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)

January 18, 2019 updated by: Hoffmann-La Roche

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)

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®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi Cedex 9, France, 81013
        • Centre hospitalier d'Albi
      • Antony, France, 92166
        • Hopital Prive D Antony; Dermatologie
      • Bayonne, France, 64109
        • Chic Cote Basque Bayonne; Medecine II
      • Besançon Cedex, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
      • Bobigny, France, 93009
        • Hopital Avicenne; Dermatologie
      • Bourg en Bresse, France, 01000
        • Ch Fleyriat
      • CHAMBERY Cedex, France, 73011
        • CH Metropole de Savoie
      • Clermont Ferrand, France, 63003
        • Chu Estaing; Dermatologie
      • Colmar, France, 68024
        • Hopital Louis Pasteur; Sce Dermatologie
      • Dijon, France, 21000
        • Centre Georges Francois Leclerc
      • Dijon, France, 21079
        • Chu Site Du Bocage;Dermatologie
      • Le Mans, France, 72037
        • Centre Hospitalier Le Mans; Dermatologie
      • Lille, France, 59037
        • Hopital Claude Huriez; Sce Dermatologie
      • Limoges, France, 87042
        • CHU de Limoges - Hôpital Dupuytren
      • Marseille, France, 13385
        • Hopital Timone Adultes; Dermatologie
      • Montivilliers, France, 76290
        • Hopital Jacques Monod; Dermatologie
      • Montpellier, France, 34295
        • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
      • Mulhouse, France, 68070
        • CH de Mulhouse Hôpital Emile Muller
      • Nice cedex 3, France, 06200
        • Hopital l Archet 2; Ginestriere, Service de; Dermatologie
      • Paris, France, 75018
        • Groupe Hospitalier Bichat Claude Bernard
      • Paris, France, 75006
        • Hopital Cochin; Dermatologie
      • Pringy, France
        • CENTRE HOSPITALIER ANNECY-GENEVOIS; Dematologie
      • Rennes, France, 35000
        • Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer
      • Rouen, France, 76031
        • CHU Rouen - CH C. Nicolle - Clinique dermatologique
      • Saint Etienne, France, 42055
        • CHU de Saint-Etienne - Hôpital Nord
      • Saint Germain, France, 07810
        • CHI de Poissy St Germain
      • St Malo Cedex, France, 35403
        • Hôpital Broussais
      • Strasbourg, France, 67000
        • Pole de Cancerologie Prive Strasbourgeois
      • Thionville Cedex, France, 57126
        • Hôpital Bel Air
      • Toulon, France, 83041
        • Hia Sainte Anne; Medecine Interne Oncologie
      • Toulouse, France, 31059
        • CHU de Toulouse - Hopital Larrey
      • Valence, France, 26953
        • Centre Hospitalier Valence
      • Villejuif, France, 94805
        • Institut Gustave Roussy; Dermatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with BRAF V600 mutation-positive advanced melanoma treated with cobimetinib during the French early access program (TAU).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Cobimetinib
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
Other Names:
  • Cotellic®
Drug: Vemurafenib
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
Other Names:
  • Zelboraf®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Percentage of Participants with Complete Response (CR) or Partial Response (PR) to Treatment According to RECIST as Assessed by Physician
Time Frame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Time to Cobimetinib Treatment Discontinuation
Time Frame: From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
Percentage of Participants by Treatments After Disease Progression or Permanent Cobimetinib Treatment Discontinuation
Time Frame: From disease progression or permanent cobimetinib treatment discontinuation up to overall study completion (assessed up to 18 months)
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)
Time Frame: 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.
From first intake of cobimetinib up to inclusion in the study (up to Day 1)
Prospective Period: Percentage of Participants with Adverse Events (AEs)
Time Frame: From first intake of cobimetinib up to overall study completion (assessed up to 18 months)
From first intake of cobimetinib up to overall study completion (assessed up to 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2016

Primary Completion (Actual)

August 22, 2018

Study Completion (Actual)

August 22, 2018

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29964

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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