Cabozantinib Post First-line Immuno-oncology Checkpoint Inhibitor Containing Combination

Study Overview
=================
Brief Summary
-----------------
This study will collect real-world data for the new treatment pathways for all patients with Advanced Renal Cell Carcinoma (ARCC) who were treated with a 1L IO (first-line, Immuno-Oncology checkpoint inhibitor) combination therapy and progressed to a 2L treatment with particular focus to understanding where cabozantinib is prescribed after 1L IO containing combination therapy.

Official Title
-----------------
A Multicentre, Retrospective, Non-interventional Review of Electronic Prescribing Records of Any Second-line (2L) Patients and Chart Notes of 2L Cabozantinib Patients, Investigating the Treatment Sequence Pathway Following a First-line, Immuno-oncology Checkpoint Inhibitor (1L IO) Containing Combination Therapy in Patients With Advanced Renal Cell Carcinoma (aRCC) (CARINA)

Conditions
-----------------
Advanced Renal Cell Carcinoma (aRCC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of aRCC. Patients aged ≥18 years at aRCC diagnosis treated with a 1L IO containing combination therapy who have progressed to a 2L treatment. Exclusion Criteria: Patient's hospital medical records are unavailable for review; Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br> | |
| Cohort 2<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC | To be described for patients with aRCC receiving 2L treatment following a 1L IO containing combination therapy. | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC | To be described for patients with aRCC receiving 2L treatment and subsequent lines of treatment following a 1L IO containing combination therapy. | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Time to Treatment Discontinuation (TTD) by line |  | From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022) | 
| Physician defined Best Response by line - complete response, partial response, stable disease, progressive disease |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Overall Response Rate (ORR) by line -complete response or partial response |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Duration of treatment by line |  | From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022) | 
| Drug start and end dose by line | Descriptive statistics using following parameters: no dose change, dose change, dose increase and dose decrease | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Disease Control Rate (DCR) by line - complete response, partial response and stable disease |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Progression Free Survival (PFS) by line for cabozantinib patients |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Reason for stopping cabozantinib | Descriptive statistics using the following parameters: radiological disease progression, clinical deterioration, AE, subject's decision, Investigator's decision, end of predefined treatment, other | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Reason for dose change (Disease progression, AE, subject non-compliance, subject decision, clinical / Investigator decision, radiotherapy(s), surgery(s), COVID-19 pandemic, other) |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Describe interruptions for cabozantinib |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | 
| Cause of death (RCC or non RCC related) |  | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) |