A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT00289627
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ipilimumab (MDX-010, BMS-734016) — DRUGIV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Study Details
The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
Key Dates
- Start date
- Apr 30, 2006
- Status verified
- Sep 2016
- Primary completion
- Jul 31, 2007
- Completion
- Jul 31, 2007
Study Design
- Enrollment
- 155 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ipilimumab (MDX-010, BMS-734016)
Primary Outcome Measure
Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Little Rock | Arkansas | - | - |
| - | San Francisco | California | - | - |
| - | Santa Monica | California | - | - |
| - | Chicago | Illinois | - | - |
| - | Park Ridge | Illinois | - | - |
| - | Goshen | Indiana | - | - |
| - | Hazard | Kentucky | - | - |
| - | Albuquerque | New Mexico | - | - |
| - | New York | New York | - | - |
| - | Portland | Oregon | - | - |
| - | Greenville | South Carolina | - | - |
| - | Knoxville | Tennessee | - | - |
| - | Dallas | Texas | - | - |
| - | Charlottesvillle | Virginia | - | - |
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