Advanced Renal Cell Carcinoma (aRCC)CARINANCT04957160
Cabozantinib Post First-line Immuno-oncology Checkpoint Inhibitor Containing Combination
An observational study of Advanced Renal Cell Carcinoma (aRCC), run by Ipsen at 9 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma (aRCC)
- How many people
- 281 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 9 Sep 2021to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient's hospital medical records are unavailable for review;
- Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Beatson West of Scotland Cancer Centre
Glasgow, G12 0XH
Royal Surrey County Hospital
Guildford, GU2 7XX
Barts Cancer Institute
London, E1 2ES
Royal Marsden Hospital
London, SW3 6JJ
Christie NHS Foundation Trust
Manchester, M20 4BX
Clatterbridge Road, Bebington
Metropolitan Borough of Wirral, CH63 4JY
Nottingham University Hospital
Nottingham, NG5 1PB
Royal Preston Hospital
Preston, PR2 9HT
Mount Vernon Cencer Centre
Welwyn Garden City, AL8 6JL
About this study
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)
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.
- Conditions
- Advanced Renal Cell Carcinoma (aRCC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Not described | |
| Cohort 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 (12)
Overall Survival (OS)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start9 Sep 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Renal Cell Carcinoma (aRCC)Studies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957160
- Sponsor's protocol ID
- CLIN-60000-451
- Acronym
- CARINA
- Status last verified
- Dec 2024
- First submitted
- 12 Jan 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39107157
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04957160
- Acronym / sponsor ID
- CARINA / CLIN-60000-451
- Conditions
- Advanced Renal Cell Carcinoma (aRCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | – |
| Cohort 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient's hospital medical records are unavailable for review;
- Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC
Time frame: 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
Time frame: 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.
12 secondary outcomes
Overall Survival (OS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 39107157Nathan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Renal Cell Carcinoma (aRCC), run by Ipsen at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04957160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.