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Brief Title: A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced Melanoma
Official Title: GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma
Study ID: NCT00942162
Brief Summary: The objective of this study is to evaluate the clinical activity of the GSK2132231A immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma presenting with the predictive gene signature.
Detailed Description: In this study, patients were to receive a maximum of 24 doses of recMAGE-A3 + AS15 according four cycles over a period of four years. An active follow-phase (up to five years after registration into the study) was planned for all patients. As of Amendment 2, there will no longer be an active follow-up of patients after discontinuation or completion of the treatment. The study will end approximately 30 days after the last dose will be administered. In addition, no more biological samples will be collected for protocol research purposes. For each biological sample already collected in the scope of this study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant. Blood sampling for safety monitoring as per protocol will continue.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Orange, California, United States
GSK Investigational Site, Orlando, Florida, United States
GSK Investigational Site, Stuart, Florida, United States
GSK Investigational Site, Tampa, Florida, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Ann Arbor, Michigan, United States
GSK Investigational Site, Saint Louis, Missouri, United States
GSK Investigational Site, Morristown, New Jersey, United States
GSK Investigational Site, Durham, North Carolina, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Dallas, Texas, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Seattle, Washington, United States
GSK Investigational Site, Besançon cedex, , France
GSK Investigational Site, Boulogne, , France
GSK Investigational Site, Brest, , France
GSK Investigational Site, Dijon, , France
GSK Investigational Site, Grenoble, , France
GSK Investigational Site, Marseille Cedex 5, , France
GSK Investigational Site, Montpellier, , France
GSK Investigational Site, Nantes, , France
GSK Investigational Site, Paris, , France
GSK Investigational Site, Paris, , France
GSK Investigational Site, Rouen, , France
GSK Investigational Site, Tours, , France
GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Mannheim, Baden-Wuerttemberg, Germany
GSK Investigational Site, Tuebingen, Baden-Wuerttemberg, Germany
GSK Investigational Site, Nuernberg, Bayern, Germany
GSK Investigational Site, Wuerzburg, Bayern, Germany
GSK Investigational Site, Marburg, Hessen, Germany
GSK Investigational Site, Wiesbaden, Hessen, Germany
GSK Investigational Site, Buxtehude, Niedersachsen, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Essen, Nordrhein-Westfalen, Germany
GSK Investigational Site, Koeln, Nordrhein-Westfalen, Germany
GSK Investigational Site, Muenster, Nordrhein-Westfalen, Germany
GSK Investigational Site, Ludwigshafen, Rheinland-Pfalz, Germany
GSK Investigational Site, Homburg, Saarland, Germany
GSK Investigational Site, Quedlinburg, Sachsen-Anhalt, Germany
GSK Investigational Site, Kiel, Schleswig-Holstein, Germany
GSK Investigational Site, Luebeck, Schleswig-Holstein, Germany
GSK Investigational Site, Erfurt, Thueringen, Germany
GSK Investigational Site, Jena, Thueringen, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Cork, , Ireland
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Galway, , Ireland
GSK Investigational Site, Napoli, Campania, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Siena, Toscana, Italy
GSK Investigational Site, Padova, Veneto, Italy
GSK Investigational Site, Kraków, , Poland
GSK Investigational Site, Olsztyn, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Warszawa, , Poland
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR