Phase 3 Study of Vorasidenib and Temozolomide After Radiation for Newly Diagnosed Grade 3 IDH-Mutant Astrocytoma

What this Trial Is About

This trial studies patients with newly diagnosed grade 3 astrocytoma that have mutations in the IDH1 or IDH2 genes. It evaluates whether adding the enzyme inhibitor vorasidenib to the usual chemotherapy drug temozolomide after radiation can improve outcomes compared to temozolomide with a placebo. This phase III study focuses on progression-free survival and other measures of treatment effectiveness and safety in these patients. Participants receive radiation therapy using advanced techniques such as intensity-modulated radiation therapy, volume modulated arc therapy, pencil beam scanning, or intensity-modulated proton therapy once daily Monday through Friday for 33 sessions. Starting four weeks after radiation, patients are randomly assigned to receive temozolomide with either vorasidenib or placebo taken orally in 28-day cycles, with temozolomide given on days 1-5 and the study drug or placebo on days 1-28, for up to 12 months. Blood samples and MRI scans are collected throughout the treatment period. After completing study treatment, participants will be followed regularly for up to 10 years to monitor progression-free survival and overall survival. Follow-ups occur every three months for the first two years, every four months for the next two years, and then every six months thereafter. Researchers also assess response rates, safety, quality of life, seizure control, and other health outcomes during treatment and follow-up to better understand the impact of vorasidenib combined with temozolomide.

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