Clinical trialNCT07215910RecruitingPhase 3Interventional

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

SponsorAlliance for Clinical Trials in OncologyEnrollment408Astrocytoma, IDH-Mutant, Grade 3

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Patrick Y Wen, MD
Alliance for Clinical Trials in Oncology
Study ChairKOL profile →
clinicaltrials.gov ↗
Rifaquat M. Rahman, MD
Alliance for Clinical Trials in Oncology
Study Chair
clinicaltrials.gov ↗
Ugonma N Chukwueke, MD
Alliance for Clinical Trials in Oncology
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

152 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Ais Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Luis Mariscal
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Keng Lam
Recruiting
Kaiser Permanente Dublin
Dublin, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-Fremont
Fremont, California, United States
Donna Molaie
Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-Fresno
Fresno, California, United States
Donna Molaie
Recruiting
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Xiao-Tang Kong
Recruiting
Kaiser Permanente- Modesto Mob Ii
Modesto, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-Oakland
Oakland, California, United States
Donna Molaie
Recruiting
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Xiao-Tang Kong
Recruiting
Kaiser Permanente-Roseville
Roseville, California, United States
Donna Molaie
Recruiting
Kaiser Permanente Downtown Commons
Sacramento, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Donna Molaie
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Orwa Aboud
Recruiting
Kaiser Permanente-San Francisco
San Francisco, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Donna Molaie
Recruiting
Kaiser Permanente San Leandro
San Leandro, California, United States
Donna Molaie
Recruiting
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Donna Molaie
Recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Donna Molaie
Recruiting
Kaiser Permanente-Vallejo
Vallejo, California, United States
Donna Molaie
Recruiting
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Gigi Q. Chen
Recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Donna Molaie
Recruiting
Yale University
New Haven, Connecticut, United States
Daniela R. Galluzzo
Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Daniela R. Galluzzo
Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Daniela R. Galluzzo
Recruiting
Helen F Graham Cancer Center
Newark, Delaware, United States
Gregory A. Masters
Recruiting
Medical Oncology Hematology Consultants Pa
Newark, Delaware, United States
Gregory A. Masters
Recruiting
Um Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Macarena I. De La Fuente
Recruiting
Um Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States
Macarena I. De La Fuente
Recruiting
Um Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Macarena I. De La Fuente
Recruiting
Um Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States
Macarena I. De La Fuente
Recruiting
Um Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States
Macarena I. De La Fuente
Recruiting
Um Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
Macarena I. De La Fuente
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Macarena I. De La Fuente
Recruiting
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States
Macarena I. De La Fuente
Recruiting
Um Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Macarena I. De La Fuente
Recruiting
Augusta University Medical Center
Augusta, Georgia, United States
Gerald C. Wallace
Recruiting
Illinois Cancercare-Bloomington
Bloomington, Illinois, United States
Bryan A. Faller
Recruiting

112 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Placebo AdministrationTemozolomide →Vorasidenib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Jun 2026
Primary completion: 31 May 2033
Completion: 31 Jan 2040
Last update posted: 2 Oct 2026
Registered enrollment: 408
Registry id: NCT07215910

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.