Glioblastoma
Conditions
Keywords
rGBM, Recurrent Glioblastoma, Recurrent GBM
Brief summary
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.
Interventions
DRUGVB-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
DRUGBevacizumab
Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks
Sponsors
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | From date of study entry until the date of death from any cause (up to 10 years) |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 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 | To be assessed from date of randomization until the date of disease progression, assessed up to 10 years. |
Countries
Canada, Israel, United States
Outcome results
None listed