Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection

Inclusion criteria

• Previously untreated urothelial cancer requiring surgery for treatment
• Ineligible for chemotherapy
• Adequate hematologic, kidney and liver function

Exclusion criteria

• Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment prior to study drug administration
• Prior treatment with ipilimumab or other anti-CTLA4 antibody, or a CD137 agonist
• Concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
• Autoimmune disease: subjects with a documented 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]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study
• Patients deemed ineligible for surgery
• Any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
• Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
• Prior radiation therapy for urothelial cancer
• Positive screening tests for or any prior history of HIV, Hepatitis B or Hepatitis C