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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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