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| Name | Class |
|---|---|
| Medarex | INDUSTRY |
The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ipilimumab (MDX-010, BMS-734016) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipilimumab (MDX-010, BMS-734016) | Drug | IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab. |
| Measure | Description | Time Frame |
|---|---|---|
| estimate disease control rate | ||
| estimate progression free survival rate at Week 12 | ||
| estimate PFS |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25667295 | Derived | Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9. | |
| 19139884 |
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| estimate overall survival |
| estimate survival rate at one year |
| estimate duration of BOR |
| evaluate proportion of patients whose duration of response is >=24 weeks |
| estimate time to BOR |
| evaluate safety profile of ipilimumab during the induction and maintenance phases |
| evaluate health-related quality of life |
| obtain PK sample for population PK analysis |
| San Francisco |
| California |
| United States |
| Santa Monica | California | United States |
| Chicago | Illinois | United States |
| Park Ridge | Illinois | United States |
| Goshen | Indiana | United States |
| Hazard | Kentucky | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Portland | Oregon | United States |
| Greenville | South Carolina | United States |
| Knoxville | Tennessee | United States |
| Dallas | Texas | United States |
| Charlottesvillle | Virginia | United States |
| Local Institution | Salzburg | Austria |
| Local Institution | Vienna | Austria |
| Local Institution | Wels | Austria |
| Local Institution | Turku | Finland |
| Local Institution | Genova | Italy |
| Local Institution | Meldola | Italy |
| Local Institution | Milan | Italy |
| Local Institution | Naples | Italy |
| Local Institution | Padova | Italy |
| Local Institution | Siena | Italy |
| Local Institution | Torino | Italy |
| Local Institution | Oslo | Norway |
| Local Institution | Lodz | Poland |
| Local Institution | Poznan | Poland |
| Local Institution | Wroclaw | Poland |
| Local Institution | Barnaul | Russia |
| Local Institution | Moscow | Russia |
| Local Institution | Murmansk | Russia |
| Local Institution | Ryazan | Russia |
| Local Institution | Saint Petersburg | Russia |
| Local Institution | Samara | Russia |
| Local Institution | Stavropol | Russia |
| Local Institution | Veliky Novgorod | Russia |
| Local Institution | Voronezh | Russia |
| Local Institution | Barcelona | Spain |
| Local Institution | Madrid | Spain |
| Local Institution | Málaga | Spain |
| Local Institution | Santa Cruz de Tenerife | Spain |
| Local Institution | Valencia | Spain |
| Local Institution | Gothenburg | Sweden |
| Local Institution | Lund | Sweden |
| Local Institution | Stockholm | Sweden |
| Local Institution | Uppsala | Sweden |
| Local Institution | Cherkassy | Ukraine |
| Local Institution | Dnipropetrovsk | Ukraine |
| Local Institution | Kiev | Ukraine |
| Local Institution | Lviv | Ukraine |
| Local Institution | Sumy | Ukraine |
| Local Institution | Uzhhorod | Ukraine |
| Di Giacomo AM, Danielli R, Guidoboni M, Calabro L, Carlucci D, Miracco C, Volterrani L, Mazzei MA, Biagioli M, Altomonte M, Maio M. Therapeutic efficacy of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases. Cancer Immunol Immunother. 2009 Aug;58(8):1297-306. doi: 10.1007/s00262-008-0642-y. Epub 2009 Jan 13. |
| 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 |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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