A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
- Registration Number
- NCT00289627
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Inclusion Criteria
- Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ipilimumab (MDX-010, BMS-734016) ipilimumab (MDX-010, BMS-734016) -
- Primary Outcome Measures
Name Time Method Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
- Secondary Outcome Measures
Name Time Method estimate disease control rate estimate progression free survival rate at Week 12 estimate PFS estimate overall survival estimate survival rate at one year estimate duration of BOR evaluate proportion of patients whose duration of response is >=24 weeks estimate time to BOR evaluate safety profile of ipilimumab during the induction and maintenance phases evaluate health-related quality of life obtain PK sample for population PK analysis
Trial Locations
- Locations (1)
Local Institution
🇺🇦Uzhgorod, Ukraine