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

Bristol-Myers Squibb4 sites in 2 countries80 target enrollmentNovember 2005

InterventionsIpilimumab

Overview

Phase: Phase 1
Intervention: Ipilimumab
Conditions: Unresectable Stage III or IV Malignant Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 80
Locations: 4
Primary Endpoint: Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)
Status: Completed
Last Updated: 9 years ago

The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

October 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Sponsor

•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.

Intervention: Ipilimumab

Intervention: Ipilimumab

Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)

Time Frame: 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)
Safety & tumor response are important secondary objectives. Safety evaluated(on a continuous & ongoing basis)