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

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

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 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
        • Universitätsklinikum Münster
      • 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

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

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

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

Ipsen

Investigators

  • 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)

September 24, 2018

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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