Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection
Part of paid clinical trials in Houston, Texas.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT00362713
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab — DRUGIntravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24
Study Details
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.
Key Dates
- Start date
- Mar 31, 2007
- Status verified
- Dec 2009
- Primary completion
- Oct 31, 2009
- Completion
- Oct 31, 2009
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: A3 mg/kg or 10 mg/kg
Primary Outcome Measure
Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population. [ Time Frame: assessed throughout the study ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University Of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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