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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1b Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy in Patients With Urothelial Carcinoma Undergoing Surgical Resection

Conditions
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Urothelial Carcinoma

Intervention / Treatment
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* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>3 mg/kg or 10 mg/kg | Drug: Ipilimumab<br>* Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24<br>* Other names: MDX-010;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population. |  | assessed throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate anti-cancer immunological activity in blood and tissue samples compared to pre-treatment or control samples. |  | assessed throughout the study |