[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vinblastine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vinblastine":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100589912","phase-3-perioperative-durvalumab-with-neoadjuvant-ddmvac-or-gemcitabinecisplatin-in-patients-with-muscle-invasive-bladder-cancer-niagara-2-100589912",false,"NCT06960577","Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine\u002FCisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem\u002FCis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","Inclusion Criteria:\n\n* Participants with clinical tumour stage T2-T4aN0\u002F1M0 or T1N1M0 with transitional or mixed transitional cell histology\n* Patients must be planning to undergo radical cystectomy\n* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer\n* ECOG performance status of 0 or 1\n* Minimum life expectancy of 12 weeks at first dose of study medication\n\nExclusion criteria:\n\n* Evidence of lymph node (N2-N3) or metastatic (M1) disease\n* Inoperable tumour(s) with fixation to the pelvic wall on clinical examination\n* Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem\u002Fcis).\n* Uncontrolled intercurrent illness.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine\u002Fcisplatin) in a clinical practice setting.",[26,27,28,29,30,31,32],"Urinary Bladder Neoplasms","Immune Checkpoint Inhibitors","Methotrexate","Vinblastine","Doxorubicin","Cisplatin","Gemcitabine",[34,35,36,37,38,39,32,31],"Muscle-invasive Bladder Cancer","Bladder Cancer","Immunotherapy","Durvalumab","Perioperative Durvalumab","ddMVAC","RECRUITING","2026-06-10",{"date":43,"type":44},"2026-06-11","ACTUAL",{"date":46,"type":44},"2025-05-15",{"date":48,"type":20},"2028-10-31",{"name":50,"class":51},"AstraZeneca","INDUSTRY",59]