ViCToRy: Vorasidenib + Peptide Vaccine for rLGGs (Lower Grade Glioma) - Clinical Trial

¿Cuál es el Propósito de este estudio?

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).

¿Cuál es la Condición que se está estudiando?

Recurrent or Progressive Lower Grade Glioma (WHO grades 2-3) with IDH1 Mutations

¿Quién puede participar en el Estudio?

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.

Grupo etario
Adultos

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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
Investigador Principal
Katherine B. Peters, MD, PhD
Especialista en neuro-oncología
Número de Protocolo
IRB: PRO00108636
NCT: NCT05609994
Fase
Fase I
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
Participate
Apoye la investigación de Duke Health o rinda homenaje a un ser querido con un regalo conmemorativo.
Contribuya a Duke Health