Melanoma
Conditions
Keywords
Stage III (unresectable), Stage IV melanoma
Brief summary
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.
Interventions
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
DRUGIpilimumab
IV solution, IV, 3 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
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. | — |
Secondary
| Measure | Time frame |
|---|---|
| estimate disease control rate at various time points | — |
| estimate overall survival | — |
| estimate progression free survival rate at Week 12 assessment and other timepoints | — |
| evaluate health-related quality of life | — |
| obtain pharmacokinetic samples for population PK analysis | — |
| estimate survival rate at one year | — |
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, South Africa, United States
Outcome results
None listed