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

Not Recruiting

Trial ID: NCT02511405


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.

Official Title

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

Stanford Investigator(s)

Seema Nagpal, MD
Seema Nagpal, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Reena Thomas, MD PhD
Reena Thomas, MD PhD

Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery


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.


drug: VB-111 + bevacizumab

drug: Bevacizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

New Trial Alerts