Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment. (CABOCARE)

May 29, 2026 updated by: Ipsen

Prospective Non-interventional Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment

The purpose of the protocol, is to describe the use of cabozantinib tablets as monotherapy or in combination with nivolumab including the number of dose reductions, dose interruptions and terminations due to (serious) adverse events in subjects with advanced or metastatic renal cell carcinoma (mRCC) treated in real-life clinical setting in 1st line treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Leoben, Austria, A-8700
        • Landeskrankenhaus Hochsteiermark
      • Linz, Austria, 4021
        • Kepler Universitatsklinikum GmbH
      • Salzburg, Austria, A-5020
        • Uniklinikum Salzburg
      • Vöcklabruck, Austria, A-4840
        • Salzkammergutklinikum Vöcklabruck
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen
      • Aachen, Germany
        • Urologisches Zentrum Euregio
      • Aschaffenburg, Germany, 63739
        • Onkologie aschaffenburg
      • Augsburg, Germany, 86156
        • Universitätsklinikum Augsburg A.ö.R
      • Bad Homburg, Germany
        • MVZ Taunus GmbH
      • Bad Liebenwerda, Germany
        • Hämatologisch-Onkologische Schwerpunktpraxis
      • Bad Schlema, Germany
        • Urologische Praxis Bad Schlema
      • Bamberg, Germany, 96049
        • Klinikum am Bruderwald Medizinische Klinik V
      • Bergisch Gladbach, Germany
        • GFO Kliniken Rhein-Berg
      • Berlin, Germany
        • Vivantes Klinikum Am Urban
      • Berlin, Germany, 12487
        • Onkologie am Segelfliegerdamm
      • Berlin, Germany, 12099
        • Praxis für Urologie
      • Berlin, Germany
        • Praxis am Volkspark
      • Berlin, Germany
        • Praxis Urologie Köpenick
      • Berlin, Germany
        • Urologische Praxis Berlin
      • Berlin, Germany
        • Zentrum für urologische Onkologie, Palliativmedizin und allgemeine Urologie
      • Bernburg, Germany
        • Urologische Arztpraxis
      • Bielefeld, Germany, 33615
        • Franziskus Hospital Bielefeld
      • Bremen, Germany
        • Klinikum Bremen Mitte
      • Bremen, Germany, 28277
        • Centrum für Operative Urologie
      • Chemnitz, Germany, 09130
        • Edia.med MVZ
      • Cottbus, Germany
        • Gemeinschaftspraxis für Urologie Cottbus
      • Donauwörth, Germany, 86609
        • Onkologisches Zentrum Donauwörth
      • Dresden, Germany, 01127
        • Onkozentrum Dresden/Freiberg
      • Dresden, Germany, 01307
        • Urologische Gemeinschaftspraxis
      • Dresden, Germany
        • Gemeinschaftspraxis Hämatologie-Onkologie, Dresden
      • Eggenfelden, Germany
        • Fachzentrum für Urologie Eggenfelden
      • Eisenach, Germany, 99817
        • St. Georg Klinikum
      • Eisleben Lutherstadt, Germany, 06295
        • Urologische Arztpraxis
      • Erlangen, Germany
        • Uniklinikum Erlangen
      • Frankfurt am Main, Germany
        • Markuskrankenhaus
      • Garbsen, Germany, 30823
        • Gemeinschaftspraxis
      • Giessen, Germany
        • Universitätsklinikum Gießen und Marburg GmbH
      • Göttingen, Germany, 37075
        • Universitatsmedizin Gottingen
      • Halle, Germany
        • Krankenhaus Martha-Maria Halle-Dölau
      • Hamburg, Germany
        • Asklepios Klinik Altona
      • Hamm, Germany, 59063
        • Evangelisches Krankenhaus Hamm gGmbH
      • Hanover, Germany, 30161
        • Onkologisches Studienzentrum am Raschplatz
      • Hanover, Germany, 30449
        • Immunologisch onkologisches MVZ
      • Herford, Germany
        • Kreiskliniken Herford
      • Jena, Germany
        • Uniklinik Jena
      • Kronach, Germany, 96317
        • Praxis für Hämatologie, Onkologie und Gerinnung
      • Kronach, Germany
        • Onkologische Schwerpunktpraxis
      • Leer, Germany
        • Studienzentrum UnterEms
      • Leipzig, Germany
        • Urologische Arztpraxis
      • Luckenwalde, Germany
        • Urologische Praxis
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg
      • Marburg, Germany
        • Uniklinik Marburg
      • Markkleeberg, Germany, 04416
        • Praxis für Urologie, Andrologie, Onkologie und medikamentöse Tumortherapie
      • Moers, Germany, 47441
        • Onkologische Praxis Moers
      • Mönchengladbach, Germany, 41063
        • Kliniken Maria Hilf GmbH
      • München, Germany, 80331
        • Facharztpraxis für Hämatologie und Internistische Onkologie
      • München, Germany
        • LMU Urologische Klinik und Poliklinik
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Naunhof, Germany
        • Praxis Naunhof
      • Neunkirchen, Germany, 66538
        • Urologische Gemeinschaftspraxis
      • Neustadt am Rübenberge, Germany, 31535
        • Praxis für Hämatologie und Internistische Onkologie
      • Nuremberg, Germany, 90419
        • Klinikum Nürnberg
      • Nuremberg, Germany
        • MVZ Urologie gGmbH
      • Offenbach, Germany
        • Sana Klinikum Offenbach GmbH
      • Olpe, Germany, 57462
        • MVZ Kreis Olpe
      • Osnabrück, Germany
        • Klinikum Osnabrück GmbH
      • Paderborn, Germany, 33098
        • Brüderkrankenhaus St. Josef Paderborn
      • Parchim, Germany, 19370
        • Urologische Praxis
      • Potsdam, Germany
        • Urologie
      • Regensburg, Germany
        • Krankenhaus Barmherzige Brüder Regensburg
      • Riesa, Germany, 01589
        • Elblandklinikum Riesa
      • Saalfeld, Germany, 07318
        • MVZ MP Saaletal
      • Schorndorf, Germany, 73614
        • Zentrum für Ambulante Onkologie
      • Sindelfingen, Germany, 71065
        • Klinikum Sindelfingen-Böblingen
      • Solingen, Germany
        • Klinikum Solingen
      • Torgau, Germany
        • Krankenhaus Torgau J. Kentmann gGmbH
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder Trier
      • Westerstede, Germany, 26655
        • Medizinische Studiengesellschaft Nord-West GmbH
      • Wilhelmshaven, Germany, 26389
        • Praxisgemeinschaft für Onkologie und Urologie
      • Witten, Germany, 58455
        • GIM - Gemeinschaftspraxis Innere Medizin
      • Zwickau, Germany
        • Praxis Urologie Köpenick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with Cabozantinib as monotherapy or in combination with nivolumab in advanced or metastatic renal cell carcinoma in 1st line treatment

Description

Inclusion Criteria:

  • Males or females aged 18 years and older with capacity to consent.
  • Subjects receiving cabozantinib as monotherapy or in combination with nivolumab as a first line treatment for advanced or metastatic renal cell carcinoma
  • Subjects with the intention to be treated with cabozantinib tablets as monotherapy or in combination with nivolumab according to the current local Summary of Product Characteristics (SmPC); decision has to be taken before entry in the study.
  • Signed written informed consent

Exclusion Criteria:

  • Participation in an interventional study at the same time and/or within 3 months before baseline.
  • Previous participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)
Time Frame: 2 years
The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall.
2 years
The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs
Time Frame: 2 years
The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.
2 years
The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs
Time Frame: 2 years
The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.
2 years
Number of injection delayed of nivolumab due to SAE/AE
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 2 years
Progression free survival is defined as the time between the start date of cabozantinib and the date of progression or death from any cause. Disease progression is defined as either radiological progression assessed by the investigator using RECIST 1.1 or clinical progression.
2 years
Best overall response - Overall Response Rate (ORR)
Time Frame: 2 years
The best overall response is the best response assessed by investigator recorded during the treatment period. ORR is defined as the proportion of subjects achieving complete or partial response.
2 years
Best overall response - Disease Control Rate (DCR)
Time Frame: 2 years
The best overall response is the best response assessed by investigator recorded during the treatment period. DCR is defined as the proportion of subjects achieving a complete response, partial response or stable disease.
2 years
All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes
Time Frame: 2 years
Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations. The adverse events will be described overall and also according to level of physical activity assessed by questionnaire and actigraph.
2 years
Impact of the activity level at baseline on the occurrence of adverse events (AEs)
Time Frame: 2 years
Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations; data of activity level and quality of life will be collected using the quality of life questionnaire (NFKSI-19 questionnaire) and the activity questionnaire; inflammatory blood markers, as routinely assessed by the investigator, will be captured.
2 years
The proportion of subjects with termination due to SAEs/AEs in sub-group
Time Frame: 2 year
The proportion of subjects with ≥1 termination due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).
2 year
The proportion of subjects with dose interruption due to SAEs/AEs in sub-group
Time Frame: 2 year
The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).
2 year
The proportion of subjects with dose reduction due to SAEs/AEs in sub-group
Time Frame: 2 years
The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ipsen Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-DE-60000-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

IPD Sharing Time Frame

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

IPD Sharing Access Criteria

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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