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This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice) |
|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dacarbazine | Drug | decarbazine 1000 mg/m2 IV Q 21 days x 12 |
| |
| CP-675,206 |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | August 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | 1 year | |
| PFS at 6 months | 6 months | |
| objective tumor response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntsville | Alabama | 35805 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30227886 | Derived | Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9. | |
| 23295794 |
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| Drug |
CP-675,206 15 mg/kg IV Q 90 days x 4 |
|
|
| temozolomide | Drug | temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12 |
|
| 1 year |
| Durable response | 6 months |
| pharmacokinetics endpoints | 15 months |
| pharmacogenomic endpoints | 1 year |
| HQol | 1 year |
| healthcare resource utilization and loss of productivity | 1 year |
| human antihuman antibody response for patients in Arm A | 15 months |
| Mobile |
| Alabama |
| 36607 |
| United States |
| Research Site | Scottsdale | Arizona | 85260 | United States |
| Research Site | Little Rock | Arkansas | 72205 | United States |
| Research Site | Bakersfield | California | 93309 | United States |
| Research Site | Corona | California | 92879 | United States |
| Research Site | Fullerton | California | 92835 | United States |
| Research Site | Glendora | California | 91741 | United States |
| Research Site | Huntington Beach | California | 92648 | United States |
| Research Site | Long Beach | California | 90813 | United States |
| Research Site | Los Alamitos | California | 90720 | United States |
| Research Site | Los Angeles | California | 90095-6970 | United States |
| Research Site | Los Angeles | California | 90095 | United States |
| Research Site | Oxnard | California | 93030 | United States |
| Research Site | Pasadena | California | 91105 | United States |
| Research Site | Pomona | California | 91767 | United States |
| Research Site | Rancho Cucamonga | California | 91730 | United States |
| Research Site | Santa Barbara | California | 93105 | United States |
| Research Site | Santa Maria | California | 93454 | United States |
| Research Site | West Covina | California | 91790 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Stamford | Connecticut | 06902-3628 | United States |
| Research Site | Boynton Beach | Florida | 33426 | United States |
| Research Site | Lake Worth | Florida | 33461-4710 | United States |
| Research Site | Zion | Illinois | 60099 | United States |
| Research Site | Beech Grove | Indiana | 46107 | United States |
| Research Site | Indianapolis | Indiana | 46237 | United States |
| Research Site | Indianapolis | Indiana | 46260 | United States |
| Research Site | Baltimore | Maryland | 21237-3998 | United States |
| Research Site | City of Saint Peters | Missouri | 63376 | United States |
| Research Site | Creve Coeur | Missouri | 63141 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Omaha | Nebraska | 68114 | United States |
| Research Site | Henderson | Nevada | 89015 | United States |
| Research Site | Henderson | Nevada | 89052 | United States |
| Research Site | Las Vegas | Nevada | 89109 | United States |
| Research Site | Las Vegas | Nevada | 89128 | United States |
| Research Site | Las Vegas | Nevada | 89135 | United States |
| Research Site | Las Vegas | Nevada | 89148 | United States |
| Research Site | Morristown | New Jersey | 07962 | United States |
| Research Site | Albany | New York | 12206 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Chapel Hill | North Carolina | 27599-7600 | United States |
| Research Site | Charlotte | North Carolina | 28203 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Canton | Ohio | 44718 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Dover | Ohio | 44718 | United States |
| Research Site | Bethlehem | Pennsylvania | 18015 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Salt Lake City | Utah | 84112 | United States |
| Research Site | Federal Way | Washington | 98003 | United States |
| Research Site | Lakewood | Washington | 98499 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Ciudad de Buenos Aires | Buenos Aires | C1280AEA | Argentina |
| Research Site | Waratah | New South Wales | 2300 | Australia |
| Research Site | Westmead | New South Wales | 2145 | Australia |
| Research Site | Woolloongabba | Queensland | 4102 | Australia |
| Research Site | Adelaide | South Australia | 5000 | Australia |
| Research Site | Launceston | Tasmania | 7250 | Australia |
| Research Site | East Melbourne | Victoria | 3002 | Australia |
| Research Site | Vienna | A-1090 | Austria |
| Research Site | Brussels | 1090 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Namur | 5000 | Belgium |
| Research Site | Roeselare | 8800 | Belgium |
| Research Site | Turnhout | 2300 | Belgium |
| Research Site | Wilrijk | 2610 | Belgium |
| Research Site | Yvoir | 5530 | Belgium |
| Research Site | Calgary | Alberta | T2N 4N2 | Canada |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Victoria | British Columbia | V8R 6V5 | Canada |
| Research Site | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Research Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Research Site | London | Ontario | N6A 4L6 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Windsor | Ontario | N8W 1L9 | Canada |
| Research Site | Windsor | Ontario | N8W 2X3 | Canada |
| Research Site | Montreal | Quebec | H2L 4M1 | Canada |
| Research Site | Québec | Quebec | G1R 2J6 | Canada |
| Research Site | Montpellier | Cedex 05 | 34280 | France |
| Research Site | Besançon | 25030 | France |
| Research Site | Bordeaux | 33075 | France |
| Research Site | Boulogne | 92104 | France |
| Research Site | Caen | 14033 | France |
| Research Site | Lille | 59000 | France |
| Research Site | Marseille | 13009 | France |
| Research Site | Nantes | 44035 | France |
| Research Site | Paris | 75010 | France |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Frankfurt | 60488 | Germany |
| Research Site | Hanover | 30449 | Germany |
| Research Site | Kiel | 24105 | Germany |
| Research Site | Tübingen | 72076 | Germany |
| Research Site | Athens | 115 27 | Greece |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Tel Aviv | 64239 | Israel |
| Research Site | Tel Litwinsky | 52621 | Israel |
| Research Site | Genova | 16132 | Italy |
| Research Site | Milan | 20141 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Roma | 00144 | Italy |
| Research Site | Siena | 53100 | Italy |
| Research Site | Mexico City | Mexico City | 06720 | Mexico |
| Research Site | Mexico City | Mexico City | 14080 | Mexico |
| Research Site | Amsterdam | North Holland | 1066 CX | Netherlands |
| Research Site | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
| Research Site | Leiden | South Holland | 2311 JS | Netherlands |
| Research Site | Nijmegen | 6525 GA | Netherlands |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Krakow | 31-115 | Poland |
| Research Site | Lubin | 59-300 | Poland |
| Research Site | Poznan | 61-866 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Obninsk | Kaluga Oblast | 249036 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Bratislava | 833 10 | Slovakia |
| Research Site | Cape Town | 7500 | South Africa |
| Research Site | Pretoria | 0181 | South Africa |
| Research Site | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Research Site | Barcelona | Barcelona | 08036 | Spain |
| Research Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Research Site | Santander | Cantabria | 39008 | Spain |
| Research Site | Madrid | Madrid | 28041 | Spain |
| Research Site | Pamplona | Navarre | 31008 | Spain |
| Research Site | Oviedo | Principality of Asturias | 33006 | Spain |
| Research Site | Zaragoza | Zaragoza | 50009 | Spain |
| Research Site | Gothenburg | 413 45 | Sweden |
| Research Site | Lund | 221 85 | Sweden |
| Research Site | Zurich | 8091 | Switzerland |
| Research Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Research Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Research Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| Research Site | London | SW3 6JJ | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| Research Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Research Site | Wolverhampton | WV10 0QP | United Kingdom |
| Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7. |
| 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 |
|---|---|
| D003606 | Dacarbazine |
| C520704 | tremelimumab |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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