Brief Title: 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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Disease free survival (DFS)

Primary Outcome 1 - Timeframe: Approximately 5 years after the first subject is randomized

CONDITION

• Various Advanced Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: N/A

Email: Clinical.Trials@bms.com

LOCATION