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
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)
1 other identifier
observational
200
1 country
33
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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2016
CompletedFirst Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2018
CompletedJanuary 22, 2019
January 1, 2019
1.8 years
May 2, 2017
January 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
Secondary Outcomes (6)
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)
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)
Time to Cobimetinib Treatment Discontinuation
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
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)
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
Eligibility Criteria
Participants with BRAF V600 mutation-positive advanced melanoma treated with cobimetinib during the French early access program (TAU).
You may qualify if:
- 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
You may not qualify if:
- \- Alive participants unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Centre Hospitalier d'Albi
Albi, 81013, France
Hopital Prive D Antony; Dermatologie
Antony, 92166, France
Chic Cote Basque Bayonne; Medecine II
Bayonne, 64109, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
Hopital Avicenne; Dermatologie
Bobigny, 93009, France
CH Fleyriat
Bourg-en-Bresse, 01000, France
CH Metropole de Savoie
Chambéry, 73011, France
Chu Estaing; Dermatologie
Clermont-Ferrand, 63003, France
Hopital Louis Pasteur; Sce Dermatologie
Colmar, 68024, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Chu Site Du Bocage;Dermatologie
Dijon, 21079, France
Centre Hospitalier Le Mans; Dermatologie
Le Mans, 72037, France
Hopital Claude Huriez; Sce Dermatologie
Lille, 59037, France
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042, France
Hopital Timone Adultes; Dermatologie
Marseille, 13385, France
Hopital Jacques Monod; Dermatologie
Montivilliers, 76290, France
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
Montpellier, 34295, France
CH de Mulhouse Hôpital Emile Muller
Mulhouse, 68070, France
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
Nice, 06200, France
Hopital Cochin; Dermatologie
Paris, 75006, France
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018, France
CENTRE HOSPITALIER ANNECY-GENEVOIS; Dematologie
Pringy, France
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer
Rennes, 35000, France
CHU Rouen - CH C. Nicolle - Clinique dermatologique
Rouen, 76031, France
CHU de Saint-Etienne - Hopital Nord
Saint-Etienne, 42055, France
CHI de Poissy St Germain
Saint-Germain, 07810, France
Hopital Broussais
St-Malo, 35403, France
Pole de Cancerologie Prive Strasbourgeois
Strasbourg, 67000, France
Hopital Bel Air
Thionville, 57126, France
Hia Sainte Anne; Medecine Interne Oncologie
Toulon, 83041, France
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059, France
Centre Hospitalier Valence
Valence, 26953, France
Institut Gustave Roussy; Dermatologie
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 4, 2017
Study Start
October 27, 2016
Primary Completion
August 22, 2018
Study Completion
August 22, 2018
Last Updated
January 22, 2019
Record last verified: 2019-01