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| ID | Type | Description | Link |
|---|---|---|---|
| CA214-001 | Other Identifier | BMS |
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To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDX 1411 | Experimental | Dose Escalation Cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDX 1411 | Biological | MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety profile of MDX 1411 | duration of study | |
| Determine the maximum tolerated dose of MDX 1411 | duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the best overall response rate (BORR) | Day 38-42 of each cycle |
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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 |
|---|---|---|---|---|---|---|
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Barbara Ann Karmanos Cancer Institute |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Detroit |
| Michigan |
| 48201 |
| United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10466 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |