Retrospective Chart Review Study of First-Line Treatment Patterns and Clinical Outcomes in Patients with Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom (1L Melanoma Chart Review Study in UK)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Safety management

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Additional medical condition(s):
  Advanced (unresectable or metastatic) melanoma

Population studied

• 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)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To determine the first-line best overall response (BOR) rate in a subset of treatment-naïve patients who received first-line nivolumab+ipilimumab combination therapy
• Outcomes:
  Best overall tumour response (complete response (CR), partial response (PR), stable disease, progressive disease, not evaluable, unknown) will be assessed. Best overall response rate (BOR) will be defined as total number of patients whose BOR between treatment initiation and earliest of initiation of next line of therapy or chart abstraction date = CR or PR, divided by total number of patients. Patient demographics, disease characteristics, prior melanoma treatment history, first-line systemic therapy treatment patterns, treatment sequencing, clinical outcomes (treatment-free interval, progression-free survival, 12 month overall survival), proportion of patients tested for PD-L1 status, safety, safety management, healthcare resource utilisation
• Data analysis plan:
  Data analysis will be primarily descriptive. For continuous variables, mean, standard deviation, median, minimum, and maximum will be provided, and for categorical variables, numbers and percentages for each category will be provided. Analysis will be stratified by sub-groups (e.g. biomarker status, treatment type) where data availability permits. treatment-free interval, progression-free survival, and 12 month overall survival will be analysed using the Kaplan-Meier method. Chi-squared tests may be used to identify potential patient characteristics associated with first-line therapy selection and predictors of response, for patients on regimen. Additionally, binary or multinomial logistic regression or Mantel-Haenszel procedure and Cox proportional hazards model may be used.