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The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Drug | Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016) | on a continuous & ongoing basis |
| Measure | Description | Time Frame |
|---|---|---|
| Safety & tumor response are important secondary objectives. Safety evaluated | on a continuous & ongoing basis | |
| Tumor response measured | starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months |
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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 |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center | Palm Springs | California | 92262 | United States | ||
| The Angeles Clinic And Research Institution |
| 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. | |
| 22123319 |
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| Ipilimumab | Drug | Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response. |
|
|
| Santa Monica |
| California |
| 90404 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Local Institution | Aarhus C | 8000 | Denmark |
| Local Institution | Odense C | 5000 | Denmark |
| Local Institution | Jerusalem | 72080 | Israel |
| Local Institution | Bari | 70126 | Italy |
| Local Institution | Forlì | 47100 | Italy |
| Local Institution | Ravenna | 48100 | Italy |
| Local Institution | Rimini | 47900 | Italy |
| Local Institution | Oslo | 0310 | Norway |
| Local Institution | Lima | Lima Province | 43 | Peru |
| Local Institution | Lima | Lima Province | LIMA 11 | Peru |
| Local Institution | Gothenberg | 413 45 | Sweden |
| Local Institution | Stockholm | 171 76 | Sweden |
| Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204. |
| 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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