Enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy: a multicenter, non-interventional study in Italy (EVIDENCE)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  To describe the real-world effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional primary and secondary data collection

Study drug and medical condition

• Name of medicine:
  PADCEV
• Study drug International non-proprietary name (INN) or common name:
  ENFORTUMAB VEDOTIN
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX13) enfortumab vedotin

  enfortumab vedotin
• Medical condition to be studied:
  Transitional cell carcinoma
• Additional medical condition(s):
  Locally advanced or metastatic urothelial cancer

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  To describe the safety and tolerability of EV, in a real-world setting.
• Outcomes:
  To describe the safety and tolerability of EV, in a real-world setting, To describe real-world effectiveness of EV based on: o How EV drug-related AEs impacted course of treatment o Characteristics of patients treated with EV in real-world clinical practice o Real-world treatment patterns of EV o Real-world effectiveness of EV.
• Data analysis plan:
  No hypothesis will be tested in this study as it is a descriptive, non-interventional retrospective study.