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
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
1 other identifier
observational
224
2 countries
82
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Longer than P75 for all trials
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedStudy Start
First participant enrolled
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 30, 2026
April 1, 2026
9 years
July 25, 2018
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)
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
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
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
2 years
Secondary Outcomes (8)
Progression free survival (PFS)
2 years
Best overall response - Overall Response Rate (ORR)
2 years
Best overall response - Disease Control Rate (DCR)
2 years
All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes
2 years
Impact of the activity level at baseline on the occurrence of adverse events (AEs)
2 years
- +3 more secondary outcomes
Eligibility Criteria
Patients treated with Cabozantinib as monotherapy or in combination with nivolumab in advanced or metastatic renal cell carcinoma in 1st line treatment
You may qualify if:
- 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
You may not qualify if:
- Participation in an interventional study at the same time and/or within 3 months before baseline.
- Previous participation in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (82)
Landeskrankenhaus Hochsteiermark
Leoben, A-8700, Austria
Kepler Universitätsklinikum GmbH
Linz, 4021, Austria
Uniklinikum Salzburg
Salzburg, A-5020, Austria
Salzkammergutklinikum Vöcklabruck
Vöcklabruck, A-4840, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Universitätsklinikum Aachen
Aachen, Germany
Urologisches Zentrum Euregio
Aachen, Germany
Onkologie aschaffenburg
Aschaffenburg, 63739, Germany
Universitätsklinikum Augsburg A.ö.R
Augsburg, 86156, Germany
MVZ Taunus GmbH
Bad Homburg, Germany
Hämatologisch-Onkologische Schwerpunktpraxis
Bad Liebenwerda, Germany
Urologische Praxis Bad Schlema
Bad Schlema, Germany
Klinikum am Bruderwald Medizinische Klinik V
Bamberg, 96049, Germany
GFO Kliniken Rhein-Berg
Bergisch Gladbach, Germany
Praxis für Urologie
Berlin, 12099, Germany
Onkologie am Segelfliegerdamm
Berlin, 12487, Germany
Praxis am Volkspark
Berlin, Germany
Praxis Urologie Köpenick
Berlin, Germany
Urologische Praxis Berlin
Berlin, Germany
Vivantes Klinikum am Urban
Berlin, Germany
Zentrum für urologische Onkologie, Palliativmedizin und allgemeine Urologie
Berlin, Germany
Urologische Arztpraxis
Bernburg, Germany
Franziskus Hospital Bielefeld
Bielefeld, 33615, Germany
Centrum für Operative Urologie
Bremen, 28277, Germany
Klinikum Bremen Mitte
Bremen, Germany
Edia.med MVZ
Chemnitz, 09130, Germany
Gemeinschaftspraxis für Urologie Cottbus
Cottbus, Germany
Onkologisches Zentrum Donauwörth
Donauwörth, 86609, Germany
Onkozentrum Dresden/Freiberg
Dresden, 01127, Germany
Urologische Gemeinschaftspraxis
Dresden, 01307, Germany
Gemeinschaftspraxis Hämatologie-Onkologie, Dresden
Dresden, Germany
Fachzentrum für Urologie Eggenfelden
Eggenfelden, Germany
St. Georg Klinikum
Eisenach, 99817, Germany
Urologische Arztpraxis
Eisleben Lutherstadt, 06295, Germany
Uniklinikum Erlangen
Erlangen, Germany
Markuskrankenhaus
Frankfurt am Main, Germany
Gemeinschaftspraxis
Garbsen, 30823, Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, Germany
Universitätsmedizin Göttingen
Göttingen, 37075, Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, Germany
Asklepios Klinik Altona
Hamburg, Germany
Evangelisches Krankenhaus Hamm gGmbH
Hamm, 59063, Germany
Onkologisches Studienzentrum am Raschplatz
Hanover, 30161, Germany
Immunologisch onkologisches MVZ
Hanover, 30449, Germany
Kreiskliniken Herford
Herford, Germany
Uniklinik Jena
Jena, Germany
Praxis für Hämatologie, Onkologie und Gerinnung
Kronach, 96317, Germany
Onkologische Schwerpunktpraxis
Kronach, Germany
Studienzentrum UnterEms
Leer, Germany
Urologische Arztpraxis
Leipzig, Germany
Urologische Praxis
Luckenwalde, Germany
Universitätsklinikum Magdeburg
Magdeburg, 39120, Germany
Uniklinik Marburg
Marburg, Germany
Praxis für Urologie, Andrologie, Onkologie und medikamentöse Tumortherapie
Markkleeberg, 04416, Germany
Onkologische Praxis Moers
Moers, 47441, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063, Germany
Facharztpraxis für Hämatologie und Internistische Onkologie
München, 80331, Germany
LMU Urologische Klinik und Poliklinik
München, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Praxis Naunhof
Naunhof, Germany
Urologische Gemeinschaftspraxis
Neunkirchen, 66538, Germany
Praxis für Hämatologie und Internistische Onkologie
Neustadt am Rübenberge, 31535, Germany
Klinikum Nürnberg
Nuremberg, 90419, Germany
MVZ Urologie gGmbH
Nuremberg, Germany
Sana Klinikum Offenbach GmbH
Offenbach, Germany
MVZ Kreis Olpe
Olpe, 57462, Germany
Klinikum Osnabrück GmbH
Osnabrück, Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn, 33098, Germany
Urologische Praxis
Parchim, 19370, Germany
Urologie
Potsdam, Germany
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany
Elblandklinikum Riesa
Riesa, 01589, Germany
MVZ MP Saaletal
Saalfeld, 07318, Germany
Zentrum für Ambulante Onkologie
Schorndorf, 73614, Germany
Klinikum Sindelfingen-Böblingen
Sindelfingen, 71065, Germany
Klinikum Solingen
Solingen, Germany
Krankenhaus Torgau J. Kentmann gGmbH
Torgau, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, 54292, Germany
Medizinische Studiengesellschaft Nord-West GmbH
Westerstede, 26655, Germany
Praxisgemeinschaft für Onkologie und Urologie
Wilhelmshaven, 26389, Germany
GIM - Gemeinschaftspraxis Innere Medizin
Witten, 58455, Germany
Praxis Urologie Köpenick
Zwickau, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 27, 2018
Study Start
September 24, 2018
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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/).
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.