Urothelial Carcinoma
Conditions
Brief summary
The purpose of this study is to learn if ipilimumab can be given safely at two different doses given to patients with urothelial cancer who are going to have surgery as part of their treatment. The immunological effectiveness of ipilimumab will also be studied.
Interventions
DRUGIpilimumab
Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population. | assessed throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate anti-cancer immunological activity in blood and tissue samples compared to pre-treatment or control samples. | assessed throughout the study |
Countries
United States
Outcome results
None listed