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])

Completed

• Conditions: Melanoma
• Interventions: Drug: Cobimetinib; Drug: Vemurafenib

• 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.

Study Timeline

• Study Start: 2016-10-27
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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)

Centre Hospitalier d'Albi; 🇫🇷 Albi Cedex 9, France

Hopital Prive D Antony; Dermatologie; 🇫🇷 Antony, France

Chic Cote Basque Bayonne; Medecine II; 🇫🇷 Bayonne, France

CHU Besançon - Hôpital Jean Minjoz; 🇫🇷 Besançon Cedex, France

Hopital Avicenne; Dermatologie; 🇫🇷 Bobigny, France

CH Fleyriat; 🇫🇷 Bourg en Bresse, France

CH Metropole de Savoie; 🇫🇷 CHAMBERY Cedex, France

Chu Estaing; Dermatologie; 🇫🇷 Clermont Ferrand, France

Hopital Louis Pasteur; Sce Dermatologie; 🇫🇷 Colmar, France

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

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