Spots Global Cancer Trial Database for A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])
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Trial Identification
Brief Title: A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])
Official Title: Survival in Adult Patients With BRAF V600 Mutation-Positive Advanced Melanoma: A Non-Interventional Ambispective Study of a Cohort of Patients Treated With Cobimetinib During the French Early Access Program (TAU)
Study ID: NCT03139513
Conditions
Study Description
Brief Summary: This is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®).
Detailed Description: Concomitantly to the marketing authorization applications for cobimetinib and vemurafenib to European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2014, a French TAU program was initiated in February 2015. This study will enroll participants under this program.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier d'Albi, Albi Cedex 9, , France
Hopital Prive D Antony; Dermatologie, Antony, , France
Chic Cote Basque Bayonne; Medecine II, Bayonne, , France
CHU Besançon - Hôpital Jean Minjoz, Besançon Cedex, , France
Hopital Avicenne; Dermatologie, Bobigny, , France
CH Fleyriat, Bourg en Bresse, , France
CH Metropole de Savoie, CHAMBERY Cedex, , France
Chu Estaing; Dermatologie, Clermont Ferrand, , France
Hopital Louis Pasteur; Sce Dermatologie, Colmar, , France
Centre Georges Francois Leclerc, Dijon, , France
Chu Site Du Bocage;Dermatologie, Dijon, , France
Centre Hospitalier Le Mans; Dermatologie, Le Mans, , France
Hopital Claude Huriez; Sce Dermatologie, Lille, , France
CHU de Limoges - Hôpital Dupuytren, Limoges, , France
Hopital Timone Adultes; Dermatologie, Marseille, , France
Hopital Jacques Monod; Dermatologie, Montivilliers, , France
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie, Montpellier, , France
CH de Mulhouse Hôpital Emile Muller, Mulhouse, , France
Hopital l Archet 2; Ginestriere, Service de; Dermatologie, Nice cedex 3, , France
Hopital Cochin; Dermatologie, Paris, , France
Groupe Hospitalier Bichat Claude Bernard, Paris, , France
CENTRE HOSPITALIER ANNECY-GENEVOIS; Dematologie, Pringy, , France
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer, Rennes, , France
CHU Rouen - CH C. Nicolle - Clinique dermatologique, Rouen, , France
CHU de Saint-Etienne - Hopital Nord, Saint Etienne, , France
CHI de Poissy St Germain, Saint Germain, , France
Hopital Broussais, St Malo Cedex, , France
Pole de Cancerologie Prive Strasbourgeois, Strasbourg, , France
Hopital Bel Air, Thionville Cedex, , France
Hia Sainte Anne; Medecine Interne Oncologie, Toulon, , France
CHU de Toulouse - Hôpital Larrey, Toulouse, , France
Centre Hospitalier Valence, Valence, , France
Institut Gustave Roussy; Dermatologie, Villejuif, , France
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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