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

Bristol-Myers Squibb80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Unresectable Stage III or IV Malignant Melanoma

Interventions

IpilimumabDRUG

Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

IpilimumabDRUG

Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

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

Outcomes

Primary Outcomes

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

Time frame: on a continuous & ongoing basis

Secondary Outcomes

Safety & tumor response are important secondary objectives. Safety evaluated

Time frame: on a continuous & ongoing basis

Tumor response measured

Time frame: starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months

Data from ClinicalTrials.gov

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