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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02511405
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Vascular Biogenics Ltd. operating as VBL Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Canada, Israel, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Arm 1

VB-111 + Bevacizumab

Active Comparator: Arm 2

Bevacizumab

Interventions

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

Drug: - Bevacizumab

Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama, Birmingham, Alabama

Status

Address

University of Alabama

Birmingham, Alabama,

Highlands Oncology Group, Rogers, Arizona

Status

Address

Highlands Oncology Group

Rogers, Arizona,

Irvine, California

Status

Address

University of California Irvine Medical Center

Irvine, California,

University of California Los Angeles, Los Angeles, California

Status

Address

University of California Los Angeles

Los Angeles, California,

Orangevale, California

Status

Address

The Center for Cancer Prevention and Treatment

Orangevale, California,

Redwood City, California

Status

Address

Kaiser Permanente - Redwood City Medical Center

Redwood City, California,

University of California, San Diego, California

Status

Address

University of California

San Diego, California,

University of California San Francisco, San Francisco, California

Status

Address

University of California San Francisco

San Francisco, California,

Stanford University, Stanford, California

Status

Address

Stanford University

Stanford, California,

Colorado Neurological Institute, Denver, Colorado

Status

Address

Colorado Neurological Institute

Denver, Colorado,

Washington, District of Columbia

Status

Address

The George Washington University Medical Faculty Associates

Washington, District of Columbia,

Gainesville, Florida

Status

Address

University of Florida Preston A. Wells, Jr. Center for Brain Tumor Therapy

Gainesville, Florida,

Orlando Health, Orlando, Florida

Status

Address

Orlando Health

Orlando, Florida,

Piedmont Physicians Neuro-Oncology, Atlanta, Georgia

Status

Address

Piedmont Physicians Neuro-Oncology

Atlanta, Georgia,

Northwestern University, Chicago, Illinois

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Address

Northwestern University

Chicago, Illinois,

The University of Chicago, Chicago, Illinois

Status

Address

The University of Chicago

Chicago, Illinois,

University of Kansas Medical Center, Kansas City, Kansas

Status

Address

University of Kansas Medical Center

Kansas City, Kansas,

University of Kentucky, Lexington, Kentucky

Status

Address

University of Kentucky

Lexington, Kentucky,

University of Louisville, Louisville, Kentucky

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Address

University of Louisville

Louisville, Kentucky, 40202

Shreveport, Louisiana

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Address

Louisiana State University Health Science Center

Shreveport, Louisiana,

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts,

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts,

Ann Arbor, Michigan

Status

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan,

Henry Ford Health System, Detroit, Michigan

Status

Address

Henry Ford Health System

Detroit, Michigan,

Minneapolis, Minnesota

Status

Address

Metro-MN Community Oncology Research Consortium

Minneapolis, Minnesota, 55416

Washington University School of Medicine, Saint Louis, Missouri

Status

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Address

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire,

Dent Neurosciences Research Center, Amherst, New York

Status

Address

Dent Neurosciences Research Center

Amherst, New York,

North Shore University Hospital, Lake Success, New York

Status

Address

North Shore University Hospital

Lake Success, New York,

Columbia University Medical Center, New York, New York

Status

Address

Columbia University Medical Center

New York, New York,

Derald H. Ruttenberg Treatment Center, New York, New York

Status

Address

Derald H. Ruttenberg Treatment Center

New York, New York,

University of Rochester Medical Center, Rochester, New York

Status

Address

University of Rochester Medical Center

Rochester, New York,

Stony Brook, New York

Status

Address

Stony Brook University, Neurology Associates of Stony Brook

Stony Brook, New York,

SUNY Upstate Medical University, Syracuse, New York

Status

Address

SUNY Upstate Medical University

Syracuse, New York,

Chapel Hill, North Carolina

Status

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina,

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

Status

Address

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina,

Hershey, Pennsylvania

Status

Address

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania,

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania,

Texas Oncology-Austin Midtown, Austin, Texas

Status

Address

Texas Oncology-Austin Midtown

Austin, Texas, 78705

Baylor Health Neuro-Oncology Associates, Dallas, Texas

Status

Address

Baylor Health Neuro-Oncology Associates

Dallas, Texas,

Dallas, Texas

Status

Address

University of Texas Southwestern Medical Center

Dallas, Texas,

: University of Texas, HSC, Houston, Texas

Status

Address

: University of Texas, HSC

Houston, Texas,

MD Anderson, Houston, Texas

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Address

MD Anderson

Houston, Texas,

UTHSCSA, San Antonio, Texas

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Address

UTHSCSA

San Antonio, Texas,

Salt Lake City, Utah

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Address

Huntsman Cancer Institute at The University of Utah

Salt Lake City, Utah,

University of Virginia, Charlottesville, Virginia

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Address

University of Virginia

Charlottesville, Virginia,

Swedish Medical Center, Seattle, Washington

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Address

Swedish Medical Center

Seattle, Washington,

University of Wisconsin, Madison, Wisconsin

Status

Address

University of Wisconsin

Madison, Wisconsin,

International Sites

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Status

Address

Tom Baker Cancer Centre

Calgary, Alberta,

London Health Sciences Centre, London, Ontario, Canada

Status

Address

London Health Sciences Centre

London, Ontario,

Ottawa Hospital, Ottawa, Ontario, Canada

Status

Address

Ottawa Hospital

Ottawa, Ontario,

Sunnybrook Health Science Centre, Toronto, Ontario, Canada

Status

Address

Sunnybrook Health Science Centre

Toronto, Ontario,

Rambam Medical Center, Haifa, Israel

Status

Address

Rambam Medical Center

Haifa, ,

Hadassah Medical Center, Jerusalem, Israel

Status

Address

Hadassah Medical Center

Jerusalem, ,

Rabin Medical Center, Petach Tikvah, Israel

Status

Address

Rabin Medical Center

Petach Tikvah, ,

Chaim Sheba Medical Center, Ramat Gan, Israel

Status

Address

Chaim Sheba Medical Center

Ramat Gan, ,

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, ,

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