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])
- Registration Number
- NCT03139513
- Lead Sponsor
- Hoffmann-La Roche
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Participants included in the TAU from 26 February 2015
- Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib
- For alive participants: participants who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control
- For participants who died before the inclusion period: participants who did not express their opposition when they were alive
- Alive participants unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Metastatic Melanoma Vemurafenib Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma, having started treatment with cobimetinib in combination with vemurafenib as per local guidelines and/or routine clinical practice in context of TAU program, will be observed. Metastatic Melanoma Cobimetinib Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma, having started treatment with cobimetinib in combination with vemurafenib as per local guidelines and/or routine clinical practice in context of TAU program, will be observed.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Complete Response (CR) or Partial Response (PR) to Treatment According to RECIST as Assessed by Physician From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months) Percentage of Participants by Treatments After Disease Progression or Permanent Cobimetinib Treatment Discontinuation 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) From first intake of cobimetinib up to inclusion in the study (up to Day 1) 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.
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months) Prospective Period: Percentage of Participants with Adverse Events (AEs) From first intake of cobimetinib up to overall study completion (assessed up to 18 months) Time to Cobimetinib Treatment Discontinuation From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
Trial Locations
- Locations (33)
CH Metropole de Savoie
🇫🇷CHAMBERY Cedex, France
Hopital Louis Pasteur; Sce Dermatologie
🇫🇷Colmar, France
Hopital Cochin; Dermatologie
🇫🇷Paris, France
Hopital Prive D Antony; Dermatologie
🇫🇷Antony, France
CH Fleyriat
🇫🇷Bourg en Bresse, France
Chu Site Du Bocage;Dermatologie
🇫🇷Dijon, France
CHU de Saint-Etienne - Hopital Nord
🇫🇷Saint Etienne, France
CHI de Poissy St Germain
🇫🇷Saint Germain, France
Pole de Cancerologie Prive Strasbourgeois
🇫🇷Strasbourg, France
Hopital Bel Air
🇫🇷Thionville Cedex, France
Centre Hospitalier d'Albi
🇫🇷Albi Cedex 9, France
Chic Cote Basque Bayonne; Medecine II
🇫🇷Bayonne, France
CHU Besançon - Hôpital Jean Minjoz
🇫🇷Besançon Cedex, France
Chu Estaing; Dermatologie
🇫🇷Clermont Ferrand, France
Centre Georges Francois Leclerc
🇫🇷Dijon, France
CHU de Limoges - Hôpital Dupuytren
🇫🇷Limoges, France
Hopital Jacques Monod; Dermatologie
🇫🇷Montivilliers, France
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
🇫🇷Montpellier, France
Groupe Hospitalier Bichat Claude Bernard
🇫🇷Paris, France
Hopital Avicenne; Dermatologie
🇫🇷Bobigny, France
Centre Hospitalier Le Mans; Dermatologie
🇫🇷Le Mans, France
Hopital Claude Huriez; Sce Dermatologie
🇫🇷Lille, France
Hopital Timone Adultes; Dermatologie
🇫🇷Marseille, France
CH de Mulhouse Hôpital Emile Muller
🇫🇷Mulhouse, France
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
🇫🇷Nice cedex 3, 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
Hopital Broussais
🇫🇷St Malo 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