ViCToRy: Vorasidenib + Peptide Vaccine for rLGGs (Lower Grade Glioma) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if the combination of an investigational peptide (small protein) vaccine developed at Duke and a drug called vorasidenib is a safe and effective option for people with recurrent or progressive IDH1 mutant lower grade gliomas (brain tumors).
Recurrent or Progressive Lower Grade Glioma (WHO grades 2-3) with IDH1 Mutations
Who Can Participate in the Study?
Adults ages 18+ who:
- Have IDH1 expression in their primary tumor
- Have clinical and/or radiographic, recurrent, or progressive WHO grades 2-3 glioma
- Do not have more than 1cm x 1cm of enhancing disease on gadolinium contrasted MRI
- Do not have a known hypersensitivity to GM-CSF, yeast-derived products, or any component of lkeukine
- Have not had previous therapy targeted toward IDH1 mutations
For more information, contact the study team at 919-684-5301.
What is Involved?
If you choose to join this study, you will get a tetanus and diphtheria toxoids (Td) vaccine booster injection in the muscle of your arm. You will then start the study peptide injections along with vorasidenib (an FDA approved drug), which you will take by mouth.
During the study you will have physical exams, blood draws, electrocardiograms, MRI scans, and fill out surveys about your health. You will be in this study for approximately 16 months.
Study Details
