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

Stopped early · Phase 1/Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects with recurrent malignant gliomas (glioblastoma, or GBM).

Key facts

Study ID

NCT03382977

Run by

VBI Vaccines Inc.

People needed

70

Starts

2017-12-06

Expected to finish

2025-08-30

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older (no age upper limit).
• Histologically confirmed supratentorial 2016 WHO classification grade IV Glioblastoma, IDH-wildtype or grade 4 in the 2021 WHO classification. Tumors that are histologically lower grade but are classified as glioblastoma using the WHO 2021 criteria because of molecular alterations (TERT promoter mutation and/or EGFR amplification and/or combined chromosome 7 gain/10 loss) are not eligible.
• Unequivocal evidence of a first tumor recurrence with measurable disease of an area no greater than 600 mm2, which may include patients with resected first recurrence tumor, after an initial treatment regimen (prior to enrollment on this study) consisting of surgical intervention (tumor resection) and radiation, with or without temozolomide chemotherapy (depending on the MGMT methylation status), as assessed by MRI of the brain with and without contrast completed within 30 days prior to screening visit, if not it should be performed as part of screening visit. In addition, alternate bio/chemotherapy (with or instead of temozolomide) other than nitrosourea is permitted as part of initial therapy.
• At least 12 weeks since radiotherapy treatment and/or 23 days after chemotherapy prior to first dose of VBI-1901 or SOC treatment. Patients with recurrent GBM within 12 weeks of radiation therapy may be included if they have surgically proven tumor recurrence (i.e.
• this is proven to not be pseudoprogression).
• Recovery from the effects of surgery.
• Corticosteroid (dexamethasone or equivalent) dosage ≤ 2 mg daily that has been stable for at least 5 days before randomization into the study.
• Recovery from prior therapy toxicity, defined as resolution of all treatment related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia).
• Karnofsky performance status (KPS) score ≥70%.
• Adequate organ function, including the following:
• Absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 100,000/μL; Absolute lymphocyte count ≥ 500/uL; CD4/CD8 ratio ≥1 or CD4 count ≥ 400/uL;
• Serum creatinine < 1.5 × the upper limit of normal (ULN);
• Bilirubin < 1.5 × ULN;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
• Women of childbearing potential must have a negative urine pregnancy test within 21 days prior to the start of treatment.
• Female subjects of childbearing potential and sexually active male subjects must agree to use an acceptable form of contraception for heterosexual activity (i.e., oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 40 days before Screening, during the study, and for 60 days after the last dose of study drug).
• Female subjects without childbearing potential (spontaneous amenorrhea for >12 months or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy > 6 months before Screening) are eligible for inclusion without contraceptive use restriction.
• Able and willing to comply with protocol requirements, in the opinion of the Investigator.
• Written consent has been obtained.

You may not qualify if…

• Contrast-enhancing residual tumor that is any of the following:
• An area greater than 600 mm2;
• Multicentric (defined as two separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid-attenuated inversion recovery (FLAIR) or T2 sequences);
• Associated with either diffuse sub-ependymal or leptomeningeal dissemination.
• If recurrent GBM was previously a lower grade glioma and wildtype IDH1/2 status has not been confirmed.
• Requirement of systemic corticosteroid therapy > 2 mg/day of dexamethasone or equivalent during the 5 days prior to the start of treatment.
• Evidence of HCMV viremia in plasma of > 18,200 (4.3log10) IU/mL using FDA approved COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche) or other qualified HCMV assay.
• Prior treatment involving immunotherapy, including oncolytic viruses, therapeutic vaccination, or biologics presumed to have immunomodulatory effects. Prior bevacizumab therapy is allowed, requiring at least 28 days washout period before randomization.
• Surgical resection or major surgical procedure within 14 days prior to the start of treatment, or stereotactic biopsy within 7 days prior to the start of treatment.
• Radiation therapy, local therapy (except for surgical re-resection), or systemic therapy following first recurrence/progressive disease. Excluded local therapies include stereotactic radiation boost, implantation of carmustine biodegradable wafers (Gliadel), intratumoral or convectionenhanced delivery administered agents, etc.
• More than 1 (one) line of prior chemotherapy (as an example, temozolomide given with radiotherapy and after radiotherapy before recurrence is considered a single line).
• Concurrent therapy with Optune® or use within 1 week of start of treatment. Previous use of Optune® in the primary setting does not preclude participation in this clinical trial.
• Active infection requiring intravenous antibiotics or antivirals.
• History of cancer (other than GBM or prostate) within the past 2 years that has metastatic or local recurrence potential and could negatively impact survival and/or potentially confound tumor response assessments within this study.
• Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Any known allergies to the ingredients of VBI-1901 or GM-CSF or carmustine or lomustine.
• Evidence of intra- or peri-tumoral hemorrhage on baseline MRI scan, other than those that are ≤Grade 1 and either post-operative or stable on at least 2 consecutive MRI scans.
• Any medical or social condition which in the investigator's opinion makes the subject unsuitable for study participation. For instance, lack of family or social support structure that would preclude continued participation in the study.

Where it is running

• University of California, Irvine — Irvine, California, United States
• University of California, San Diego — La Jolla, California, United States
• University of California, Los Angeles Neuro-Oncology Program — Los Angeles, California, United States
• Stanford — Stanford, California, United States
• Miami Cancer Institute — Miami, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• The Valley Hospital - Neurosurgeons of New Jersey — Ridgewood, New Jersey, United States
• The Neurological Institute of New York Columbia University Medical Center — New York, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Providence - Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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