CARINA: Cabozantinib Post First-line Immuno-oncology Checkpoint Inhibitor Containing Combination
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1
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| Cohort 2
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Outcome Measures
Primary Outcome Measures
- Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC [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)]
To be described for patients with aRCC receiving 2L treatment following a 1L IO containing combination therapy.
- Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC [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)]
To be described for patients with aRCC receiving 2L treatment and subsequent lines of treatment following a 1L IO containing combination therapy.
Secondary Outcome Measures
- 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 [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)]
Descriptive statistics using following parameters: no dose change, dose change, dose increase and dose decrease
- 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 [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)]
Descriptive statistics using the following parameters: radiological disease progression, clinical deterioration, AE, subject's decision, Investigator's decision, end of predefined treatment, other
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with a diagnosis of aRCC.
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Patients aged ≥18 years at aRCC diagnosis treated with a 1L IO containing combination therapy who have progressed to a 2L treatment.
Exclusion Criteria:
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Patient's hospital medical records are unavailable for review;
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Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | G12 0XH | |
| 2 | Royal Surrey County Hospital | Guildford | United Kingdom | GU2 7XX | |
| 3 | Barts Cancer Institute | London | United Kingdom | E1 2ES | |
| 4 | Royal Marsden Hospital | London | United Kingdom | SW3 6JJ | |
| 5 | Christie NHS Foundation Trust | Manchester | United Kingdom | M20 4BX | |
| 6 | Nottingham University Hospital | Nottingham | United Kingdom | NG5 1PB | |
| 7 | Royal Preston Hospital | Preston | United Kingdom | PR2 9HT | |
| 8 | Mount Vernon Cencer Centre | Welwyn Garden City | United Kingdom | AL8 6JL | |
| 9 | Clatterbridge Road, Bebington | Wirral | United Kingdom | CH63 4JY |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLIN-60000-451