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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]) | Clinical Trials | Clareo Health

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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])

Survival in Adult Patients With BRAF V600 Mutation-Positive Advanced Melanoma: A Non-Interventional Ambispective Study of a Cohort of Patients Treated With Cobimetinib During the French Early Access Program (TAU)

NCT03139513•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (33)

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

Key Dates

Start Date

October 27, 2016

Primary Completion Date

August 22, 2018

Completion Date

August 22, 2018

Last Updated

January 22, 2019

Enrollment

200

ESTIMATED participants

Conditions

Melanoma

Interventions

Cobimetinib

DRUG

Vemurafenib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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])

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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