MS100070_0031: Non-interventional cohort registry study to assess characteristics and management of patients with Merkel Cell Carcinoma in Germany (MCC-TRIM)

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

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

  avelumab
• Medical condition to be studied:
  Skin cancer
• Additional medical condition(s):
  Merkel cell carcinoma

Population studied

• Short description of the study population:
  Patients were recruited based on a diagnosis of MCC only (all stages and ages), irrespective of treatment and MCC diagnosis tool utilized, from study start (30 April 2019) until 30 September 2023
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  1000

Study design details

• Study design:
  This was a 5-year non-interventional (observational), longitudinal, multi-site cohort study
• Main study objective:
  Enlarge ADO MCC Registry by collecting additional data on treatment patterns, comorbidities, concomitant treatments, effectiveness and safety outcomes, HRU and biomarker Information.; This study aims to identify and describe population of MCC patients, their treatment and outcomes in a real-world settings in Germany.
• Setting:
  The study population was recruited by healthcare providers (HCPs) participating in ADOREG, mainly dermato; oncologists, treating and managing patients with MCC in Germany
• Outcomes:
  In patients diagnosed with MCC in Germany; • Patient and tumor characteristics; • Background prevalence rates ; • MCC-related treatments for all types and lines of therapy since initial diagnosis of MCC; • Relevant common comorbidities in patients with metastatic stage disease; • Concomitant medications; • Disease outcomes by means of response and survival analyses ; • Safety events of interest
• Data analysis plan:
  All statistical analysis will be done using SAS version 9.4 or higher. For categorical variables, summary tabulations of number and percentage within each category (with a category for missing data) of parameter will be presented. For continuous variables, mean, median, standard deviation, minimum and maximum values will be given. All time-to-event analyses will be performed by using Kaplan-Meier methods including calculation of median survival times and 95% confidence intervals (CIs).; Safety analysis will mainly involve assessment of incidence rates (e.g. fatal and nonfatal ADRs, rate of immune-related ADRs). ; In addition, as this is an open cohort, accumulation of evidence will continue over the study duration. Data will be analyzed every 6 months as information from more patients is accumulated over the 5-year study period. ; The study sponsor will also be able to perform ad hoc queries using the cohort data throughout the duration of the study period of 5 years.