Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-06 @ 6:14 PM
Study NCT ID:
NCT02511405
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of study entry until the date of death from any cause (up to 10 years)'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.'}, {'measure': 'Tumor response as measured by RANO Criteria', 'timeFrame': 'To be assessed from date of randomization until the date of disease progression, assessed up to 10 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rGBM', 'Recurrent Glioblastoma', 'Recurrent GBM'], 'conditions': ['Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '37540556', 'type': 'DERIVED', 'citation': 'Ellingson BM, Hagiwara A, Morris CJ, Cho NS, Oshima S, Sanvito F, Oughourlian TC, Telesca D, Raymond C, Abrey LE, Garcia J, Aftab DT, Hessel C, Rachmilewitz Minei T, Harats D, Nathanson DA, Wen PY, Cloughesy TF. Depth of Radiographic Response and Time to Tumor Regrowth Predicts Overall Survival Following Anti-VEGF Therapy in Recurrent Glioblastoma. Clin Cancer Res. 2023 Oct 13;29(20):4186-4195. doi: 10.1158/1078-0432.CCR-23-1235.'}, {'pmid': '31844890', 'type': 'DERIVED', 'citation': 'Cloughesy TF, Brenner A, de Groot JF, Butowski NA, Zach L, Campian JL, Ellingson BM, Freedman LS, Cohen YC, Lowenton-Spier N, Rachmilewitz Minei T, Fain Shmueli S; GLOBE Study Investigators; Wen PY. A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE). Neuro Oncol. 2020 May 15;22(5):705-717. doi: 10.1093/neuonc/noz232.'}], 'seeAlsoLinks': [{'url': 'http://www.vblrx.com', 'label': 'VBL Therapeutics Company Website'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. First or second progression of Glioblastoma;\n2. Measurable disease by RANO criteria at progression;\n3. Patients ≥18 years of age;\n4. Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;\n5. Surgery completed at least 28 days before randomization;\n6. 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;\n7. Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;\n8. Adequate renal, liver, and bone marrow function according to the following criteria:\n\n * Absolute neutrophil count ≥1500 cells/ml,\n * Platelets ≥ 100,000 cells/ml,\n * Total bilirubin within upper limit of normal (ULN),\n * Aspartate aminotransferase (AST) ≤ 2.0 X ULN,\n * 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),\n * PT, PTT (in seconds) not to be prolonged beyond \\>20% of the upper limits of normal.\n\nExclusion Criteria:\n\n1. Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);\n2. Prior stereotactic radiotherapy;\n3. Pregnant or breastfeeding patients;\n4. Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;\n5. Active infection;\n6. Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;\n7. Expected to have surgery during study period;\n8. 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);\n9. Patients with known proliferative and/or vascular retinopathy;\n10. Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);\n11. 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;\n12. Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;\n13. Patients that have undergone major surgery within the last 4 weeks before enrollment;\n14. Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.'}, 'identificationModule': {'nctId': 'NCT02511405', 'acronym': 'GLOBE', 'briefTitle': 'A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vascular Biogenics Ltd. operating as VBL Therapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'VB-111-215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'VB-111 + Bevacizumab', 'interventionNames': ['Drug: VB-111 + bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Bevacizumab', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'VB-111 + bevacizumab', 'type': 'DRUG', 'description': 'VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months\n\nBevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks', 'armGroupLabels': ['Arm 1']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Rogers', 'state': 'Arizona', 'country': 'United States', 'facility': 'Highlands Oncology Group'}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Orangevale', 'state': 'California', 'country': 'United States', 'facility': 'The Center for Cancer Prevention and Treatment', 'geoPoint': {'lat': 38.67851, 'lon': -121.22578}}, {'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - Redwood City Medical Center', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The George Washington University Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Preston A. Wells, Jr. Center for Brain Tumor Therapy', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Physicians Neuro-Oncology', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Science Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro-MN Community Oncology Research Consortium', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Dent Neurosciences Research Center', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Derald H. Ruttenberg Treatment Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University, Neurology Associates of Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Austin Midtown', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Health Neuro-Oncology Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': ': University of Texas, HSC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UTHSCSA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute at The University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petach Tikvah', 'country': 'Israel', 'facility': 'Rabin Medical Center'}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vascular Biogenics Ltd. operating as VBL Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}