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®).
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.
Study Type
OBSERVATIONAL
Enrollment
200
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
Overall Survival (OS)
Time frame: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Percentage of Participants with Complete Response (CR) or Partial Response (PR) to Treatment According to RECIST as Assessed by Physician
Time frame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Time to Cobimetinib Treatment Discontinuation
Time frame: From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
Percentage of Participants by Treatments After Disease Progression or Permanent Cobimetinib Treatment Discontinuation
Time frame: From disease progression or permanent cobimetinib treatment discontinuation up to overall study completion (assessed up to 18 months)
Retrospective Period: Percentage of Participants with Targeted Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with following targeted adverse events will be reported: fever (pyrexia), diarrhea, hepatic abnormalities, creatinine phosphokinapse (CPK) increased, rhabdomyolysis, retinal serous detachment, decrease in left ventricular ejection fraction (LVEF), squamous cell skin carcinoma and keratoacanthom, renal failure, drug reaction (or rash) with eosinophilia and systemic syndrome (DRESS), rash not otherwise specified (NOS), and photosensitivity.
Time frame: From first intake of cobimetinib up to inclusion in the study (up to Day 1)
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Centre Hospitalier d'Albi
Albi, France
Hopital Prive D Antony; Dermatologie
Antony, France
Chic Cote Basque Bayonne; Medecine II
Bayonne, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
Hopital Avicenne; Dermatologie
Bobigny, France
CH Fleyriat
Bourg-en-Bresse, France
CH Metropole de Savoie
Chambéry, France
Chu Estaing; Dermatologie
Clermont-Ferrand, France
Hopital Louis Pasteur; Sce Dermatologie
Colmar, France
Centre Georges Francois Leclerc
Dijon, France
...and 23 more locations
Prospective Period: Percentage of Participants with Adverse Events (AEs)
Time frame: From first intake of cobimetinib up to overall study completion (assessed up to 18 months)