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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/199006
• EU PAS number:
  EUPAS108004
• Study ID:
  199006
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany
• Study description:
  The purpose of the protocol is to describe the use of cabozantinib tablets as monotherapy or in combination with nivolumab including the number of dose reductions, dose interruptions and terminations due to (serious) adverse events in subjects with advanced or metastatic renal cell carcinoma (mRCC) treated in real-life clinical setting in 1st line treatment.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 83

Study timelines

Date when funding contract was signed

Actual: 26/07/2018

Study start date

Actual: 13/08/2018

Data analysis start date

Planned: 30/06/2027

Date of interim report, if expected

Planned: 30/06/2025

Date of final study report

Planned: 30/06/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

IPSEN Pharma

Study protocol

Updated protocol

A-DE-60000-009_protocol_27Nov2023_Redacted_PDFA.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable