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

Completed · Phase 3

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT02511405

Run by

Vascular Biogenics Ltd. operating as VBL Therapeutics

People needed

252

Starts

2015-08-01

Expected to finish

2018-09-30

Last updated by the study team

2018-10-23

Who can join

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

You may qualify if…

• First or second progression of Glioblastoma;
• Measurable disease by RANO criteria at progression;
• Patients ≥18 years of age;
• Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
• Surgery completed at least 28 days before randomization;
• 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;
• Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;
• 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.

You may not qualify if…

• Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);
• Prior stereotactic radiotherapy;
• Pregnant or breastfeeding patients;
• Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
• Active infection;
• Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
• Expected to have surgery during study period;
• 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);
• Patients with known proliferative and/or vascular retinopathy;
• Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);
• 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;
• Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;
• Patients that have undergone major surgery within the last 4 weeks before enrollment;
• Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.

Where it is running

• Highlands Oncology Group — Rogers, Arizona, United States
• University of California Irvine Medical Center — Irvine, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• The Center for Cancer Prevention and Treatment — Orangevale, California, United States
• Kaiser Permanente - Redwood City Medical Center — Redwood City, California, United States
• University of California — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Colorado Neurological Institute — Denver, Colorado, United States
• The George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• University of Florida Preston A. Wells, Jr. Center for Brain Tumor Therapy — Gainesville, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Piedmont Physicians Neuro-Oncology — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• The University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Louisiana State University Health Science Center — Shreveport, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Metro-MN Community Oncology Research Consortium — Minneapolis, Minnesota, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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