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])

Melanoma Clinical Trial

— MELANIS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139513
• Other study ID #: ML29964
• Status: Completed
• Start date: October 27, 2016
• Est. completion date: August 22, 2018

Study information

• Verified date: January 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Cobimetinib
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
• Vemurafenib
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.

Locations

Country	Name	City	State
France	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	Chu Site Du Bocage;Dermatologie	Dijon
France	Centre Hospitalier Le Mans; Dermatologie	Le Mans
France	Hopital Claude Huriez; Sce Dermatologie	Lille
France	CHU de Limoges - Hôpital Dupuytren	Limoges
France	Hopital Timone Adultes; Dermatologie	Marseille
France	Hopital Jacques Monod; Dermatologie	Montivilliers
France	Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie	Montpellier
France	CH de Mulhouse Hôpital Emile Muller	Mulhouse
France	Hopital l Archet 2; Ginestriere, Service de; Dermatologie	Nice cedex 3
France	Groupe Hospitalier Bichat Claude Bernard	Paris
France	Hopital Cochin; Dermatologie	Paris
France	CENTRE HOSPITALIER ANNECY-GENEVOIS; Dematologie	Pringy
France	Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer	Rennes
France	CHU Rouen - CH C. Nicolle - Clinique dermatologique	Rouen
France	CHU de Saint-Etienne - Hopital Nord	Saint Etienne
France	CHI de Poissy St Germain	Saint Germain
France	Hopital Broussais	St Malo Cedex
France	Pole de Cancerologie Prive Strasbourgeois	Strasbourg
France	Hopital Bel Air	Thionville Cedex
France	Hia Sainte Anne; Medecine Interne Oncologie	Toulon
France	CHU de Toulouse - Hôpital Larrey	Toulouse
France	Centre Hospitalier Valence	Valence
France	Institut Gustave Roussy; Dermatologie	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
Secondary	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)
Secondary	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)
Secondary	Time to Cobimetinib Treatment Discontinuation		From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
Secondary	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)
Secondary	Retrospective Period: Percentage of Participants with Targeted Adverse Events (AEs)	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)
Secondary	Prospective Period: Percentage of Participants with Adverse Events (AEs)		From first intake of cobimetinib up to overall study completion (assessed up to 18 months)