Melanoma
Conditions
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.
Interventions
DRUGCobimetinib
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
DRUGVemurafenib
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| 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) | 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. |
| Prospective Period: Percentage of Participants with Adverse Events (AEs) | From first intake of cobimetinib up to overall study completion (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) | — |
Countries
France
Outcome results
None listed