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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | |||
| Cohort 2 |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be conducted in 10 UK hospitals that have patients who have been treated with a 1L IO containing combination therapy and have progressed to, and started, a 2L treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0XH | United Kingdom | |||
| Royal Surrey County Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39107157 | Derived | Nathan P, Venugopal B, Ali J, Allison J, Ceruso M, Charnley N, Griffiths R, Michael A, Moore K, Perrot V, Prendergast A, Sharma A, Szabados B, Larkin J. Real-world Treatment Sequencing and Outcomes With Cabozantinib After First-line Immune Checkpoint Inhibitor-based Combination Therapy For Patients With Advanced Renal Cell Carcinoma: CARINA Study Results. Clin Genitourin Cancer. 2024 Oct;22(5):102141. doi: 10.1016/j.clgc.2024.102141. Epub 2024 Jun 26. |
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| 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) |
| Guildford |
| GU2 7XX |
| United Kingdom |
| Barts Cancer Institute | London | E1 2ES | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Clatterbridge Road, Bebington | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Nottingham University Hospital | Nottingham | NG5 1PB | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| Mount Vernon Cencer Centre | Welwyn Garden City | AL8 6JL | United Kingdom |