Your session is about to expire
← Back to Search
Cancer Vaccine
Vaccine + Vorasidenib for Brain Cancer (ViCToRy Trial)
Phase 1
Waitlist Available
Led By Katherine Peters, MD, PhD
Research Sponsored by Katy Peters, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
IDH1R132H expression in primary tumor
Karnofsky Performance Status (KPS) of ≥ 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
ViCToRy Trial Summary
This trial will study a vaccine & drug combo to treat recurrent brain tumors in adults.
Who is the study for?
Adults over 18 with a first recurrence of IDH1 mutant lower grade gliomas, who have recovered from prior treatments and have good organ function. They must not be pregnant or breastfeeding, agree to use contraception, and should not have severe medical conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing the combination of PEPIDH1M vaccine and vorasidenib in patients with recurrent brain tumors (lower grade gliomas). It aims to assess how safe this combo is and how well it works against these tumors.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system due to the vaccine, liver issues because vorasidenib affects enzymes in the liver, as well as general side effects like fatigue or digestive problems.
ViCToRy Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My primary tumor tests positive for IDH1R132H.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I am 18 years old or older.
Select...
My condition has returned only once.
Select...
My brain tumor is growing and is larger than 2 cm in one direction without contrast enhancement.
Select...
I have recovered from any major side effects of surgery for brain cancer.
ViCToRy Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glioma
To assess the safety of the PEPIDH1M vaccine in combination vorasidenib in adult patients with progressive IDH1 mutant World Health Organization (WHO) Grade 2-3 gliomas
ViCToRy Trial Design
1Treatment groups
Experimental Treatment
Group I: PEPIDH1M vaccine + vorasidenibExperimental Treatment1 Intervention
Patients will receive vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids) intramuscularly into the deltoid muscle. Patients will then receive vorasidenib 40mg orally once a day for 28 days. After two cycles of 28-day vorasidenib and at the start of the 3rd cycle of vorasidenib, patients will receive the PEPIDH1M vaccine intradermally (i.d.) to alternating groin regions on the following schedule: vaccine #1, day 1; vaccine #2, day 15. The day before vaccine #1, patients will receive a vaccine site pre-conditioning injection of a single dose of Td toxoid. This will be administered twelve hours to one day prior to receiving PEPIDH1M vaccine i.d. to the RIGHT groin area. Vaccines #3 and #4 will be given on day 1 and day 15 of cycle 4. Starting on 6th cycle of 28-day vorasidenib, subjects will receive PEPIDH1M vaccine (i.d. to alternating groin regions) every 28 days on day 1 for vaccine #5-#12. Patients will receive up to a total of 14 cycles of vorasidenib.
Find a Location
Who is running the clinical trial?
ServierIndustry Sponsor
49 Previous Clinical Trials
43,408 Total Patients Enrolled
Katy Peters, MD, PhDLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Katherine Peters, MD, PhDPrincipal InvestigatorDuke University
6 Previous Clinical Trials
318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with mIDH1 targeted therapy before.My primary tumor tests positive for IDH1R132H.You are expected to live for at least 12 more months.I am 18 years old or older.My condition has returned only once.My hemoglobin level is at least 10 g/dl.I have been hospitalized for heart issues recently.I am not on medications that are sensitive to enzyme changes due to the study drug.You are allergic or hypersensitive to the tetanus vaccine or any of its ingredients.I agree to use birth control during the study.You are allergic to GM-CSF, yeast-derived products, or any ingredient in Leukine®.You are allergic to any part of vorasidenib.I have recovered from any major side effects of surgery for brain cancer.My liver is working well, as confirmed by recent tests.My kidney function is good as per recent tests.My brain tumor is growing and is larger than 2 cm in one direction without contrast enhancement.I do not have any major stomach or bowel issues that affect how I absorb medicine taken by mouth, except for treated acid reflux.I am able to care for myself but may not be able to do active work.I have hepatitis B or C, but it's under control or I'm immune.You have a serious, ongoing health condition.My cancer has spread to the lower part of my brain or beyond.I have been cancer-free for over 3 years, except for non-dangerous skin cancers.I have not had a heart attack in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: PEPIDH1M vaccine + vorasidenib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Low Grade Glioma Patient Testimony for trial: Trial Name: NCT05609994 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have the regulatory authorities granted their acceptance of PEPIDH1M vaccine + vorasidenib?
"Due to the limited data surrounding its safety and efficacy, PEPIDH1M vaccine + vorasidenib has been assessed as a 1 on our team's rating scale."
Answered by AI
Are new participants still being accepted for the trial?
"According to the information hosted on clinicaltrials.gov, this medical trial is not presently looking for candidates. It was posted in January of 2023 and last updated in November 2022; however, 356 other trials are actively recruiting at present."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
When Will this clinical trial start?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have an Astrocytoma Grade II , IDH mutated. I have recieve only surgery. Im very interested on IDH inhibitor treatment.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger