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

Completed

• Conditions: Advanced Renal Cell Carcinoma (aRCC)

• Registration Number: NCT04957160
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-12
• Study Start: 2021-09-09
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
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)
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)
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
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)
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)
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)

Trial Locations

Locations (9)

Barts Cancer Institute; 🇬🇧 London, United Kingdom

Royal Surrey County Hospital; 🇬🇧 Guildford, United Kingdom

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, United Kingdom

Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Royal Marsden Hospital; 🇬🇧 London, United Kingdom

Nottingham University Hospital; 🇬🇧 Nottingham, United Kingdom

Royal Preston Hospital; 🇬🇧 Preston, United Kingdom

Clatterbridge Road, Bebington; 🇬🇧 Wirral, United Kingdom

Mount Vernon Cencer Centre; 🇬🇧 Welwyn Garden City, United Kingdom