13 Participants Needed

Personalized Vaccine + TTFields for Glioblastoma

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Albert Einstein College of Medicine
Must be taking: Temozolomide, Dexamethasone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).The study is designed to determine whether this treatment combination is well tolerated and safe.

Research Team

AH

Adilia Hormigo, MD, PhD

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

My diagnosis is Grade IV brain cancer (GBM).
I am undergoing surgery to remove as much of the tumor as possible, followed by radiation therapy with Temozolomide.
My condition hasn't worsened after chemotherapy and radiation.
See 9 more

Exclusion Criteria

I have HIV/AIDS or chronic hepatitis B/C.
My condition has worsened recently.
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Chemotherapy

Participants undergo radiation and chemotherapy as part of the standard care treatment for glioblastoma

6-8 weeks

Treatment

Participants receive the MTA-based personalized vaccine in conjunction with Tumor Treating Fields during the maintenance phase of temozolomide

42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Long-term Follow-up

Participants are assessed for overall response rate using RANO criteria

2 years

Treatment Details

Interventions

  • MTA-based vaccine
  • Poly-ICLC
  • Tumor Treating Fields
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Mutation-derived tumor vaccineExperimental Treatment3 Interventions
MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials
302
Recruited
11,690,000+

Adilia Hormigo

Lead Sponsor

Trials
1
Recruited
10+

NovoCure Ltd.

Industry Sponsor

Trials
64
Recruited
6,100+

Ashley Cordova

NovoCure Ltd.

Chief Executive Officer

Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel

Uri Weinberg

NovoCure Ltd.

Chief Medical Officer since 2020

MD from an unspecified institution

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