A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE) (GLOBE)

October 22, 2018 updated by: Vascular Biogenics Ltd. operating as VBL Therapeutics

A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma

The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Centre
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Centre
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Petach Tikvah, Israel
        • Rabin Medical Center
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama
    • Arizona
      • Rogers, Arizona, United States
        • Highlands Oncology Group
    • California
      • Irvine, California, United States
        • University Of California Irvine Medical Center
      • Los Angeles, California, United States
        • University of California Los Angeles
      • Orangevale, California, United States
        • The Center for Cancer Prevention and Treatment
      • Redwood City, California, United States
        • Kaiser Permanente - Redwood City Medical Center
      • San Diego, California, United States
        • University of California
      • San Francisco, California, United States
        • University of California San Francisco
      • Stanford, California, United States
        • Stanford University
    • Colorado
      • Denver, Colorado, United States
        • Colorado Neurological Institute
    • District of Columbia
      • Washington, District of Columbia, United States
        • The George Washington University Medical Faculty Associates
    • Florida
      • Gainesville, Florida, United States
        • University of Florida Preston A. Wells, Jr. Center for Brain Tumor Therapy
      • Orlando, Florida, United States
        • Orlando Health
    • Georgia
      • Atlanta, Georgia, United States
        • Piedmont Physicians Neuro-Oncology
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
      • Chicago, Illinois, United States
        • The University of Chicago
    • Kansas
      • Kansas City, Kansas, United States
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States
        • University Of Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Shreveport, Louisiana, United States
        • Louisiana State University Health Science Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Metro-MN Community Oncology Research Consortium
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Dartmouth Hitchcock Medical Center
    • New York
      • Amherst, New York, United States
        • Dent Neurosciences Research Center
      • Lake Success, New York, United States
        • North Shore University Hospital
      • New York, New York, United States
        • Columbia University Medical center
      • New York, New York, United States
        • Derald H. Ruttenberg Treatment Center
      • Rochester, New York, United States
        • University of Rochester Medical Center
      • Stony Brook, New York, United States
        • Stony Brook University, Neurology Associates of Stony Brook
      • Syracuse, New York, United States
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina at Chapel Hill
      • Winston-Salem, North Carolina, United States
        • Wake Forest Baptist Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Penn State Milton S Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology-Austin Midtown
      • Dallas, Texas, United States
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States
        • Baylor Health Neuro-Oncology Associates
      • Houston, Texas, United States
        • : University of Texas, HSC
      • Houston, Texas, United States
        • MD Anderson
      • San Antonio, Texas, United States
        • UTHSCSA
    • Utah
      • Salt Lake City, Utah, United States
        • Huntsman Cancer Institute at the University of Utah
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia
    • Washington
      • Seattle, Washington, United States
        • Swedish Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. First or second progression of Glioblastoma;
  2. Measurable disease by RANO criteria at progression;
  3. Patients ≥18 years of age;
  4. Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
  5. Surgery completed at least 28 days before randomization;
  6. An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;
  7. Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;

  8. Adequate renal, liver, and bone marrow function according to the following criteria:

    • Absolute neutrophil count ≥1500 cells/ml,
    • Platelets ≥ 100,000 cells/ml,
    • Total bilirubin within upper limit of normal (ULN),
    • Aspartate aminotransferase (AST) ≤ 2.0 X ULN,
    • Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),
    • PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.

Exclusion Criteria:

  1. Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);
  2. Prior stereotactic radiotherapy;
  3. Pregnant or breastfeeding patients;
  4. Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
  5. Active infection;
  6. Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
  7. Expected to have surgery during study period;
  8. Patients with active vascular disease, either myocardial or peripheral (i.e. acute coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis or symptomatic peripheral vascular disease within the past 3 months);
  9. Patients with known proliferative and/or vascular retinopathy;
  10. Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);
  11. Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening;
  12. Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;
  13. Patients that have undergone major surgery within the last 4 weeks before enrollment;
  14. Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
VB-111 + Bevacizumab
Drug: VB-111 + bevacizumab

VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months

Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks
Active Comparator: Arm 2
Bevacizumab
Drug: Bevacizumab
Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survival
Time Frame: From date of study entry until the date of death from any cause (up to 10 years)
From date of study entry until the date of death from any cause (up to 10 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression Free Survival
Time Frame: To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.
To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.
Tumor response as measured by RANO Criteria
Time Frame: To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.
To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vascular Biogenics Ltd. operating as VBL Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VB-111-215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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