Clinical trial NCT03139513: 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])
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
Secondary outcomes:
measure: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
measure: Percentage of Participants with Complete Response (CR) or Partial Response (PR) to Treatment According to RECIST as Assessed by Physician
timeFrame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
measure: Time to Cobimetinib Treatment Discontinuation
timeFrame: From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
measure: Percentage of Participants by Treatments After Disease Progression or Permanent Cobimetinib Treatment Discontinuation
timeFrame: From disease progression or permanent cobimetinib treatment discontinuation up to overall study completion (assessed up to 18 months)
measure: Retrospective Period: Percentage of Participants with Targeted Adverse Events (AEs)
timeFrame: From first intake of cobimetinib up to inclusion in the study (up to Day 1)
measure: Prospective Period: Percentage of Participants with Adverse Events (AEs)
timeFrame: From first intake of cobimetinib up to overall study completion (assessed up to 18 months)
Other outcomes:
Locations:
city: Albi Cedex 9
country: France
facility: Centre Hospitalier d'Albi
city: Antony
country: France
facility: Hopital Prive D Antony; Dermatologie
city: Bayonne
country: France
facility: Chic Cote Basque Bayonne; Medecine II
city: Besançon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Bobigny
country: France
facility: Hopital Avicenne; Dermatologie
city: Bourg en Bresse
country: France
facility: CH Fleyriat
city: CHAMBERY Cedex
country: France
facility: CH Metropole de Savoie
city: Clermont Ferrand
country: France
facility: Chu Estaing; Dermatologie
city: Colmar
country: France
facility: Hopital Louis Pasteur; Sce Dermatologie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Dijon
country: France
facility: Chu Site Du Bocage;Dermatologie
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans; Dermatologie
city: Lille
country: France
facility: Hopital Claude Huriez; Sce Dermatologie
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Dupuytren
city: Marseille
country: France
facility: Hopital Timone Adultes; Dermatologie
city: Montivilliers
country: France
facility: Hopital Jacques Monod; Dermatologie
city: Montpellier
country: France
facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
city: Mulhouse
country: France
facility: CH de Mulhouse Hôpital Emile Muller
city: Nice cedex 3
country: France
facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie
city: Paris
country: France
facility: Hopital Cochin; Dermatologie
city: Paris
country: France
facility: Groupe Hospitalier Bichat Claude Bernard
city: Pringy
country: France
facility: CENTRE HOSPITALIER ANNECY-GENEVOIS; Dematologie
city: Rennes
country: France
facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer
city: Rouen
country: France
facility: CHU Rouen - CH C. Nicolle - Clinique dermatologique
city: Saint Etienne
country: France
facility: CHU de Saint-Etienne - Hopital Nord
city: Saint Germain
country: France
facility: CHI de Poissy St Germain
city: St Malo Cedex
country: France
facility: Hopital Broussais
city: Strasbourg
country: France
facility: Pole de Cancerologie Prive Strasbourgeois
city: Thionville Cedex
country: France
facility: Hopital Bel Air
city: Toulon
country: France
facility: Hia Sainte Anne; Medecine Interne Oncologie
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Valence
country: France
facility: Centre Hospitalier Valence
city: Villejuif
country: France
facility: Institut Gustave Roussy; Dermatologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: