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

A Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 With Subsequent Extension of Optimal Dose in Recurrent GBM Subjects

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

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Biological: VBI-1901; Drug: Carmustine; Drug: Lomustine

Detailed Description

This is a three-part, dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of optimal dose level in recurrent GBM subjects and comparison with standard of care (SOC) treatment. Subjects in groups receiving VBI-1901 vaccination will continue to receive vaccine every 4 weeks until tumor progression per immunotherapy Response Assessment for Neuro-Oncology (iRANO)/Response Assessment for Neuro-Oncology (RANO) criteria.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Bebi Yassin-Rajkumar, MS; Phone Number: 866-574-7034; Email: BYassin-Rajkumar@vbivaccines.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • Recruiting
      • University of California, Irvine
      • Principal Investigator: Daniela Bota, MD PhD
      • Contact: Manisha Dandekar, MSc, CCRP; Phone Number: 714-456-8350; Email: mdandeka@hs.uci.edu
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Sheila Medina-Torne, MPH; Email: cancercto@ucsd.edu
      • Principal Investigator: Jessica Schulte, MD PhD
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles Neuro-Oncology Program
      • Contact: Emese Filka; Email: EFilka@mednet.ucla.edu
      • Principal Investigator: Timothy F Cloughesy, MD
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford
      • Principal Investigator: Seema Nagpal, MD
      • Contact: Neuro Oncology; Email: ecure-all-neuro-crc@lists.stanford.edu
  • Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute
      • Contact: Juliana Montoya; Phone Number: 786-594-7354; Email: Juliana.Montoya@BaptistHealth.net
      • Principal Investigator: Yazmin Odia, MD
      • Contact: Daylen L Santana; Phone Number: 78528 786-526-2000; Email: DaylenS@baptisthealth.net
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Patrick Mostyn; Phone Number: 617-726-2027; Email: PatrickM_Mostyn@dfci.harvard.edu
      • Principal Investigator: Deborah Forst, MD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Amanda Spearman; Phone Number: 617-632-6520; Email: Amanda_Spearman@DFCI.HARVARD.EDU
      • Principal Investigator: Patrick Wen, MD
      • Contact: Sydney Whorral; Phone Number: 617-632-5299; Email: Sydney_Whorral@DFCI.HARVARD.EDU
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • Recruiting
      • The Valley Hospital - Neurosurgeons of New Jersey
      • Contact: Robyn Chicherchia; Phone Number: 201-634-5792; Email: rchiche@valleyhealth.com
      • Principal Investigator: William Cobb, MD
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • The Neurological Institute of New York Columbia University Medical Center
      • Contact: Lisa Olmos; Phone Number: 212-342-5162; Email: lo2345@cumc.columbia.edu
      • Principal Investigator: Andrew B Lassman, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Neuro Oncology Team; Phone Number: 800-811-8480; Email: cip@vumc.org
      • Principal Investigator: Ryan Merrell, MD
  • Washington
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Providence - Swedish Medical Center
      • Principal Investigator: Alipi Bonm, MD
      • Contact: Mark Loreen; Phone Number: 206-320-7121; Email: mark.loreen@swedish.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

PART A DOSE ESCALATION

Inclusion Criteria: Part A Dose Escalation

1. 18-70 years of age
2. Histologically confirmed WHO grade IV glioblastoma
3. Unequivocal evidence of a tumor recurrence (any number of recurrences) or progression after an initial treatment regimen (prior to enrollment on this study) as assessed by MRI of the brain with and without contrast within 30 days prior to the initiation of injections of VBI-1901. An initial therapy requires surgery and radiation therapy, with or without temozolomide. In addition, alternate therapy (with or instead of temozolomide) is permitted as part of initial therapy.
4. Recovery from the effects of surgery.
5. Corticosteroid (dexamethasone or equivalent) dosage ≤ 4mg daily that has been stable or decreasing for at least 5 days.
6. Recovery from prior therapy toxicity defined as resolution of all treatment-related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia).
7. Karnofsky performance status (KPS) score ≥ 70%.

8. Adequate organ function, including the following:

   1. Absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 100,000/μL
   2. Serum creatinine < 1.5 × the upper limit of normal (ULN)
   3. Bilirubin < 1.5 × ULN
   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN
9. Women of childbearing potential: negative urine pregnancy test within 14 days prior to the start of VBI-1901 treatment.
10. 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 >30 days before Screening, during the study, and for 60 days after the last dose of study drug).
11. 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.
12. Able and willing to comply with protocol requirements in the opinion of the Investigator, including being able to have an MRI.
13. Written consent has been obtained.
14. Tumor specimen available for central pathological review.

Exclusion Criteria: Part A Dose Escalation

1. Contrast-enhancing residual tumor that is associated with either diffuse sub-ependymal or leptomeningeal dissemination.
2. Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of VBI-1901 treatment.
3. Evidence of HCMV viremia in serum of > 18,200 (4.3Log10) IU/mL using FDA approved COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).
4. Surgical resection or major surgical procedure within 4 days prior to the start of VBI-1901, or stereotactic biopsy within 7 days prior to the start of VBI-1901.
5. Active infection requiring intravenous antibiotics or antiviral.
6. History of cancer (other than GBM or prostate) within the past 2 years that could negatively impact survival and/or potentially confound tumor response assessments within this study.
7. 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.
8. Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.
9. Evidence of intra-tumoral or peri-tumoral hemorrhage on baseline, other than those that are ≤Grade 1 and either post-operative or stable on at least 2 consecutive MRI scans.
10. Any condition which in the investigator's opinion makes the subject unsuitable for study participation.
11. Lack of family or social support structure that would preclude continued participation in the study.

PART B OPTIMAL DOSE

Inclusion Criteria: Part B Optimal Dose

1. 18-70 years of age.
2. Histologically confirmed WHO grade IV glioblastoma.
3. Unequivocal evidence of a first tumor recurrence with measurable disease, of an area no greater than 400 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 within 30 days prior to the initiation of injections of VBI-1901. In addition, alternate chemotherapy (with or instead of temozolomide) is permitted as part of initial therapy.
4. At least 12 weeks since radiotherapy treatment and/or 23 days after chemotherapy prior to first dose of VBI-1901.
5. Recovery from the effects of surgery.
6. Corticosteroid (dexamethasone or equivalent) dosage ≤ 4mg daily that has been stable or decreasing for at least 5 days.
7. Recovery from prior therapy toxicity, defined as resolution of all treatment-related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia).
8. Karnofsky performance status (KPS) score ≥ 70%.

9. Adequate organ function, including the following:

   1. Absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 100,000/μL; absolute lymphocyte count ≥ 500/uL;
   2. Serum creatinine < 1.5 × the upper limit of normal (ULN);
   3. Bilirubin < 1.5 × ULN;
   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
10. Women of childbearing potential must have a negative urine pregnancy test within 14 days prior to the start of VBI-1901 treatment.
11. 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 > 30 days before Screening, during the study, and for 60 days after the last dose of study drug).
12. 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.
13. Able and willing to comply with protocol requirements, in the opinion of the Investigator.
14. Written consent has been obtained.
15. Tumor specimen available for central pathological review.

Exclusion Criteria: Part B Optimal Dose

1. Contrast-enhancing residual tumor that is any of the following:

   1. An area greater than 400mm2;
   2. Multi-focal (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);
   3. Associated with either diffuse sub-ependymal or leptomeningeal dissemination.
2. IDH1/2 has been proven to be mutated by IHC or PCR or if recurrent GBM was previously a lower grade glioma and wildtype IDH1/2 status has not been confirmed.
3. Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of VBI-1901 treatment.
4. Evidence of HCMV viremia in plasma of >18,200 (4.3log10) IU/mL using FDA approved COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).
5. Prior treatment involving immunotherapy, including oncolytic viruses, therapeutic vaccination, or biologics (e.g. monoclonal antibodies, such as bevacizumab) presumed to have immunomodulatory effects.
6. Surgical resection or major surgical procedure within 14 days prior to the start of VBI-1901, or stereotactic biopsy within 14 days prior to the start of VBI-1901.
7. 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 convection- enhanced delivery administered agents, etc.
8. Concurrent therapy with Optune® or use within 1 week of start of treatment with VBI-1901.
9. Active infection requiring intravenous antibiotics or antivirals.
10. 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.
11. 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.
12. Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.
13. Any severe adverse event or allergy suspected or attributed to the shingles vaccines that contains AS01B components.
14. 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.
15. Any condition which in the investigator's opinion makes the subject unsuitable for study participation.
16. Lack of family or social support structure that would preclude continued participation in the study.

PART C RANDOMIZED OPEN-LABEL STUDY EXTENSION

INCLUSION CRITERIA

1. 18 years of age or older (no age upper limit).
2. 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.
3. 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.

4. 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).

5. Recovery from the effects of surgery.
6. Corticosteroid (dexamethasone or equivalent) dosage ≤ 2 mg daily that has been stable for at least 5 days before randomization into the study.
7. Recovery from prior therapy toxicity, defined as resolution of all treatment related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia).
8. Karnofsky performance status (KPS) score ≥70%.

9. Adequate organ function, including the following:

   1. 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;
   2. Serum creatinine < 1.5 × the upper limit of normal (ULN);
   3. Bilirubin < 1.5 × ULN;
   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
10. Women of childbearing potential must have a negative urine pregnancy test within 21 days prior to the start of treatment.
11. 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).
12. 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.
13. Able and willing to comply with protocol requirements, in the opinion of the Investigator.
14. Written consent has been obtained.

EXCLUSION CRITERIA:

1. Contrast-enhancing residual tumor that is any of the following:

   1. An area greater than 600 mm2;
   2. 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);
   3. Associated with either diffuse sub-ependymal or leptomeningeal dissemination.
2. If recurrent GBM was previously a lower grade glioma and wildtype IDH1/2 status has not been confirmed.
3. Requirement of systemic corticosteroid therapy > 2 mg/day of dexamethasone or equivalent during the 5 days prior to the start of treatment.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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).
9. 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.
10. Active infection requiring intravenous antibiotics or antivirals.
11. 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.
12. 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.
13. Any known allergies to the ingredients of VBI-1901 or GM-CSF or carmustine or lomustine.
14. 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.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Dose Level 1; 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	Biological: VBI-1901; The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.
Experimental: Part A Dose Level 2; 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	Biological: VBI-1901; The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.
Experimental: Part A Dose Level 3; 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	Biological: VBI-1901; The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.
Experimental: Part B GM-CSF Adjuvant; 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.	Biological: VBI-1901; The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.
Experimental: Part B AS01B Adjuvant; 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	Biological: VBI-1901; The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.
Active Comparator: Part C Standard of Care Treatment; 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).	Drug: Carmustine; Treatment with carmustine intravenously at a dose of 150 mg/m² on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.; Other Names: BiCNU; Drug: Lomustine; Treatment with lomustine given orally at a dose of 110 mg/m² (up to a maximum dose of 200 mg) on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.; Other Names: Gleostine
Experimental: Part C VBI-1901 with GM-CSF Adjuvant; VBI-1901 10 μg HCMV pp65 formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal ID injections.	Biological: VBI-1901; The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose limiting toxicity (DLT) occurring during Part A of the study	Through 14 days after each study vaccination
Occurrence of AEs during each treatment cycle	Through 28 days after each study vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum antibody immune response	Assessment of IgG antibody to HCMV gB antigen by ELISA	Baseline and 2 weeks after each dose of vaccine in Part A and Part B and every 3 months in Part C
Cellular immune responses	Assessment of IFN-γ and IL-5 positive peripheral blood mononuclear cells by ELISPOT	Baseline and 2 weeks after each dose of vaccine in Part A and Part B and every 3 months in Part C
Progression free survival (PFS)	Progression free survival (PFS) from date of first dose to date of progression (per iRANO/RANO criteria) or death, as well as at 6, 12, 18 and 24 months.	From the date of first dose to date of progression or death, as well as at 6, 12, 18 and 24 months
Overall survival (OS)		6, 12, 18 and 24 months from date of first dose
Median overall survival in Part A and Part B of the study		Date of first dose to date of death from any cause, assessed up to 18 months
Reduction in steroid use compared to baseline		Baseline to study completion, an average of 12 months
Change in quality of life (QOL questionnaire) compared to baseline		Baseline to study completion, an average of 12 months
Tumor response rates (TRR) in Part C of the study	Complete response rate, partial response rate, progressive disease and stable disease	Baseline to study completion, an average of 12 months
Safety and efficacy of VBI-1901 compared to standard of care (SOC) in Part C of study	An integrated analysis of safety and efficacy (OS, TRR, PFS) in subjects receiving VBI-1901 at 10 µg dose formulated with GM-CSF as compared to subjects receiving SOC	Baseline to study completion, an average of 12 months

Collaborators and Investigators

• Sponsor: VBI Vaccines Inc.
• Investigators: Study Director: Francisco Diaz-Mitoma, MD, Variation Biotechnologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; immunotherapy; vaccine; GBM; Brain; CMV; Glioblastoma; CNS; eVLP; VBI-1901
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Carmustine; Lomustine
• Other Study ID Numbers: VBI-1901-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No