Real-world use of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy: a multicenter, retrospective, non-interventional study in France

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  To describe the real-world effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional secondary data-use study

Study drug and medical condition

• Medicinal product name:
  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

Population studied

• Short description of the study population:
  patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 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:
  206

Study design details

• Study design:
  This study is multicenter, retrospective, non-interventional study conducted in France that does not involve the human person as defined in the French legislation (RNIPH, recherche n’impliquant pas la personne humaine).
• Main study objective:
  To describe real-world effectiveness of EV based on overall survival (OS)
• Outcomes:
  To describe real-world effectiveness of EV based on OS. ; To describe real-world effectiveness of EV based on:; - Progression free survival; - Time to treatment discontinuation; - Time to next treatment; - Objective response rate; - Disease control rate; - Baseline characteristics of participants who initiated treatment with EV; - Describe real-world treatment patterns of EV; - Safety data related to the use of EV in the real world
• Data analysis plan:
  No hypothesis will be tested in this study as it is a descriptive, non-interventional, retrospective study.