CARINA

Status: Open

Specialty: Renal

Date Opened: 06/10/2021

Planned Close Date: 28/02/2022

Sponsor: IPSEN

Principal Investigator: Dr Natalie Charnley

Study Title: CARINA Study: A multicentre, non-interventional, retrospective chart note review investigating the treatment sequence pathway for cabozantinib following a 1L IO (first-line, immuno-oncology checkpoint inhibitor) containing combination in advanced renal cell carcinoma (aRCC) patients

CARINA Study: A multicentre, non-interventional, retrospective chart note review investigating the treatment sequence pathway for cabozantinib following a 1L IO (first-line, immuno-oncology checkpoint inhibitor) containing combination in advanced renal cell carcinoma (aRCC) patients

Over the last ten years, the treatment of advance Renal Cell Carcinoma (aRCC) has seen the introduction of a number of new classes of drugs which have been used as monotherapies or in combination to improve patient outcomes.

CARINA is a non-interventional retrospective study looking at the treatment pathways of this patient group using real world data.

The study is in two phases:

Phase 1 will look back at the medical history of those patients with aRCC, where first line (1L) treatment included immuno-oncology checkpoint inhibitor (IO) drugs and that received at least a second line of treatment.

Immuno-oncology checkpoint inhibitors are a type of drug that works by releasing a natural brake on the immune system so that immune cells called T cells recognize and attack cancer cells.

Data elements will be collected from information routinely and previously recorded in the electronic prescribing records (EPRs). Some patient records will require data supplementation from chart notes.

Phase 2 will look in more detail at a sub set of patients identified in Phase 1 that received the drug Cabozantinib. Data will be collected from both EPRs and individual patient chart notes from 1L and for all subsequent lines of treatment.

The patient observation period will depend on when a patient starts 2L treatment, which may occur between January 2015 and June 2021. Data will be collected from January 2021 to June 2021.

Patients will not directly contribute to this study.

Around 400 patients will be included by 10 sites across the UK.