Non-interventional post-marketing safety study (PMSS) to collect information on hepatic function disorders among Japanese patients with radically unresectable or metastatic renal cell carcinoma treated with pembrolizumab in combination with axitinib (MK-3475-A97)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  INLYTA

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

  PEMBROLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EK01) axitinib

  axitinib

  (L01XC18) pembrolizumab

  pembrolizumab
• Medical condition to be studied:
  Renal cell carcinoma

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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:
  200

Study design details

• Main study objective:
  Among the overall population of Japanese participants with radically unresectable or metastatic RCC who receive treatment with pembrolizumab in combination with axitinib, to describe the proportion of participants with hepatic disorders, including clinical events and/or laboratory elevations with or without hepatic dysfunction.
• Outcomes:
  Proportion of participants with hepatic adverse events (HAEs, overall, serious and grade 3 or higher), including clinical events and/or laboratory elevations with or without hepatic dysfunction, (Overall) Baseline data, % discontinuing treatment due to HAE, % with treatment interruption, % with dose reduction, time to discontinuation, interruption, resumption, and dose reduction, (participants with HAE) Baseline data, % with resolved HAE, % using steroids/other treatment, time to HAE onset, HAE summary. Subgroup analysis for HAEs will be performed (overall, serious, and >=grade 3)
• Data analysis plan:
  Analyses will be of an explorative and descriptive nature. There is no formal hypothesis testing. Descriptive statistics will be reported including measures of central tendency and dispersion for continuous variables and frequency and percentages for categorical scale variables. Comparison of characteristics in subgroups will be performed using Chi-square test or Fisher’s exact test for categorical/binary variables, and Student’s t-test for continuous data. Other test statistics may be used, as relevant, depending on the data distributions and normality assumptions.