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]) (MELANIS)

Roche

Status: Completed

Conditions: Melanoma

Treatments: Drug: Cobimetinib; Drug: Vemurafenib

Study type: Observational

Funder types: Industry

Identifiers

NCT03139513

ML29964

Details and patient eligibility

About

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®).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Metastatic Melanoma

Description:

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.

Treatment:

Drug: Vemurafenib

Drug: Cobimetinib