MELANIS - 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)
Head :
Roche Medical data center
Last update : 11/08/2021 | Version : 1 | ID : 74085
| General | |
| Identification | |
| Detailed name | 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) |
| Sign or acronym | MELANIS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML29964 |
| General Aspects | |
| Medical area |
Cancer research Dermatology, venereology |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Onco dermatology, BRAF V600 melanoma |
| Health determinants |
Medicine |
| Keywords | cobimetinib |
| Scientific investigator(s) (Contact) | |
| Name of the director | Roche Medical data center |
| Address | 4 cours de l'Ile Seguin - 92100 Boulogne-Billancourt |
| data_sharing.france@roche.com | |
| Organization | Roche SAS |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Roche SAS |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
Primary Objective: To estimate the OS of patients treated with cobimetinib in combination with vemurafenib
Secondary Objectives: - To assess the PFS - To identify prognostic factors of OS - To identify prognostic factors of PFS - To describe response to treatment (overall assessment of the physician) - To describe time to treatment discontinuation. - To characterize the targeted AE of cobimetinib in combination with vemurafenib under real-world conditions of useTo describe the long term safety profile of cobimetinib in association with vemurafenib under real-world conditions of use Exploratory Objectives: - To describe population of patients treated with cobimetinib in combination with vemurafenib - To describe the use of cobimetinib in combination with vemurafenib |
| Inclusion criteria |
Inclusion criteria:
- Patients at least 18 years-old - Patients included in the TAU from 26 February 2015 - Patients with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with Zelboraf® (vemurafenib) - For alive patients: patients 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 and who have signed the consent form OR - For patients who died before the inclusion period: patients who did not expressed their opposition when they were alive. Exclusion criteria: - Alive patients unable to give informed consent - Patients previously included in cobimetinib clinical trial. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue |
| Gender |
Male Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2016 |
| Date of last collection (YYYY or MM/YYYY) | 2018 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 198 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Type of data collected : informed consent, inclusion/exclusion criteria, date of the visit, demographic data, clinical data, medical history, disease history and prior melanoma therapies, treatment with cobimetinib, concomitant medications for melanoma (including vemurafenib), first disease progression, evaluation of lesions (as assessed by the physician), vital status, targeted adverse events (before inclusion), adverse events (after inclusion), early study termination. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Procedures | |
| Data collection method | eCRF |
| Classifications used | CDISC like |
| Quality procedure(s) used | GCP/GVP |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Followed pathology | C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Presence of document that lists variables and coding procedures |
Yes |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
