What is the mechanism of action of this treatment?

Glioblastoma treatments often focus on targeting the cancer cells directly or enhancing the body's immune response to these cells. Traditional treatments include surgery to remove as much of the tumor as possible, followed by radiation therapy and chemotherapy with agents like temozolomide, which damages the DNA of cancer cells, leading to cell death. Immune-based therapies, such as the investigational vaccine VBI-1901, aim to activate the immune system to recognize and attack glioblastoma cells. This approach is significant for patients as it offers a potential method to target residual cancer cells that are not removed by surgery or killed by radiation and chemotherapy, potentially improving outcomes and reducing recurrence.

What side effects are associated with this type of intervention?

Common treatments for glioblastoma that involve immune system activation, such as immune checkpoint inhibitors like nivolumab and ipilimumab, often have side effects including fatigue, rash, diarrhea, and colitis. More severe immune-mediated toxicities can include hepatitis, hypophysitis, and pneumonitis. Additionally, patients may experience infusion-related reactions, fever, and headache. These side effects are generally manageable but can sometimes require discontinuation of therapy or additional treatments to mitigate the adverse effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapy treatments for glioblastoma that focus on activating the immune system against cancer cells. One notable example is pembrolizumab, an immune checkpoint inhibitor that targets the PD-1 pathway, enhancing the body's immune response to cancer cells. Another example is nivolumab, which also targets the PD-1 pathway and has shown efficacy in various cancers, including glioblastoma. These treatments are similar to the investigational vaccine VBI-1901, which aims to stimulate the immune system to recognize and attack glioblastoma cells.

What other types of research exist?

Promising novel alternatives to VBI-1901 for glioblastoma patients include: 1) Bevacizumab, an anti-VEGF antibody, which has shown efficacy in reducing tumor growth and improving symptoms. 2) Nivolumab, a PD-1 inhibitor, which has demonstrated activity in recurrent glioblastoma. 3) Dabrafenib plus trametinib, targeting BRAF V600E mutations, which has shown sustained tumor control in gliomas. 4) CAR T-cell therapies targeting specific tumor antigens, which are being actively investigated in clinical trials. Patients should discuss these options with their healthcare provider to determine the best course of action based on their specific condition.

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Cancer Vaccine

GBM Vaccine for Glioblastoma

Phase 1 & 2

Recruiting

Research Sponsored by VBI Vaccines Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status (KPS) score ≥ 70%

18-70 years of age

Must not have

History of certain cancers or immunosuppressive diseases

Intra-tumoral or peri-tumoral hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose to date of progression or death, as well as at 6, 12, 18 and 24 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new vaccine called VBI-1901 for patients whose brain cancer, glioblastoma, has returned. The vaccine aims to help the immune system recognize and fight the cancer cells. Researchers are checking if the vaccine is safe and finding the best dose to use.

Who is the study for?

This trial is for adults aged 18-70 with recurrent glioblastoma (GBM) who've had initial treatment including surgery and radiation, possibly with chemotherapy. They must have stable or decreasing corticosteroid use, recovered from prior treatments, no large or multi-focal tumors on MRI, and adequate organ function. Women of childbearing age need a negative pregnancy test and agree to contraception.

What is being tested?

The study tests the safety and tolerability of VBI-1901 vaccine in combination with standard chemotherapy drugs Carmustine or Lomustine in patients with recurrent GBM. It aims to find the optimal dose of VBI-1901 by gradually increasing it among participants while monitoring their reactions.

What are the potential side effects?

Possible side effects include typical reactions to vaccines such as soreness at injection site, fever, fatigue; plus those related to chemotherapy like nausea, hair loss, low blood cell counts leading to increased infection risk. Severity can vary based on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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I am between 18 and 70 years old.

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I take 4mg or less of corticosteroids daily.

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I have been diagnosed with a grade IV glioblastoma.

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My cancer has grown or returned after treatment, confirmed by MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer or diseases that weaken my immune system.

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I have bleeding inside or around my tumor.

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I am currently receiving IV treatment for an infection.

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I take more than 4 mg/day of corticosteroids.

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I have recently been on medication that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose to date of progression or death, as well as at 6, 12, 18 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose to date of progression or death, as well as at 6, 12, 18 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose to date of progression or death, as well as at 6, 12, 18 and 24 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Cellular immune responses

Progression free survival (PFS)

Safety and efficacy of VBI-1901 compared to standard of care (SOC) in Part C of study

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Part C VBI-1901 with GM-CSF AdjuvantExperimental Treatment1 Intervention

VBI-1901 10 μg HCMV pp65 formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal ID injections.

Group II: Part B GM-CSF AdjuvantExperimental Treatment1 Intervention

VBI-1901 10 μg HCMV pp65 formulated with GM-CSF (200 μg) in 0.2 to 0.4 mL volume, given in two to four equal ID injections.

Group III: Part B AS01B AdjuvantExperimental Treatment1 Intervention

VBI-1901 10 μg HCMV pp65 formulated with AS01B (50 μg of QS-21 and 50 μg of MPL per dose) in 1.0 mL volume, given in one IM injection

Group IV: Part A Dose Level 3Experimental Treatment1 Intervention

VBI-1901 high dose (10 μg pp65 content) vaccine formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal intradermal injections

Group V: Part A Dose Level 2Experimental Treatment1 Intervention

VBI-1901 intermediate dose (2 μg pp65 content) vaccine formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal intradermal injections

Group VI: Part A Dose Level 1Experimental Treatment1 Intervention

VBI-1901 low dose (0.4 μg pp65 content) vaccine formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal intradermal injections

Group VII: Part C Standard of Care TreatmentActive Control2 Interventions

Single-agent standard-of-care (SOC) treatment with either carmustine intravenously at a dose of 150 mg/m² or lomustine orally at a dose of 110 mg/m² (up to a maximum dose of 200 mg).

0 / 10Eligibility criteria met

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

Glioblastoma treatments often focus on targeting the cancer cells directly or enhancing the body's immune response to these cells. Traditional treatments include surgery to remove as much of the tumor as possible, followed by radiation therapy and chemotherapy with agents like temozolomide, which damages the DNA of cancer cells, leading to cell death. Immune-based therapies, such as the investigational vaccine VBI-1901, aim to activate the immune system to recognize and attack glioblastoma cells. This approach is significant for patients as it offers a potential method to target residual cancer cells that are not removed by surgery or killed by radiation and chemotherapy, potentially improving outcomes and reducing recurrence.