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 — DRUG
    Intravenous 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: A
    3 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)

FacilityCityStateZIPSite coordinators
The University Of Texas MD Anderson Cancer CenterHoustonTexas77030-

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