Personalized Vaccine + TTFields for Glioblastoma

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Albert Einstein College of Medicine

Must be taking: Temozolomide, Dexamethasone

Must not be taking: Investigational agents

Disqualifiers: Disease progression, Implanted devices, HIV/AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 42 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new personalized vaccine (MTA-based vaccine) combined with standard treatments for glioblastoma, an aggressive brain cancer. The goal is to determine the safety and tolerability of this combination. Participants should have glioblastoma that remains stable after surgery, radiation, and chemotherapy. This study might suit individuals who have undergone surgery and radiation for glioblastoma and whose condition is stable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of Dexamethasone (4mg or less daily). If you are taking drugs that cause immune suppression, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers tested a vaccine made from specific changes in tumor cells, called the MTA-based vaccine, in patients. The study assessed the vaccine's safety and patient tolerance. Early results suggested the vaccine was generally well-tolerated, with no major safety issues reported.

Poly-ICLC, often used with vaccines, has also undergone study. Research has shown it is safe for patients, with most not experiencing serious side effects.

Tumor Treating Fields (TTFields) have been researched for treating glioblastoma, a type of brain cancer. Studies indicate that serious side effects are rare, with only 0.5% directly linked to TTFields therapy.

Overall, these treatment components—the MTA-based vaccine, poly-ICLC, and TTFields—have demonstrated safety in previous studies. This suggests they might be well-tolerated when used together in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for glioblastoma, which typically include surgery, radiation, and chemotherapy, the MTA-based personalized vaccine offers a unique approach. This vaccine targets tumor-specific mutations by using peptides combined with Poly-ICLC, which can enhance the immune system's response to cancer cells. Additionally, it's used alongside Tumor Treating Fields (TTFields), a novel method that uses electric fields to disrupt cancer cell division. Researchers are excited because this combination has the potential to not only attack the tumor more precisely but also to improve outcomes with fewer side effects.

What evidence suggests that this trial's treatments could be effective for glioblastoma?

Research has shown that peptide vaccines, such as the MTA-based vaccine, yield promising results in treating glioblastoma, a type of brain cancer. In previous studies, patients who received these vaccines had a 3-year survival rate of 84% and a 63% rate of living without cancer progression. In this trial, participants will receive the MTA-based Personalized Vaccine, which includes Poly-ICLC, known for its success in aiding the immune system to combat glioblastoma. Additionally, Tumor Treating Fields (TTFields) will be used, which have effectively extended patient survival, with an average survival time of 21.3 months and 12.6 months without cancer progression when combined with standard treatments. These treatments work together in this trial to improve patient outcomes by attacking the tumor in different ways. ^{1 3 4 6 7}

Who Is on the Research Team?

Adilia Hormigo, MD, PhD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Mutation-derived tumor vaccine Experimental Treatment 3 Interventions

MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12166567/

Recent developments in peptide vaccines against ... The vaccine had an OS rate of 84% and a PFS rate of 63% after three years, with an 82% two-year PFS rate in patients who experienced immune ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03223103

Study Details | NCT03223103 | Safety and Immunogenicity ... This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12418593/

Translational advancements in tumor vaccine therapies for ... This review provides an overview of recent advancements and notable clinical trials in tumor vaccine development for GBM. Additionally, it ...

4. academic.oup.com academic.oup.com/noa/article/7/1/vdaf135/8171342

Advancing vaccine-based immunotherapy in glioblastoma ... These vaccines are intended to activate the immune system to recognize and fight tumor cells.158 The following is a comparison of various GBM ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14397-1

Efficacy of vaccination therapy in newly diagnosed and ... Vaccination therapy showed potential survival benefits for GB patients; however, further phase III studies are needed to validate these results.

6. trials.braintumor.org trials.braintumor.org/trials/NCT03223103

Safety and Immunogenicity of Personalized Genomic Vaccine ... 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 ...

7. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03223103/

Clinical Trial: NCT03223103 This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients ...