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NCT Number: 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])

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®).

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier d'Albi, Albi, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cobimetinib

Drug

Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.

Other names: Cotellic®

Vemurafenib

Drug

Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.

Other names: Zelboraf®

Primary outcomes

  1. Overall Survival (OS)

    Time frame: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)

Secondary outcomes

  1. 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)

  2. 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)

  3. Time to Cobimetinib Treatment Discontinuation

    Time frame: From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)

  4. 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)

  5. 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.

  6. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Acronym: MELANIS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 4, 2017
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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