Melanoma
Conditions
Keywords
Previously treated melanoma, Unresectable Stage III, Stage IV
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.
Interventions
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Sponsors
Medarex
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| estimate overall survival | — |
| obtain PK sample for population PK analysis | — |
| estimate disease control rate | — |
| estimate progression free survival rate at Week 12 | — |
| estimate PFS | — |
| evaluate health-related quality of life | — |
Countries
Austria, Finland, Italy, Norway, Poland, Russia, Spain, Sweden, Ukraine, United States
Outcome results
None listed