About this trial
This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \[BICR\] per modified Response Assessment in Neuro-Oncology \[RANO\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.
Eligibility criteria
Qualifiers
Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria
IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).
Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).
Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.
Disqualifiers
Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.
Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression
Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.
Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.
Trial design
Treatments tested in this trial
- Safusidenib