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.

NCT ID: NCT03647878

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-24

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Landeskrankenhaus Hochsteiermark

Leoben, , Austria

Site Status

Kepler Universitätsklinikum GmbH

Linz, , Austria

Site Status

Uniklinikum Salzburg

Salzburg, , Austria

Site Status

Salzkammergutklinikum Vöcklabruck

Vöcklabruck, , Austria

Site Status

Klinikum Wels-Grieskirchen GmbH

Wels, , Austria

Site Status

Universitätsklinikum Aachen

Aachen, , Germany

Site Status

Urologisches Zentrum Euregio

Aachen, , Germany

Site Status

Onkologie aschaffenburg

Aschaffenburg, , Germany

Site Status

Universitätsklinikum Augsburg A.ö.R

Augsburg, , Germany

Site Status

MVZ Taunus GmbH

Bad Homburg, , Germany

Site Status

Hämatologisch-Onkologische Schwerpunktpraxis

Bad Liebenwerda, , Germany

Site Status

Urologische Praxis Bad Schlema

Bad Schlema, , Germany

Site Status

Klinikum am Bruderwald Medizinische Klinik V

Bamberg, , Germany

Site Status

GFO Kliniken Rhein-Berg

Bergisch Gladbach, , Germany

Site Status

Praxis für Urologie

Berlin, , Germany

Site Status

Onkologie am Segelfliegerdamm

Berlin, , Germany

Site Status

Praxis am Volkspark

Berlin, , Germany

Site Status

Praxis Urologie Köpenick

Berlin, , Germany

Site Status

Urologische Praxis Berlin

Berlin, , Germany

Site Status

Vivantes Klinikum am Urban

Berlin, , Germany

Site Status

Zentrum für urologische Onkologie, Palliativmedizin und allgemeine Urologie

Berlin, , Germany

Site Status

Urologische Arztpraxis

Bernburg, , Germany

Site Status

Franziskus Hospital Bielefeld

Bielefeld, , Germany

Site Status

Centrum für Operative Urologie

Bremen, , Germany

Site Status

Klinikum Bremen Mitte

Bremen, , Germany

Site Status

Edia.med MVZ

Chemnitz, , Germany

Site Status

Gemeinschaftspraxis für Urologie Cottbus

Cottbus, , Germany

Site Status

Onkologisches Zentrum Donauwörth

Donauwörth, , Germany

Site Status

Onkozentrum Dresden/Freiberg

Dresden, , Germany

Site Status

Urologische Gemeinschaftspraxis

Dresden, , Germany

Site Status

Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

Dresden, , Germany

Site Status

Fachzentrum für Urologie Eggenfelden

Eggenfelden, , Germany

Site Status

St. Georg Klinikum

Eisenach, , Germany

Site Status

Urologische Arztpraxis

Eisleben Lutherstadt, , Germany

Site Status

Uniklinikum Erlangen

Erlangen, , Germany

Site Status

Markuskrankenhaus

Frankfurt am Main, , Germany

Site Status

Gemeinschaftspraxis

Garbsen, , Germany

Site Status

Universitätsklinikum Gießen und Marburg GmbH

Giessen, , Germany

Site Status

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status

Krankenhaus Martha-Maria Halle-Dölau

Halle, , Germany

Site Status

Asklepios Klinik Altona

Hamburg, , Germany

Site Status

Evangelisches Krankenhaus Hamm gGmbH

Hamm, , Germany

Site Status

Onkologisches Studienzentrum am Raschplatz

Hanover, , Germany

Site Status

Immunologisch onkologisches MVZ

Hanover, , Germany

Site Status

Kreiskliniken Herford

Herford, , Germany

Site Status

Uniklinik Jena

Jena, , Germany

Site Status

Praxis für Hämatologie, Onkologie und Gerinnung

Kronach, , Germany

Site Status

Onkologische Schwerpunktpraxis

Kronach, , Germany

Site Status

Studienzentrum UnterEms

Leer, , Germany

Site Status

Urologische Arztpraxis

Leipzig, , Germany

Site Status

Urologische Praxis

Luckenwalde, , Germany

Site Status

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Site Status

Uniklinik Marburg

Marburg, , Germany

Site Status

Praxis für Urologie, Andrologie, Onkologie und medikamentöse Tumortherapie

Markkleeberg, , Germany

Site Status

Onkologische Praxis Moers

Moers, , Germany

Site Status

Kliniken Maria Hilf GmbH

Mönchengladbach, , Germany

Site Status

Facharztpraxis für Hämatologie und Internistische Onkologie

München, , Germany

Site Status

LMU Urologische Klinik und Poliklinik

München, , Germany

Site Status

Universitätsklinikum Münster

Münster, , Germany

Site Status

Praxis Naunhof

Naunhof, , Germany

Site Status

Urologische Gemeinschaftspraxis

Neunkirchen, , Germany

Site Status

Praxis für Hämatologie und Internistische Onkologie

Neustadt am Rübenberge, , Germany

Site Status

Klinikum Nürnberg

Nuremberg, , Germany

Site Status

MVZ Urologie gGmbH

Nuremberg, , Germany

Site Status

Sana Klinikum Offenbach GmbH

Offenbach, , Germany

Site Status

MVZ Kreis Olpe

Olpe, , Germany

Site Status

Klinikum Osnabrück GmbH

Osnabrück, , Germany

Site Status

Brüderkrankenhaus St. Josef Paderborn

Paderborn, , Germany

Site Status

Urologische Praxis

Parchim, , Germany

Site Status

Urologie

Potsdam, , Germany

Site Status

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, , Germany

Site Status

Elblandklinikum Riesa

Riesa, , Germany

Site Status

MVZ MP Saaletal

Saalfeld, , Germany

Site Status

Zentrum für Ambulante Onkologie

Schorndorf, , Germany

Site Status

Klinikum Sindelfingen-Böblingen

Sindelfingen, , Germany

Site Status

Klinikum Solingen

Solingen, , Germany

Site Status

Krankenhaus Torgau J. Kentmann gGmbH

Torgau, , Germany

Site Status

Krankenhaus der Barmherzigen Brüder Trier

Trier, , Germany

Site Status

Medizinische Studiengesellschaft Nord-West GmbH

Westerstede, , Germany

Site Status

Praxisgemeinschaft für Onkologie und Urologie

Wilhelmshaven, , Germany

Site Status

GIM - Gemeinschaftspraxis Innere Medizin

Witten, , Germany

Site Status

Praxis Urologie Köpenick

Zwickau, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A-DE-60000-009

Identifier Type: -

Identifier Source: org_study_id