[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509145":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":70,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":12,"enrollmentInfo":87,"targetDuration":12,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":12,"overallStatus":53,"whyStopped":12,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,13,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 metastatic melanoma with brain metastases who failed immunotherapy","EXPERIMENTAL","The first 3 subjects enrolled to Cohort 1 and Cohort 2 will receive crizanlizumab 5 mg\u002Fkg at Cycle 1 Day 1 (C1D1) and C1D15 followed by crizanlizumab 5 mg\u002Fkg every 4 weeks until disease progression The subsequent 8 patients will receive crizanlizumab 5 mg\u002Fkg at C1D1 and C1D15 followed by 5 mg\u002Fkg every 4 weeks plus nivolumab 3mg\u002Fkg every 2 weeks until disease progression",null,{"label":14,"type":10,"description":11,"interventionNames":15},"Cohort 2 - Patients with recurrent or progressing GB following radiation and temozolamide.",[16,17],"Drug: Crizanlizumab-Tmca 10 MG\u002F1 ML Intravenous Solution [ADAKVEO]","Drug: Nivolumab 10 MG\u002F1 ML Intravenous Solution [OPDIVO]",{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: Patients with newly diagnosed GB","crizanlizumab starting from 4 weeks after completing radiation therapy. The first 2 subjects will receive crizanlizumab 2.5 mg\u002Fkg at C1D1 and C1D15 followed by crizanlizumab 5 mg\u002Fkg every 4 weeks. The subsequent 6 subjects will receive crizanlizumab 5 mg\u002Fkg at C1D1 and C1D15 followed by crizanlizumab every 4 weeks. Treatment will continue for up to 12 months or until disease progression or unacceptable toxicity.",[16],[23,30],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Crizanlizumab-Tmca 10 MG\u002F1 ML Intravenous Solution [ADAKVEO]","5 mg\u002Fkg solution for injection",[14,19],[29],"crizanlizumab",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Nivolumab 10 MG\u002F1 ML Intravenous Solution [OPDIVO]","3 mg\u002FmL solution for injection",[14],[35],"nivolumab",[37],{"name":38,"affiliation":39,"role":40},"Ronnie Shapira Frommer, Dr","Ronnie Shapira, MD Study Principal Investigator Ronnie.Shapira@sheba.health.gov.il","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":12,"email":45},"CONTACT","972-3-5302243","ronnie.shapira@sheba.health.gov.il",{"name":47,"role":43,"phone":48,"phoneExt":12,"email":49},"Meital Bar","972-3-5305201","meital.bar@sheba.health.gov.il",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":12,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Sheba medical center","RECRUITING","Ramat Gan","Israel","IL",{"type":58,"coordinates":59},"Point",[60,61],34.81065,32.08227,{"lat":61,"lon":60},[64,67,68],{"name":65,"role":43,"phone":12,"phoneExt":12,"email":66},"Ronnie Shapira, MD","Ronnie.Shapira@sheba.health.gov",{"name":47,"role":43,"phone":48,"phoneExt":12,"email":49},{"name":69,"role":40,"phone":12,"phoneExt":12,"email":12},"Ronnie Shapira",{"type":40,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Dr. Ronnie Shapira","M.D, Head onco-gynecological service, Principal Investigator",[74],{"name":75,"class":76},"Prof. Ronit Satchi-Fainaro, Director, Cancer Biology Research Center, Tel Aviv University, Tel Aviv, Israel.","UNKNOWN","100509145","phase-2-crizanlizumab-alone-or-in-combination-with-nivolumab-for-glioblastoma-and-melanoma-with-brain-metastases-100509145",false,"NCT05909618","Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases","An Open Label Phase 2 Study of Intravenously Administered Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases","14","Cohort 1 (MBM) Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Estimated life expectancy at least 3 months\n3. Have metastatic melanoma with primarily diagnosed or newly progressing brain metastases.\n4. Was treated with 1 prior systemic line of immunotherapy - either PD-1 inhibitor monotherapy or combined CTLA4 and PD-1 antibodies or another investigational combination of immunotherapy. Patients with BRAF-mutant melanoma who have also received BRAF mutation targeted therapy are also eligible.\n5. Have failed prior immunotherapy line, either due to primary resistance or acquired resistance.\n6. Have measurable disease defined by RECIST criteria and have at least one, non-previously irradiated brain metastasis of at least 1-cm short diameter. Otherwise, previously irradiated lesions should present with enlargement following radiation therapy.\n7. Is clinically stable with no neurological deficits. Patients may receive steroid supportive therapy up to 10 mg of prednisone or the equivalent.\n8. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n9. Adequate organ function defined by blood tests for blood count and chemistry.\n10. Women of childbearing potential practicing an acceptable method of birth control.\n11. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent.\n\n    Exclusion Criteria\n12. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 10 mg prednisone will be allowed\n13. Have leptomeningeal spread.\n14. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.\n15. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.\n16. Previous exposure to Crizanlizumab or any other P-selectin inhibitor.\n17. Previous or current brain hemorrhage.\n18. The patient had, or is expected to undergo, allogeneic hematopoietic stem cell transplantation (HSCT).\n19. The patient had a contraindication for undergoing brain MRI.\n20. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n21. Pregnant or lactating\n22. Treatment with other investigational drugs within \\\u003C21 days of start of day 1 of the study treatment.\n23. Any contraindication for treatment with nivolumab according to the product's labels.\n\nCohort 2 (Recurrent or Progressive GB) Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Estimated life expectancy at least 3 months\n3. Have with recurrent or persistent GB\n4. Received first line therapy with brain irradiation and maintenance temozolamide.\n5. Measurable disease per RANO criteria on brain MRI.\n6. Have Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2.\n7. Adequate organ function defined by blood tests for blood count and chemistry.\n8. Women of childbearing potential practicing an acceptable method of birth control.\n9. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent.\n\nExclusion Criteria\n\n1. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed\n2. Have leptomeningeal spread.\n3. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.\n4. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.\n5. Previous exposure to Crizanlizumab or any other P-selectin inhibitor.\n6. Previous or current brain hemorrhage.\n7. The patient had, or is expected to undergo, allogeneic HSCT.\n8. The patient had a contraindication for undergoing brain MRI.\n9. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n10. Pregnant or lactating\n11. Treatment with other investigational drugs within \\\u003C21 days of start of day 1 of the study treatment.\n12. Any contraindication for treatment with nivolumab according to the product's labels.\n\nCohort 3 (Newly Diagnosed Unmethylated GB) Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Estimated life expectancy at least 3 months.\n3. Histologically confirmed newly diagnosed GB.\n4. Tumor test result shows MGMT unmethylated type.\n5. Received definitive brain irradiation.\n6. Patients may be treated with novo TTF (optune) per local standard.\n7. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Adequate organ function defined by blood tests for blood count and chemistry.\n9. Women of childbearing potential practicing an acceptable method of birth control.\n10. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent.\n\nExclusion Criteria\n\n1. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed\n2. Have leptomeningeal spread.\n3. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.\n4. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.\n5. Previous exposure to Crizanlizumab or any other P-selectin inhibitor.\n6. Previous or current brain hemorrhage.\n7. The patient had, or is expected to undergo, allogeneic HSCT.\n8. The patient had a contraindication for undergoing brain MRI.\n9. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n10. Be pregnant or lactating\n11. Treatment with other investigational drugs within \\\u003C21 days of start of day 1 of the study treatment.\n\nAny contraindication for treatment with nivolumab according to the product's labels","ALL","18 Years",{"count":88,"type":89},33,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","A single-center, open-label, non-randomized phase I\u002FII study to evaluate the efficacy, safety and tolerance of crizanlizumab monotherapy and in combination with nivolumab in patients with advanced glioblastoma (GB) who exhausted standard of care (SOC) therapy, patients with metastatic brain melanoma (MBM) and patients with newly diagnosed unmethylated GB.\n\nSubjects will be screened for up to 28 days prior to treatment initiation. Eligible subjects will be allocated to one of 3 cohorts:\n\nCohort 1: Patients with metastatic melanoma with primarily diagnosed or newly progressing brain metastases who failed immunotherapy.\n\nCohort 2: Patients with recurrent or progressing GB following primary radiation therapy and temozolomide. Patients may have failed up to 2 prior systemic treatment lines (including temozolomide as adjuvant therapy) and are candidates for further treatment.\n\nCohort 3: Patients with newly diagnosed GB who were evaluated for methylguanine-DNA methyltransferase(MGMT) methylation status and have un-methylated MGMT promotor-therefore, they are not candidates for maintenance temozolomide therapy.",[95,96,97],"Advanced Glioblastoma","Metastatic Melanoma in the Central Nervous System","MGMT-Unmethylated Glioblastoma","2025-07-17",{"date":100,"type":101},"2025-07-22","ACTUAL",{"date":103,"type":101},"2023-07-11",{"date":105,"type":89},"2030-07-30",{"name":5,"class":6},1]