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| Name | Class |
|---|---|
| Medarex | INDUSTRY |
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipilimumab (MDX-010, BMS-734016) | Drug | IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| estimate progression free survival rate at Week 12 assessment and other timepoints | ||
| estimate disease control rate at various time points | ||
| estimate overall survival |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| Wilshire Oncology Medical Group Inc |
| 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. | |
| 20004617 |
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| Ipilimumab | Drug | IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response. |
|
| Ipilimumab | Drug | IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response. |
|
| estimate survival rate at one year |
| evaluate health-related quality of life |
| obtain pharmacokinetic samples for population PK analysis |
| Laverne |
| California |
| 91750 |
| United States |
| Scripps Cancer Center | San Diego | California | 92121 | United States |
| The Angeles Clinic And Research Institution | Santa Monica | California | 90404 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Md Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Oncology Specialists, Sc | Park Ridge | Illinois | 60068 | United States |
| American Health Network | Indianapolis | Indiana | 46202 | United States |
| University Of Louisville | Louisville | Kentucky | 40202 | United States |
| Harry And Jeanette Weinberg Cancer Inst At Franklin Square | Baltimore | Maryland | 21237 | United States |
| Hubert H. Humphrey Cancer Center | Robbinsdale | Minnesota | 55422 | United States |
| Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | United States |
| St Joseph Oncology Inc | Saint Joseph | Missouri | 64507 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28204 | United States |
| The Christ Hospital Cancer Center Research | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Cancer Centers Of The Carolinas | Greenville | South Carolina | 29615 | United States |
| Center For Oncology Research & Treatment, P.A. | Dallas | Texas | 75230 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75246 | United States |
| Local Institution | Newcastle | New South Wales | 2300 | Australia |
| Local Institution | Brisbane | Queensland | 4101 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Wodonga | Victoria | 3690 | Australia |
| Local Institution | Brussels | 1070 | Belgium |
| Local Institution | Brussels | 1090 | Belgium |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Centro-Porto Alegre | Rio Grande do Sul | 90020 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90610 | Brazil |
| Local Institution | Jaú | São Paulo | 17210 | Brazil |
| Local Institution | São Paulo | São Paulo | 01509 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4N2 | Canada |
| Local Institution | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution | Kingston | Ontario | K7L 5P9 | Canada |
| Local Institution | Olomouc | 775 20 | Czechia |
| Local Institution | Prague | 128 08 | Czechia |
| Local Institution | Brest | Cedex | 29200 | France |
| Local Institution | Clermont-Ferrand | 63058 | France |
| Local Institution | Lyon | 69288 | France |
| Local Institution | Lyon | 69373 | France |
| Local Institution | Marseille | 13009 | France |
| Local Institution | Paris | 75010 | France |
| Local Institution | Rennes | 35042 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Berlin | 12200 | Germany |
| Local Institution | Essen | 45122 | Germany |
| Local Institution | Heidelberg | 69115 | Germany |
| Local Institution | Jena | 07740 | Germany |
| Local Institution | Kiel | 24105 | Germany |
| Local Institution | Mannheim | 68169 | Germany |
| Local Institution | Würzburg | 97080 | Germany |
| Local Institution | Pécs | 7624 | Hungary |
| Local Institution | Johannesburg | Gauteng | 2199 | South Africa |
| Local Institution | Pretoria | Gauteng | 0041 | South Africa |
| Local Institution | Pretoria | Gauteng | 0181 | South Africa |
| Local Institution | Cape Town | Western Cape | 7506 | South Africa |
| Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbe C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8. |
| 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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