What side effects are associated with this type of intervention?

Common treatments for glioblastoma, including personalized neoantigen-based vaccines that stimulate the immune response against tumor-specific antigens, often have side effects related to immune activation. These can include flu-like symptoms, injection site reactions, and fatigue. More broadly, treatments like temozolomide, a standard chemotherapy for glioblastoma, can cause nausea, vomiting, fatigue, and myelosuppression (reduced bone marrow activity). Radiation therapy, another common treatment, may lead to hair loss, skin irritation, and cognitive changes. Immune checkpoint inhibitors, sometimes used in glioblastoma, can cause immune-related adverse events such as colitis, hepatitis, and endocrinopathies.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma that focus on stimulating the immune response. One notable approval is for the use of pembrolizumab, an anti-PD-1 monoclonal antibody, which has shown efficacy in various cancers by enhancing the body's immune response against tumor cells. Additionally, the FDA has approved bevacizumab, an anti-VEGF antibody, for recurrent Glioblastoma, which works by inhibiting angiogenesis but also has immunomodulatory effects. While not specifically a vaccine, these treatments share the common goal of leveraging the immune system to target cancer cells.

What other types of research exist?

Promising novel alternatives to personalized neoantigen-based vaccines for glioblastoma patients include: 1) Bevacizumab, an anti-VEGF antibody, which has shown efficacy in reducing tumor growth and sparing surgery in neurofibromatosis type 2-related tumors. 2) Everolimus, an mTORC1 inhibitor, which has demonstrated potential in controlling tumor growth in various studies. 3) CAR T-cell therapies targeting specific tumor antigens, which are being explored in clinical trials for their ability to harness the immune system against glioblastoma. 4) Combination therapies involving immune checkpoint inhibitors like nivolumab and ipilimumab, which have shown promise in enhancing anti-tumor immune responses.

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Cancer Vaccine

Personalized DNA Vaccine for Glioblastoma

Phase 1

Waitlist Available

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 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a custom-made vaccine designed to help the immune system attack brain cancer cells. It targets patients with a specific type of brain cancer that hasn't responded to usual treatments. The vaccine works by teaching the immune system to recognize and destroy cancer cells based on unique markers.

Who is the study for?

This trial is for adults with newly diagnosed, unmethylated glioblastoma who've had a craniotomy or resection. Participants must consent to genome sequencing and agree to use contraception. They should have normal organ function, not be on high-dose steroids, and can't have other cancers within the last 3 years or any immune system disorders.

What is being tested?

The study tests a personalized neoantigen-based DNA vaccine using the CELLECTRA®2000 EP Device in patients with glioblastoma. It aims to assess safety and how well it triggers an immune response against the cancer.

What are the potential side effects?

Potential side effects may include reactions at the injection site, allergic responses similar to those from other vaccines (like hives or difficulty breathing), and possibly effects related to IL-12 like fatigue or flu-like symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of a personalized neoantigen DNA vaccine as measured by dose-limiting toxicities (DLTs)

Secondary study objectives

Number of high quality candidates neoantigens present in patients with newly diagnosed GBM

Progression-free survival (PFS) rate

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: Vaccine (GNOS-PV01 + INO-9012)Experimental Treatment3 Interventions

* Standard radiation therapy will be administered per standard of care and is outside the scope of this study. * GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The personalized neoantigen-based vaccine for Glioblastoma works by stimulating the patient's immune system to recognize and attack tumor-specific antigens, which are unique to the cancer cells. This approach aims to enhance the body's natural defenses against the tumor. Other common treatments for Glioblastoma include surgical resection to remove as much of the tumor as possible, radiation therapy to kill remaining cancer cells, and chemotherapy to target rapidly dividing cells. These treatments are crucial for Glioblastoma patients as they address the aggressive nature of the tumor, aiming to prolong survival and improve quality of life.