Trial Search Results

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

This research study is evaluating an investigational product called VB-111 as a possible treatment for Glioblastoma Multiforme (GBM). VB-111 is a product developed to diminish cancer cells in body by damaging the blood vessels which grow and nourish the tumor and are essential to its continued existence and growth. If VB-111 is successful in cutting off the blood supply to the tumor, the tumor may not be able to grow.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Vascular Biogenics Ltd. operating as VBL Therapeutics

Stanford Investigator(s):


  • Drug: VB-111 + bevacizumab
  • Drug: Bevacizumab


Phase 3


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

Exclusion Criteria:

   1. Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab,
   aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib,

   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

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting