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])
NCT ID: NCT03139513
Last Updated: 2019-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2016-10-27
2018-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Metastatic Melanoma
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.
Cobimetinib
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
Vemurafenib
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
Interventions
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Cobimetinib
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
Vemurafenib
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
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, , 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, , France
Pole de Cancerologie Prive Strasbourgeois
Strasbourg, , France
Hopital Bel Air
Thionville, , 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
Countries
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Other Identifiers
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ML29964
Identifier Type: -
Identifier Source: org_study_id
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