Your session is about to expire
← Back to Search
Cancer Vaccine
Personalized DNA Vaccine + PD-1 Blockade for Glioblastoma
Phase 1
Recruiting
Led By Tanner M Johanns, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through progression (up to 36 months)
Awards & highlights
Study Summary
This trial will test a personalized neoantigen-based DNA vaccine, combined with PD-1 blockade, to maximize tumor-specific response and minimize toxicity in people newly diagnosed with glioblastoma.
Who is the study for?
This trial is for adults with newly diagnosed, unmethylated glioblastoma who haven't had prior immunotherapy. Participants must have adequate organ function, agree to use contraception, and can consent to genome sequencing. They should not have certain other cancers within the last 3 years or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests a personalized neoantigen DNA vaccine combined with Retifanlimab PD-1 blockade therapy in patients with glioblastoma. It aims to enhance T cell responses against cancer while keeping side effects low and will set the stage for future efficacy studies.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to PD-1 blockade (like inflammation of organs), reactions at injection sites from the vaccine or electroporation device, fatigue, blood disorders, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through progression (up to 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through progression (up to 36 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety as measured by treatment-related dose-limiting toxicity (DLT) rate related to vaccination
Secondary outcome measures
Immunogenicity as measured by T cell receptor (TCR) sequencing to assess diversity of clonality and putative antigen specificity
Immunogenicity as measured by T-cell phenotype, myeloid derived suppressor cell frequency (MDSC) assessed by flow cytometry
Immunogenicity as measured by pro- and anti-inflammatory chemokine analysis and cytokine analysis in plasma as assessed by multiplex ELISA
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: Personalized neoantigen DNA vaccine + retifanlimabExperimental Treatment3 Interventions
Cohort B will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection plus concurrent retifanlimab beginning with Dose 1 and continuing for a total of 6 doses.
The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days.
Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab
Group II: Cohort A: Personalized neoantigen DNA vaccine + retifanlimabExperimental Treatment3 Interventions
Cohort A will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection alone during the first two priming doses, then concurrently with retifanlimab during the subsequent boosting doses (Doses 3 through 6)
The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days.
Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
2018
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
Ichor Medical Systems IncorporatedIndustry Sponsor
10 Previous Clinical Trials
427 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,683 Total Patients Enrolled
17 Trials studying Glioblastoma
609 Patients Enrolled for Glioblastoma
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,283 Total Patients Enrolled
5 Trials studying Glioblastoma
530 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never received immunotherapy.I haven't had cancer in the past 3 years, except for certain types that were fully treated.I have not had a live vaccine in the last 4 weeks.My biopsy did not collect enough tissue for specific cancer tests.My screening did not identify any specific cancer markers.I do not have any uncontrolled neurological conditions like seizures.I have or had lung scarring or inflammation not caused by an infection.I have an immune system disorder and am on medication to suppress my immune system.I have a bleeding or clotting disorder that prevents me from getting shots in my muscles.I do not have severe brain pressure, uncontrolled seizures, or need immediate brain treatment.I am currently being treated for active hepatitis B or C.I agree to have my genes sequenced and shared for research.I am 18 years old or older.I do not have any unmanaged ongoing illnesses.I have had brain surgery for a tumor, including biopsy or removal.I have had an organ or stem cell transplant.My skin is thicker than 50 mm at all possible injection sites.I have a pacemaker or defibrillator on the same side as my planned deltoid injection.I have had fainting spells due to sudden drops in heart rate or blood pressure.My brain tumor is a high-grade, aggressive type and not caused by IDH mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Personalized neoantigen DNA vaccine + retifanlimab
- Group 2: Cohort B: Personalized neoantigen DNA vaccine + retifanlimab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available positions in this clinical investigation for volunteers?
"According to clinicaltrials.gov, this medical study is no longer recruiting patients; the trial was first posted on June 30th 2023 before being updated for the last time in February 14th 2023. Nevertheless, there are still 446 other trials that require volunteers right now."
Answered by AI
Has the FDA accepted Cohort A: Personalized neoantigen DNA vaccine + retifanlimab for clinical use?
"Due to the limited clinical data concerning Cohort A: Personalized neoantigen DNA vaccine + retifanlimab, our team at Power gave it a safety score of 1. This is indicative of its Phase 1 status which means there are no prior studies that have established efficacy or safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger