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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicities (DLT)

Secondary outcome measures

Overall Response Rate

Overall Survival (OS) Rate

The percent Progression Free Survival (PFS)

+1 more

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor

286 Previous Clinical Trials

11,856,968 Total Patients Enrolled

1 Trials studying Glioblastoma

36 Patients Enrolled for Glioblastoma

Adilia HormigoLead Sponsor

NovoCure Ltd.Industry Sponsor

57 Previous Clinical Trials

4,709 Total Patients Enrolled

28 Trials studying Glioblastoma

2,731 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Tumor Treating Fields for therapeutic usage?

"The safety of Tumor Treating Fields is estimated to be a 1 on our scale, as this is just an initial Phase 1 trial with limited information demonstrating its efficacy and security."

Answered by AI

Is enrollment for this trial still open to the public?

"As indicated on clinicaltrials.gov, this research program does not require participants at present. Originally listed online on March 1st 2018 and last updated July 19th 2022, it is one of 442 other studies currently recruiting patients for their respective trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

Adilia Hormigo 2018. "Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03223103.

All > Recurrent Glioblastoma > Glioblastoma Multiforme