A Non-interventional Real-World Study on Dose Modifications of Enfortumab Vedotin (EV) in Combination with Pembrolizumab (P) in Previously Untreated Patients with Advanced Urothelial Carcinoma in Germany

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)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  KEYTRUDA

  PADCEV
• Study drug International non-proprietary name (INN) or common name:
  ENFORTUMAB VEDOTIN

  PEMBROLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FF02) pembrolizumab

  pembrolizumab

  (L01FX13) enfortumab vedotin

  enfortumab vedotin
• Additional medical condition(s):
  Metastatic urothelial carcinoma

Population studied

• Short description of the study population:
  This study is for adults in Germany who have cancer in the bladder lining that has spread to tissue close by or to other parts of the body (advanced urothelial cancer). The people’s advanced urothelial cancer has not previously been treated.; ; The people in this study will receive enfortumab vedotin and pembrolizumab as part of their usual treatment for their cancer.
• Age groups:
  Adult and elderly population (≥18 years)
• Estimated number of subjects:
  150

Study design details

• Study design:
  This is a single arm, multi-center, non-interventional prospective cohort study which aims to describe the use of Enfortumab Vedotin + Pembrolizumab especially, the dose modification, in previously untreated patients with unresectable or metastatic urothelial cancer.
• Main study objective:
  The main aim of the study is to learn about any changes in the doses of enfortumab vedotin and/or pembrolizumab people receive. Information about dose changes, temporary pauses, or a complete stop of either treatment will be collected. The study will last about 2 years.
• Outcomes:
  Dose modification (dose reduction, temporary interruption, permanent discontinuation) for enfortumab vedotin and/or Pembrolizumab ;
• Data analysis plan:
  In order to describe the frequency of real-world dose modifications in 1L unresectable or metastatic urothelial cancer patients receiving enfortumab vedotin + pembrolizumab, dose modification of enfortumab vedotin and/or pembrolizumab will be analyzed as a composite variable of dose reduction, temporary dose interruption, and permanent discontinuation. The frequency of patients experiencing dose modification will be descriptively analyzed. Cumulative incidence of dose modification will be estimated using survival analysis; death will be considered a competing event.