Studying a New Investigational Drug in the Fight Against Low-Grade Glioma
The INDIGO Study is a Phase 3 clinical trial evaluating the safety and effectiveness of vorasidenib in people with Grade 2 low-grade gliomas with an IDH mutation. If you are interested in participating, this site can provide information and guidance to help you discuss next steps with your doctor.
The INDIGO Study and low-grade glioma
If your doctor has spoken with you about low-grade glioma, you probably know the available options for treatment are limited. Your doctor may have talked about a “watch and wait” period, during which your medical team will monitor your disease on a regular basis and determine when a treatment such as chemotherapy and radiation might be needed.1
The INDIGO study is testing a new investigational drug called vorasidenib that targets IDH mutations present in the tumor. These mutations occur in about 70-80% of Grade 2 and Grade 3 gliomas, as well as secondary glioblastomas.2 This study will investigate vorasidenib in people with Grade 2 glioma with an IDH mutation who are currently being managed in a watch and wait period.
The effectiveness and safety of vorasidenib have not been established. There is no guarantee that vorasidenib will receive health authority approval or become commercially available in any country for the use being investigated.
Weller M, van den Bent M, Tonn JC, et al. European Association for NeuroOncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas. Lancet Oncol. 2017;18(6):e315-e329.
Yan H, Parsons DW, Jin G, et al. IDH1 and IDH2 Mutations in Gliomas. N Engl J Med. 2009; 360(8):765-773.
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