Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Patients with Recurrent Glioblastoma

Sponsor: VBI Vaccines Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03382977

Provider View

This clinical trial is testing a new vaccine, VBI-1901, to see if it is safe and well-tolerated in patients with recurrent glioblastoma, a type of brain cancer. The study aims to find the best dose of the vaccine and compare it with standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and tolerability of the VBI-1901 vaccine in patients with recurrent glioblastoma (GBM), a type of aggressive brain cancer. The study will test different doses of the vaccine to find the most effective one and will compare the results with standard care treatments. Participants will receive the vaccine every four weeks until their tumor progresses, as determined by specific medical criteria.

Description

This study is divided into three parts to determine the safety, tolerability, and best dose of the VBI-1901 vaccine for patients with recurrent glioblastoma (GBM). Participants will receive the vaccine every four weeks until their tumor shows signs of progression. The study will also compare the vaccine's effectiveness with standard treatments for GBM.

In the first part, different doses of the vaccine will be tested to find the safest and most effective dose. In the second part, the optimal dose will be given to more patients to further assess its safety and effectiveness. In the third part, the study will be open-label, meaning both the researchers and participants will know which treatment is being given.

Participants must meet certain criteria to join the study, such as being between 18 and 70 years old, having a confirmed diagnosis of glioblastoma, and showing evidence of tumor recurrence. They must also have recovered from previous treatments and have stable health conditions. Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting the treatment.

The study will exclude individuals with certain conditions, such as those requiring high doses of steroids, having active infections, or having other types of cancer within the past two years. Participants must also not have any medical or social conditions that would prevent them from completing the study.

Eligibility Criteria

Inclusion Criteria

  • Aged 18 to 70 years old.
  • Diagnosed with grade IV glioblastoma.
  • Evidence of tumor recurrence after initial treatment, confirmed by MRI.
  • Recovered from surgery and previous treatments.
  • Stable or decreasing steroid dosage of 4mg or less daily.
  • Good overall health with a performance status score of 70% or higher.
  • Adequate organ function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Willing to comply with study requirements and provide written consent.
  • Tumor sample available for review.

Exclusion Criteria

  • Tumor spread to certain areas of the brain or spinal cord.
  • Need for high doses of steroids or increasing steroid dosage.
  • Active infections requiring intravenous treatment.
  • History of other cancers within the past two years.
  • Known autoimmune or immunosuppressive diseases.
  • Recent major surgery or biopsy.
  • Previous treatment with certain immunotherapies.
  • Any condition that makes participation unsuitable, as judged by the investigator.

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