A Phase 1b Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy 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