A NON-INTERVENTIONAL STUDY TO INVESTIGATE THE EFFECTIVENESS, SAFETY AND UTILIZATION OF COBIMETINIB AND VEMURAFENIB IN PATIENTS WITH AND WITHOUT BRAIN METASTASIS WITH BRAF V600 MUTANT MELANOMA UNDER REAL WORLD CONDITIONS (coveNIS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  COBIMETINIB

  VEMURAFENIB
• Additional medical condition(s):
  unresectable and metastatic melanoma with a BRAF V600 mutation

Population studied

• Short description of the study population:
  Patients receiving treatment for BRAF V600-mutated unresectable or metastatic mM with a combination of vemurafenib and cobimetinib according to standard of care and in line with the current summary of product characteristics (SmPC)/local labeling and who have no contraindication to a treatment with a combination of vemurafenib and cobimetinib therapy as per the local label are eligible for observation in this non interventional study if the following criteria applies. ; Patients must meet the following criteria for study entry: ; • Adult patients with unresectable or metastatic melanoma with a BRAF 1/600 mutation according to SmPC ; • Be willing and able to provide informed consent for the non-interventional study. ; • Male or female patient being 2 18 years of age on day of signing informed consent. ; • Histologically confirmed diagnosis of unresectable or metastatic mM (according to the cobimetinib label) ; • Presence of BRAF mutation (V600) in tumor tissue prior to enrolment. ; ; Patients who meet any of the following criteria will be excluded from study entry: ; • Previous treatment with BRAF- and/or MEK inhibitors prior to study entry ; • Hypersensitivity to the active substances or to any of the excipients
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple Myeloma patients
• Estimated number of subjects:
  225

Study design details

• Main study objective:
  The primary objective for this study is as follows: To estimate OS according to cohorts with cerebral and without cerebral metastases
• Outcomes:
  Primary Variable The primary outcome measure for this study is Overall Survival (OS), Secondary Variables: Progression free survival (PFS), Objective response rates (ORR), Time to CNS relapse/development of cerebral metastases, Description of previous therapies and therapies after cobimetinib/ vemurafenib discontinuation, Description of Radiotherapy, Description of Concomitant medication, Quality of life (QoL)
• Data analysis plan:
  All effectiveness and safety variables documented in this study will be analyzed by means of descriptive analyses. Continuous data will be summarized using mean, standard deviation, median, minimum and maximum. Categorical variables will be expressed as absolute and relative number and 95% CI. Kaplan-Meier estimates and Cox-regression will be used to model data on time to disease progression and OS.