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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
Not Enrolling
Both
Unresectable Stage III or IV Malignant Melanoma

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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 CenterBoston, Massachusetts  02215
Comprehensive Cancer CenterGlendale, California  91204
The Angeles Clinic And Research InstitutionSanta Monica, California  90404