Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

Phase 1

Completed

• Conditions: Unresectable Stage III or IV Malignant Melanoma
• Interventions: Drug: Ipilimumab

• Registration Number: NCT00261365
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-01
• Study First Submitted QC: 2005-12-01
• Study First Posted: 2005-12-05
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-08
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A1	Ipilimumab	-
A2	Ipilimumab	-

Primary Outcome Measures

Name	Time	Method
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)	on a continuous & ongoing basis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Comprehensive Cancer Center; 🇺🇸 Palm Springs, California, United States

The Angeles Clinic And Research Institution; 🇺🇸 Santa Monica, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Local Institution; 🇸🇪 Stockholm, Sweden