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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Unresectable Stage III or IV Malignant Melanoma

Treatments: Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00261365

CA184-004

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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80 participants in 2 patient groups

A1

Active Comparator group

Treatment:

Drug: Ipilimumab

Drug: Ipilimumab

A2

Active Comparator group

Treatment:

Drug: Ipilimumab

Drug: Ipilimumab