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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])
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])

NCT03139513

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Melanoma

Interventions: Cobimetinib, Vemurafenib

Countries: France

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®).

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

\- Alive participants unable to give informed consent
Locations (33)
  • Albi, France
  • Antony, France
  • Bayonne, France
  • Besançon, France
  • Bobigny, France
  • Bourg-en-Bresse, France
  • Chambéry, France
  • Clermont-Ferrand, France
  • Colmar, France
  • Dijon, France
  • Dijon, France
  • Le Mans, France
  • Lille, France
  • Limoges, France
  • Marseille, France
  • Montivilliers, France
  • Montpellier, France
  • Mulhouse, France
  • Nice, France
  • Paris, France
  • Paris, France
  • Pringy, France
  • Rennes, France
  • Rouen, France
  • Saint-Etienne, France
  • Saint-Germain, France
  • St-Malo, France
  • Strasbourg, France
  • Thionville, France
  • Toulon, France
  • + 3 more on CT.gov