|Exclusion Criteria:||1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.|
2) Women who are pregnant or breastfeeding.
3) Women with a positive pregnancy test on enrollment or prior to study drug administration.
4) Sexually active fertile men whose partners are woman of child bearing potential, unless using an adequate method of birth control.
5) Prior treatment with an anti-CTLA4 antibody.
6) Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix.
7) Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]).
8) Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
9) Positive screening tests for or any prior history of Active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
10) Patients who are deemed ineligible for surgery after standard of care evaluation for medical comorbidities.
11) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab).
12) Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses).
13) Previous participation in another ipilimumab clinical trial or prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist.
14) Treatment with other investigational products within the last 4 weeks prior to randomization into this study.
15) Prior radiation therapy for urothelial carcinoma.
16) Prior systemic chemotherapy for urothelial carcinoma.
17) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.