About this trial
This trial is looking at how adding a drug called vorasidenib to the usual treatment of temozolomide can help patients with newly diagnosed grade 3 astrocytoma. The goal is to see if this combination works better than temozolomide alone after radiation therapy. Temozolomide is a medicine that can damage cancer cells and slow their growth. Vorasidenib targets specific changes in cancer cells to help stop their growth.
The trial ID is NCT07215910. It is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. The study is not FDA regulated. The trial hopes to include about 408 participants.
Who can join
People aged 12 and older can join this study. It is open to both men and women. To be eligible, participants must have a confirmed diagnosis of grade 3 astrocytoma with specific gene changes. They should not have had certain prior treatments or other serious health issues. The trial team will check who can join based on these criteria.
Condition
Astrocytoma, IDH-Mutant, Grade 3
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. One group will receive temozolomide and a placebo, while the other group will receive temozolomide and vorasidenib. Everyone will also get radiation therapy. Treatments will continue for up to 12 months. Throughout the study, blood samples will be taken and MRIs will be performed to monitor progress.
Where
This trial is running at 82 locations in the United States. All of them are currently recruiting.
Allegheny General Hospital
Pittsburgh, Pennsylvania
Broadlawns Medical Center
Des Moines, Iowa
Children's Hospital New Orleans
New Orleans, Louisiana
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania
City of Hope Comprehensive Cancer Center
Duarte, California
Drexel Town Square Health Center
Oak Creek, Wisconsin
East Jefferson General Hospital
Metairie, Louisiana
Forbes Hospital
Monroeville, Pennsylvania
The first 8 of 82 sites are listed here. The registry record has the full list.