An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

Inclusion Criteria

• Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
• Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
• Must have disease free status as determined by imaging within 4 weeks of dosing
• Tumor tissue must be provided for biomarker analysis
• Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria

• Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
• Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
• Subjects with active, known or suspected autoimmune disease
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
• Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
• Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection