Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Previously untreated urothelial cancer requiring surgery for treatment
Ineligible for chemotherapy
Adequate hematologic, kidney and liver function
You may not be if
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
