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
Active, Not Recruiting
