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The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-936559 (1mg/kg) | Experimental |
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| Arm 2: BMS-936559 (3mg/kg) | Experimental |
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| Arm 3: BMS-936559 (10mg/kg) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-936559 (Anti-PD-L1) | Biological | Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response |
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| Measure | Description | Time Frame |
|---|---|---|
| Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry | Baseline and within the first 24 weeks of study participation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs | Every 2 weeks until 70 days after last treatment | |
| Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| ID | Term |
|---|---|
| C000627113 | BMS-936559 |
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| BMS-936559 (Anti-PD-L1) | Biological | Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response |
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| BMS-936559 (Anti-PD-L1) | Biological | Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response |
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| Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression |
| Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline | Baseline, Week 6, Week 12, and then every 12 weeks until follow-up |
| Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only | Predose (screening) and Cycle 3 Day 1 |