First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

Inclusion Criteria

• •Histological or cytological proof of urothelial carcinoma of the urethra, bladder, ureters, or renal pelvis.
• •Advanced (clinical stage T4b, unresectable) or metastatic disease.
• •Prior radiation therapy is allowed to \< 25% of the bone marrow.
• •Age \> 18 years at the time of consent.
• •Written informed consent and HIPAA authorization for release of personal health information.
• •Females must not be pregnant or breastfeeding.
• •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.
• •Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study \[and for up to 26 weeks after the last dose of investigational product\] in such a manner that the risk of pregnancy is minimized.
• •Prior Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[eg, Wegener's Granulomatosis\]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with other immune disorders should not be enrolled without discussion with the principal investigator.