A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

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)