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