Real-World Treatment Patterns and Clinical Outcomes of BRAF V600-Mutant Metastatic Melanoma Patients Treated at Academic Oncology Centers in the United States

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  BRAFTOVI

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

  BINIMETINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EC03) encorafenib

  encorafenib

  (L01EE03) binimetinib

  binimetinib
• Medical condition to be studied:
  Metastatic malignant melanoma

Population studied

• Short description of the study population:
  BRAF V600 Mutant Metastatic Melanoma Patients
• Age groups:
  • Adult and elderly population (≥18 years)

Study design details

• Study design:
  A non-interventional (NI) longitudinal cohort design will be employed for this study. ; Deidentified patient data collected retrospectively from academic oncology centers will be used to address all study objectives.
• Main study objective:
  8.1. Primary Objectives; 1. Describe the real-world treatment patterns (i.e., MM treatments, treatment interruptions, reasons for treatment interruptions, treatment discontinuations, reasons for treatment discontinuations, treatment switch, time to treatment discontinuation[TTD], time to treatment switch [TTS], time to next treatment or death [TTNTD]) of ; patients with BRAF V600-mutant MM, overall and for specific treatment regimens, classes, or sequences (as determined with clinical input); 2. Describe the baseline demographic and clinical characteristics of patients with BRAF V600-mutant MM, overall and for specific treatment regimens, classes, or sequences
• Setting:
  This study will be conducted in patients with BRAF V600-mutant MM receiving treatment with SOC regimens of interest at academic oncology centers contributing to the [Redacted] from January 1, 2018 to June 30, 2024 (or most recent date of data availability).
• Outcomes:
  Outcomes includetreatment patterns(i.e., treatment regimens, number of LOTs received, treatment interruptions, reasons for treatment interruptions, treatment switch, TTS, TTNTD, treatment discontinuation, TTD, reasons ; for treatment discontinuation, treatment sequences), and clinical outcomes (i.e., PFS, and OS).