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The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | 0.1 mg/kg every 3 weeks |
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| Arm 2 | Active Comparator | 1 mg/kg every 3 weeks |
|
| Arm 3 | Active Comparator | 1 mg/kg every 6 weeks |
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| Arm 4 | Active Comparator | 5 mg/kg every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD137 (4-1BB) (BMS-663513) | Drug | IV solution, IV, until PD or toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate | every 6 weeks starting at week 12 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profiles | throughout the study | |
| Disease response rate | end of study | |
| Disease control rate |
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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 Angeles Clinic & Research Institute | Los Angeles | California | 90025 | United States | ||
| Yale University School Of Medicine |
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| end of study |
| 1-year survival | end of study |
| Pharmacokinetics | throughout the study |
| Pharmacodynamics | throughout the study |
| Biomarkers | throughout the study |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Oncology Specialists, S.C. | Park Ridge | Illinois | 60068 | United States |
| Indiana University Melvin And Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Harry & Jeanette Weinberg Cancer Inst At Franklin Square | Baltimore | Maryland | 21237 | United States |
| Dana-Farber Cancer Inst | Boston | Massachusetts | 02115 | United States |
| Mem Sloan-Ket Can Ctr | New York | New York | 10021 | United States |
| Blumenthal Cancer Center, Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| University Of Texas | Houston | Texas | 77030 | United States |
| Local Institution | Calgary | Alberta | T2N 4N2 | Canada |
| Local Institution | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution | Montreal | Quebec | H4J 1C5 | Canada |
| Local Institution | Aarhus C | 8000 | Denmark |
| Local Institution | Odense C | DK-5000 | Denmark |
| Local Institution | Lille | 59037 | France |
| Local Institution | Paris | 75010 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Villejuif | 94805 | France |
| Local Institution | Homburg / Saar | 66421 | Germany |
| Local Institution | Jena | 07740 | Germany |
| Local Institution | Kiel | 24105 | Germany |
| Local Institution | Mainz | 55131 | Germany |
| Local Institution | Mannheim | 68167 | Germany |
| Local Institution | Tübingen | 72076 | Germany |
| Local Institution | Würzburg | 97080 | Germany |
| Local Institution | Genove | 16132 | Italy |
| Local Institution | Milan | 20141 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Siena | 53100 | Italy |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000620833 | urelumab |
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