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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 18 and 24 months from date of first dose
Awards & highlights

Study Summary

This trial will test a new drug, VBI-1901, on people with brain tumors to see if it is safe and effective.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 18 and 24 months from date of first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 18 and 24 months from date of first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT) occurring during Part A of the study
Therapeutic procedure
Secondary outcome measures
Cellular immune responses
Change in quality of life (QOL questionnaire) compared to baseline
Median overall survival in Part A and Part B of the study
+6 more

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).

Find a Location

Who is running the clinical trial?

VBI Vaccines Inc.Lead Sponsor
11 Previous Clinical Trials
5,594 Total Patients Enrolled
Francisco Diaz-Mitoma, MDStudy DirectorVariation Biotechnologies Inc.

Media Library

VBI-1901 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03382977 — Phase 1 & 2
Glioblastoma Clinical Trial 2023: VBI-1901 Highlights & Side Effects. Trial Name: NCT03382977 — Phase 1 & 2
VBI-1901 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03382977 — Phase 1 & 2
Glioblastoma Research Study Groups: Part A Dose Level 1, Part A Dose Level 2, Part A Dose Level 3, Part B GM-CSF Adjuvant, Part B AS01B Adjuvant, Part C VBI-1901 with GM-CSF Adjuvant, Part C Standard of Care Treatment

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you walk me through the screening process for this research project?

"This clinical trial is looking for 98 patients that have been diagnosed with glioblastoma multiforme. The ideal candidate will be between 18 and 70 years of age and must meet the following criteria: a Karnofsky performance status score of ≥ 70%, prior surgery and radiation therapy, stable or decreasing corticosteroid dosage ≤ 4mg daily for at least 5 days, resolution of all treatment-related adverse events to Grade ≤ 1 or pre-treatment baseline, absolute neutrophil count ≥ 1,000/μL, and platelets ≥ 100,000/μL."

Answered by AI

Does this test allow for subjects who are geriatric?

"According to the inclusion criteria, patients who want to enroll in this trial must be aged between 18 and 70. However, there are 35 trials for patients under the age of 18 and 431 for people over 65."

Answered by AI

Would it be possible to join this clinical trial at its current stage?

"No, this study is not currently looking for participants. According to the most recent update on clinicaltrials.gov (June 27th, 2022), this research was first posted on December 6th, 2017. There are 458 other studies that are presently recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
2017. "Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03382977.
All > Glioblastoma Long Beach > Vaccine
~15 spots leftby Jul 2025
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