An Exploratory Study to Determine Potential Predictive Markers of Response and/or Toxicity in Patients With Unresectable Stage III or IV Malignant Melanoma Randomized and Treated With Ipilimumab (MDX-010/BMS-734016) at Two Dose Levels
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Unresectable Stage III or IV Malignant Melanoma
Both
Unresectable Stage III or IV Malignant Melanoma
Trial Information
An Exploratory Study to Determine Potential Predictive Markers of Response and/or Toxicity in Patients With Unresectable Stage III or IV Malignant Melanoma Randomized and Treated With Ipilimumab (MDX-010/BMS-734016) at Two Dose Levels
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)
Outcome Time Frame:
on a continuous & ongoing basis
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA184-004
NCT ID:
NCT00261365
Start Date:
November 2005
Completion Date:
October 2007
Related Keywords:
- Unresectable Stage III or IV Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Comprehensive Cancer Center | Glendale, California 91204 |
| The Angeles Clinic And Research Institution | Santa Monica, California 90404 |
