MS100070_0114: Avelumab in real-world treatment of urothelial cancer – The AVENUE NIS

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  International, multi-center, prospective, single-arm, observational real-world/non-interventional study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  AVELUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FF04) avelumab

  avelumab
• Medical condition to be studied:
  Transitional cell cancer of the renal pelvis and ureter

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:
  342

Study design details

• Study design:
  International, multi-center, prospective, single-arm, observational real-world/non-interventional study
• Main study objective:
  This study will evaluate effectiveness and safety of Avelumab (acc. to SmPC or local label) as maintenance therapy administered after completion of 1st line platinum-based chemotherapy in patients with locally advanced or metastatic UCC (not progressed with 1st-line platinum-chemotherapy).
• Outcomes:
  - To evaluate overall survival (OS) rate at 12, 24, and 36 months after the index date (baseline visit) in patients receiving Avelumab maintenance therapy; - To assess OS and health-related quality of life (HRQoL) in patients receiving Avelumab maintenance therapy; - To evaluate anti-tumor effectiveness and safety and tolerability of Avelumab maintenance therapy; - To assess progression-free survival (PFS) on Avelumab maintenance therapy and progression-free survival 2 (PFS2) on Avelumab maintenance therapy followed by second-line treatment
• Data analysis plan:
  Descriptive analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the sample studied. Continuous variables will be described with the following measures of central tendency and dispersion: the number of patients, missing observations, mean, standard deviation, median, interquartile range, minimum, and maximum. Frequency, percentage, and number of missing observations will be provided for categorical variables. Exact Clopper-Pearson 95% CIs will be included where appropriate. The Kaplan-Meier method will be used for the analysis of time to event objectives. In general, descriptive statistics of quantitative parameters (results and change from baseline) will be provided for observed cases, that is, patients having non-missing assessments at a specific timepoint. Missing data count will be presented.