A post-licensure prospective observational registry study in real-world Taiwanese cancer patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) genes

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  KEYTRUDA
• Study drug International non-proprietary name (INN) or common name:
  PEMBROLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC18) pembrolizumab

  pembrolizumab
• Medical condition to be studied:
  Microsatellite instability cancer

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:
  20

Study design details

• Main study objective:
  The main objectives are to describe demographic and clinicopathological characteristics and to describe objective response rate and duration of response in Taiwanese participants with advanced unresectable or MSI-H or dMMR cancers and who have progressed on prior standard therapy.
• Outcomes:
  The primary outcomes are the demographic and clinicopathological characteristics, objective response rate (ORR), and duration of response (DOR). The secondary outcomes are treatment-emergent adverse events (TEAEs) as reported during routine clinical care, progression-free survival (PFS), and overall survival (OS).
• Data analysis plan:
  Descriptive analysis, including univariate analyses and cross tabulations, will be used for presenting baseline demographic and clinicopathological characteristics of the MSI-H/dMMR participants included in this study. ORR is defined as the combined proportion of participants with a Complete Response (CR) or Partial Response (PR) tumor response per the investigator's assessment, presented as a percentage with corresponding 95% confidence interval (CI). DOR is measured from the time of initial response until the time at which it is determined that tumor progression occurs. Kaplan-Meier plots will be generated to describe DOR with median DOR estimated along with the corresponding 95% CI.