A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE) (GLOBE)
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| ClinicalTrials.gov Identifier: NCT02511405 |
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Recruitment Status :
Completed
First Posted : July 30, 2015
Last Update Posted : October 23, 2018
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Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma | Drug: VB-111 + bevacizumab Drug: Bevacizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 252 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | August 2015 |
| Actual Primary Completion Date : | November 3, 2017 |
| Actual Study Completion Date : | September 30, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Bevacizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1
VB-111 + Bevacizumab
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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 |
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Active Comparator: Arm 2
Bevacizumab
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Drug: Bevacizumab
Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks |
Primary Outcome Measures :
- Overall survival [ Time Frame: From date of study entry until the date of death from any cause (up to 10 years) ]
Secondary Outcome Measures :
- Progression Free Survival [ Time Frame: 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 [ Time Frame: To be assessed from date of randomization until the date of disease progression, assessed up to 10 years. ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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%;
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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:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511405
Locations
Show 57 study locations
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vascular Biogenics Ltd. operating as VBL Therapeutics |
| ClinicalTrials.gov Identifier: | NCT02511405 |
| Other Study ID Numbers: |
VB-111-215 |
| First Posted: | July 30, 2015 Key Record Dates |
| Last Update Posted: | October 23, 2018 |
| Last Verified: | January 2017 |
Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
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rGBM Recurrent Glioblastoma Recurrent GBM |
Additional relevant MeSH terms:
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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |