Active, Not Recruiting
A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer - CA209-275
Updated: 6 July, 2020 | ClinicalTrials.gov
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Trial Details
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Active, Not Recruiting
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis - Measurable disease by CT or MRI - Progression or recurrence after treatment - i) With at least 1 platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or - ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer - Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases - Tumor tissues (archived or new biopsy) must be provided for biomarker analysis - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Subjects with active cancer that has spread to the central nervous system - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured - Subject with active, known or suspected autoimmune disease - Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration - Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways Exclusion laboratory criteria: - Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection - Known history of testing positive for human Immunodeficiency virus (HIV) or known acquired Immunodeficiency syndrome (AIDS)
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