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The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Active |
|
| 2 | Experimental | Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663513 | Drug | mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers | end of study | |
| Describe anti-tumor activity | throughout the study | |
| Obtain blood and plasma for exploratory research |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cancer Institute Of New Jersey | New Brunswick | New Jersey | 08901 | United States | ||
| Nyu Clinical Cancer Center |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000620833 | urelumab |
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| several timepoints throughout the study |
| Obtain archival tissue for predictive marker research | at screening |
| New York |
| New York |
| 10016 |
| United States |
| Thomas Jefferson Univ Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| University Of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |