Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
Contact Email: •••••@•••••
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Vermont Medical Center
RECRUITINGBurlington, Vermont, 05401, United States
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University of Vermont and State Agricultural College
RECRUITINGBurlington, Vermont, 05405, United States
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UofL Health Medical Center Northeast
RECRUITINGLouisville, Kentucky, 40245, United States
Contact Email: •••••@•••••
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West Jefferson Medical Center
RECRUITINGMarrero, Louisiana, 70072, United States
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Wexford Health and Wellness Pavilion
RECRUITINGWexford, Pennsylvania, 15090, United States
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
Contact Email: •••••@•••••
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