Clinical trial NCT04957160: Cabozantinib Post First-line Immuno-oncology Checkpoint Inhibitor Containing Combination
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Renal Cell Carcinoma (aRCC)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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).

Primary outcomes:
measure: Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC
timeFrame: 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 of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC
timeFrame: 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 outcomes:
measure: Overall Survival (OS)
timeFrame: 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: Time to Treatment Discontinuation (TTD) by line
timeFrame: 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)
measure: Physician defined Best Response by line - complete response, partial response, stable disease, progressive disease
timeFrame: 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: Overall Response Rate (ORR) by line -complete response or partial response
timeFrame: 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: Duration of treatment by line
timeFrame: 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)
measure: Drug start and end dose by line
timeFrame: 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: Disease Control Rate (DCR) by line - complete response, partial response and stable disease
timeFrame: 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: Progression Free Survival (PFS) by line for cabozantinib patients
timeFrame: 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: Reason for stopping cabozantinib
timeFrame: 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: Reason for dose change (Disease progression, AE, subject non-compliance, subject decision, clinical / Investigator decision, radiotherapy(s), surgery(s), COVID-19 pandemic, other)
timeFrame: 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: Describe interruptions for cabozantinib
timeFrame: 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: Cause of death (RCC or non RCC related)
timeFrame: 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)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: Barts Cancer Institute
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Welwyn Garden City
country: United Kingdom
facility: Mount Vernon Cencer Centre
city: Wirral
country: United Kingdom
facility: Clatterbridge Road, Bebington
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: