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This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663513 | Drug | mg/kg, intravenous (IV), 0.3, 1, 3, 6, 10 or 15 mg/kg, once every 3 weeks (q 3 wks), 12 weeks depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess Safety (Number and distribution and severity adverse events) of subjects | Active treatment of a minimum of 3 months up until disease progression or toxicity; and long-term follow-up to assess time to progression or death will conclude 2 years after the last treatment with BMS-663513. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy by evaluation of tumor response | At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug | |
| Assess pharmacokinetic parameters deriving from serum concentration versus time data | Cycle 1 Day 1, Cycle 2 Day 1 and 28, Cycle 3 Day 1 and 8, and Day 1 of every cycle the subject is on study from Cycle 4 and greater; and at study discharge. |
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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 |
|---|---|---|---|---|---|---|
| City Of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Yale University School Of Medicine |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000620833 | urelumab |
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| Assess pharmacodynamic and immune response analysis | up to 60 days after last dose of study drug |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution | Bordeaux | 33076 | France |
| Local Institution | Paris | 75004 | France |
| Local Institution | Paris | 75908 | France |
| Local Institution | Saint-Herblain | 44805 | France |
| Local Institution | Villejuif | 94800 | France |