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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

252

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

August 1, 2015

Primary Completion (Actual)

November 3, 2017

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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