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).
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
ViCToRy: A Phase 1b Study with Safety Lead-in of Vorasidenib in Combination with Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
Principal Investigator
Katherine
Peters
Protocol Number
PRO00108636
NCT ID
NCT05609994
Phase
I
Enrollment Status
Open to Enrollment