Prospective Non-interventional Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment (CABOCARE)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective German and Austrian multicenter non-interventional study (NIS)

Study drug and medical condition

• Name of medicine:
  CABOMETYX

  OPDIVO
• Study drug International non-proprietary name (INN) or common name:
  CABOZANTINIB

  NIVOLUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EX07) cabozantinib

  cabozantinib

  (L01FF01) nivolumab

  nivolumab
• Medical condition to be studied:
  Renal cell carcinoma

  Metastatic renal cell carcinoma

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:
  210

Study design details

• Main study objective:
  Describe the use of CabometyxTM (cabozantinib) tablets as monotherapy and the use of CabometyxTM and OpdivoTM combination including the number of dose reductions, dose interruptions and terminations due to SAEs/AEs in subjects with advanced or metastatic renal cell carcinoma treated in real-life clinical setting in 1st line treatment overall and split by risk score.
• Outcomes:
  - The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs).; - The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs.; - The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs.; - Number of injection delayed of nivolumab due to SAE/AE.; - Progression free survival.; - Best overall response.; - Overall Response Rate Best overall response.; - Disease Control Rate All non-serious and serious adverse events (SAEs/AEs) and fatal outcomes.; - Impact of the activity level at baseline on the occurrence of adverse events.; - Proportion of subjects with termination due to SAEs/AEs.; - Proportion of subjects with dose reduction due to SAEs/AEs.
• Data analysis plan:
  As this is a non-interventional study, no formal statistical testing will be performed, and all the analyses will be primarily descriptive in nature.