Actively Recruiting
ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
Led by Katy Peters, MD, PhD · Updated on 2025-07-18
48
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
K
Katy Peters, MD, PhD
Lead Sponsor
S
Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.
CONDITIONS
Official Title
ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Expression of IDH1R132H in primary tumor
- Clinical or radiographic evidence of progressive Grade 2-3 glioma with more than 2 cm of non-enhancing disease in one plane
- Only first recurrence of glioma
- Signed informed consent provided
- Negative pregnancy test for females of childbearing potential at screening
- Agreement to use contraception for women of childbearing potential and male participants
- Karnofsky Performance Status (KPS) score of 70 or higher
- Expected survival of at least 12 months
- Recovery from any significant toxicities related to prior glioma surgery unless stabilized with medical management
- Adequate blood counts within 2 weeks before enrollment: ANC ≥ 1000 cells/mm3, platelet count ≥ 100,000 cells/mm3, hemoglobin ≥ 10 g/dl (transfusion allowed)
- Adequate kidney function within 2 weeks before enrollment: BUN ≤ 25 mg/dl, creatinine ≤ 1.7 mg/dl
- Adequate liver function within 2 weeks before enrollment: bilirubin ≤ 2.0 mg/dl, ALT and AST ≤ 3 times the normal range
You will not qualify if you...
- History of invasive cancer (except certain skin cancers) unless disease-free for 3 or more years
- Presence of metastases below the tentorium or outside the brain
- More than 1 cm by 1 cm of enhancing disease on MRI with contrast
- Severe active illnesses such as unstable angina, heart failure needing hospitalization, recent heart attack (within 6 months), or AIDS
- Major medical or psychiatric conditions that would prevent completing the study treatment
- Pregnant or breastfeeding women
- QTcF interval ≥ 450 msec or other risk factors for heart rhythm problems
- Active hepatitis B or C infection (controlled or immune patients allowed)
- Active gastrointestinal diseases or conditions that impair oral drug absorption (except treated reflux disease)
- Use of medications that are narrow therapeutic index CYP3A or CYP2C9 substrates
- Participation in other therapeutic clinical trials within 30 days before or during this study
- Known allergies to GM-CSF, yeast products, Leukine®, tetanus vaccine, or vorasidenib
- Prior treatment with mutant IDH1 targeted therapy
- Inability to undergo MRI imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
K
Katherine Peters, MD, PhD
CONTACT
S
Stevie Threatt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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