Advanced Renal Cell Carcinoma (All Subtypes)NCT04147143
CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
An observational study of Advanced Renal Cell Carcinoma (All Subtypes) and Metastatic Renal Cell Carcinoma (All Subtypes), run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 2 sites in Germany.
Trial summary
This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma (All Subtypes), Metastatic Renal Cell Carcinoma (All Subtypes)
- What is being tested?
- Documentation
- How many people
- 56 participants
- Where
- 2 sitesGermany
- Study dates
- 8 Mar 2019to 28 Feb 2021
- 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: Adults ≥ 18 years with advanced or metastatic renal cell carcinoma (all subtypes) who have completed treatment with nivolumab or nivolumab plus ipilimumab (any line of systemic therapy) directly followed by cabozantinib treatment
Who may be able to join
- Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject
- Patients with advanced or metastatic renal cell carcinoma, including all subtypes
- Age ≥ 18 years
- Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment
Who cannot join
- Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
- Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Uniklinik Essen
Essen, North Rhine-Westphalia, 45147
Uniklinik Münster
Münster, North Rhine-Westphalia, 48147
About this study
Official title: Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.
- Conditions
- Advanced Renal Cell Carcinoma (All Subtypes), Metastatic Renal Cell Carcinoma (All Subtypes)
- Being tested
- Documentation
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocumentationOther
Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
number of dose reductions
number of dose reductions
Measured: through study completion, an average of 1 year
number of dose interruptions
number of dose interruptions
Measured: through study completion, an average of 1 year
number of terminations of cabozantinib treatment due to adverse events
number of terminations of cabozantinib treatment due to adverse events
Measured: through study completion, an average of 1 year
ORR
ORR (investigator assessed; acc. RECIST v1.1 if available)
Measured: through study completion, an average of 1 year
Clinical benefit rate (CBR)
Clinical benefit rate (CBR)
Measured: through study completion, an average of 1 year
Duration of response
Duration of response in months
Measured: through study completion, an average of 1 year
Duration of cabozantinib treatment
Duration of cabozantinib treatment in months
Measured: through study completion, an average of 1 year
Time to next treatment
Time to next treatment in months
Measured: From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months
Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data
Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data
Measured: through study completion, an average of 1 year
Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR)
Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start8 Mar 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Due to insufficient recruitment rate, recruitmend has been terminated after inclusion of 56 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Renal Cell Carcinoma (All Subtypes)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof. Dr., Study director, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147143
- Sponsor's protocol ID
- CaboCHECK
- Status last verified
- Dec 2022
- First submitted
- 24 Oct 2019
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
- ClinicalTrials.gov ID
- NCT04147143
- Acronym / sponsor ID
- CaboCHECK
- Conditions
- Advanced Renal Cell Carcinoma (All Subtypes), Metastatic Renal Cell Carcinoma (All Subtypes)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to insufficient recruitment rate, recruitmend has been terminated after inclusion of 56 patients
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 31 Oct 2019 (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 is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ≥ 18 years with advanced or metastatic renal cell carcinoma (all subtypes) who have completed treatment with nivolumab or nivolumab plus ipilimumab (any line of systemic therapy) directly followed by cabozantinib treatment
Key inclusion criteria (4 listed)
- Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject
- Patients with advanced or metastatic renal cell carcinoma, including all subtypes
- Age ≥ 18 years
- Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment
Key exclusion criteria (2 listed)
- Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
- Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocumentationRetrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion. | Other | – |
Primary outcome
Incidence of serious adverse events
Time frame: through study completion, an average of 1 year
Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment
10 secondary outcomes
number of dose reductions
Time frame: through study completion, an average of 1 year
number of dose interruptions
Time frame: through study completion, an average of 1 year
number of terminations of cabozantinib treatment due to adverse events
Time frame: through study completion, an average of 1 year
ORR
Time frame: through study completion, an average of 1 year
Clinical benefit rate (CBR)
Time frame: through study completion, an average of 1 year
Duration of response
Time frame: through study completion, an average of 1 year
Duration of cabozantinib treatment
Time frame: through study completion, an average of 1 year
Time to next treatment
Time frame: From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months
Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data
Time frame: through study completion, an average of 1 year
Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR)
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Due to insufficient recruitment rate, recruitmend has been terminated after inclusion of 56 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No. No IPD will be shared
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.
Salah-Eddin Al-Batran, Prof. Dr. study director
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
2 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 (All Subtypes) and Metastatic Renal Cell Carcinoma (All Subtypes), run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 2 sites in Germany.
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 4 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: stopped early, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 was stopped early (reason given: Due to insufficient recruitment rate, recruitmend has been terminated after inclusion of 56 patients). Results are not available in the source record.
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?
Incidence of serious adverse events (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2022.