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Cancer Vaccine

Personalized Vaccine + TTFields for Glioblastoma

Phase 1
Waitlist Available
Led By Adilia Hormigo, MD, PhD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18
Confirmation of GBM (WHO grade IV)
Must not have
(HIV/AIDS), Chronic hepatitis B or hepatitis C
Progression of disease at time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a vaccine, based on a patient's unique tumor mutations, in combination with standard care and a new cancer treatment called TTFields, to treat glioblastoma. The goal is to see if the combination is safe and well tolerated.

Who is the study for?
Adults over 18 with confirmed Glioblastoma (GBM) who have stable disease after radiation and chemotherapy, a life expectancy of more than 16 weeks, and good performance status. They must have completed maximal surgery, radiotherapy with Temozolomide, and be on a low dose of Dexamethasone. Participants need sufficient tumor tissue for sequencing and acceptable organ function. They should not have certain autoimmune diseases or implanted electronic devices in the brain.
What is being tested?
The trial is testing the safety of a personalized genomic vaccine combined with TTFields against GBM. The vaccine targets mutations in each patient's tumor alongside standard treatments to see if it's safe and well-tolerated.
What are the potential side effects?
Potential side effects may include reactions at the injection site from the vaccine, skin irritation from TTFields application, fatigue, flu-like symptoms due to immune activation by Poly-ICLC or Peptides, as well as possible interference with normal organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My diagnosis is Grade IV brain cancer (GBM).
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I am undergoing surgery to remove as much of the tumor as possible, followed by radiation therapy with Temozolomide.
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My bone marrow is functioning well.
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My first vaccine dose is scheduled 4-8 weeks after my last Temozolomide or radiotherapy dose.
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I can take care of myself and perform daily activities.
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I am on a stable dose of Dexamethasone, 4mg or less daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have HIV/AIDS or chronic hepatitis B/C.
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My condition has worsened recently.
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My cancer is located below the tentorium in my brain or is present in multiple areas.
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I have a condition that weakens my immune system.
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I had cancer before and was treated for it within the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-limiting toxicities (DLT)
Secondary study objectives
Overall Response Rate
Toxicity grading using CTCAE scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mutation-derived tumor vaccineExperimental Treatment3 Interventions
MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly-ICLC
2016
Completed Phase 2
~240
Peptides
2016
Completed Phase 1
~250

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
296 Previous Clinical Trials
11,688,872 Total Patients Enrolled
1 Trials studying Glioblastoma
36 Patients Enrolled for Glioblastoma
Adilia HormigoLead Sponsor
NovoCure Ltd.Industry Sponsor
62 Previous Clinical Trials
5,978 Total Patients Enrolled
29 Trials studying Glioblastoma
3,723 Patients Enrolled for Glioblastoma
Adilia Hormigo, MD, PhDPrincipal InvestigatorAlbert Einstein College of Medicine
1 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Glioblastoma
13 Patients Enrolled for Glioblastoma

Media Library

MTA-based vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03223103 — Phase 1
Glioblastoma Research Study Groups: Mutation-derived tumor vaccine
Glioblastoma Clinical Trial 2023: MTA-based vaccine Highlights & Side Effects. Trial Name: NCT03223103 — Phase 1
MTA-based vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03223103 — Phase 1
~2 spots leftby Dec 2025
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