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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Métropole 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-Étienne - 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 - Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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