Unresectable Stage III or IV Malignant Melanoma
Conditions
Brief summary
The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
Interventions
DRUGIpilimumab
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016) | on a continuous & ongoing basis |
Secondary
| Measure | Time frame |
|---|---|
| Safety & tumor response are important secondary objectives. Safety evaluated | on a continuous & ongoing basis |
| Tumor response measured | starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months |
Countries
Denmark, Israel, Italy, Norway, Peru, Sweden, United States
Outcome results
None listed