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.

Recruiting

• Conditions: Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

• Registration Number: NCT03647878
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Study Start: 2018-09-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs	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.
The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs	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.
The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)	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.
Number of injection delayed of nivolumab due to SAE/AE	2 years

Secondary Outcome Measures

Name	Time	Method
Impact of the activity level at baseline on the occurrence of adverse events (AEs)	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.
The proportion of subjects with termination due to SAEs/AEs in sub-group	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).
Best overall response - Overall Response Rate (ORR)	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.
The proportion of subjects with dose reduction due to SAEs/AEs in sub-group	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).
Progression free survival (PFS)	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.
Best overall response - Disease Control Rate (DCR)	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.
All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes	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.
The proportion of subjects with dose interruption due to SAEs/AEs in sub-group	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).

Trial Locations

Locations (82)

Landeskrankenhaus Hochsteiermark; 🇦🇹 Leoben, Austria

Ordensklinikum Linz GmbH; 🇦🇹 Linz, Austria

Kepler Universitätsklinikum GmbH; 🇦🇹 Linz, Austria

Uniklinikum Salzburg; 🇦🇹 Salzburg, Austria

Salzkammergutklinikum Vöcklabruck; 🇦🇹 Vöcklabruck, Austria

Klinikum Wels-Grieskirchen GmbH; 🇦🇹 Wels, Austria

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Urologisches Zentrum Euregio; 🇩🇪 Aachen, Germany

Onkologie aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Universitätsklinikum Augsburg A.ö.R; 🇩🇪 Augsburg, 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, Germany

GFO Kliniken Rhein-Berg; 🇩🇪 Bergisch Gladbach, Germany

Praxis für Urologie; 🇩🇪 Berlin, Germany

Onkologie am Segelfliegerdamm; 🇩🇪 Berlin, Germany

überörtl. Praxis für Urologie & Onkologie; 🇩🇪 Berlin, Germany

Praxis am Volkspark; 🇩🇪 Berlin, Germany

Praxis Urologie Köpenick; 🇩🇪 Zwickau, Germany

Urologische Praxis Berlin; 🇩🇪 Berlin, Germany

Vivantes Klinikum am Urban; 🇩🇪 Berlin, Germany

Zentrum für urologische Onkologie, Palliativmedizin und allgemeine Urologie; 🇩🇪 Berlin, Germany

Urologische Arztpraxis; 🇩🇪 Lutherstadt Eisleben, Germany

Franziskus Hospital Bielefeld; 🇩🇪 Bielefeld, Germany

Centrum für Operative Urologie; 🇩🇪 Bremen, Germany

Klinikum Bremen Mitte; 🇩🇪 Bremen, Germany

Edia.med MVZ; 🇩🇪 Chemnitz, Germany

Gemeinschaftspraxis für Urologie Cottbus; 🇩🇪 Cottbus, Germany

Onkologisches Zentrum Donauwörth; 🇩🇪 Donauwörth, Germany

Onkozentrum Dresden/Freiberg; 🇩🇪 Dresden, Germany

Urologische Gemeinschaftspraxis; 🇩🇪 Neunkirchen, Germany

Gemeinschaftspraxis Hämatologie-Onkologie, Dresden; 🇩🇪 Dresden, Germany

Fachzentrum für Urologie Eggenfelden; 🇩🇪 Eggenfelden, Germany

St. Georg Klinikum; 🇩🇪 Eisenach, Germany

Uniklinikum Erlangen; 🇩🇪 Erlangen, Germany

Markuskrankenhaus; 🇩🇪 Frankfurt am main, Germany

Gemeinschaftspraxis; 🇩🇪 Garbsen, Germany

Universitätsklinikum Gießen und Marburg GmbH; 🇩🇪 Gießen, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Krankenhaus Martha-Maria Halle-Dölau; 🇩🇪 Halle, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Evangelisches Krankenhaus Hamm gGmbH; 🇩🇪 Hamm, Germany

Onkologisches Studienzentrum am Raschplatz; 🇩🇪 Hannover, Germany

Immunologisch onkologisches MVZ; 🇩🇪 Hannover, Germany

Kreiskliniken Herford; 🇩🇪 Herford, Germany

Uniklinik Jena; 🇩🇪 Jena, Germany

Praxis für Hämatologie, Onkologie und Gerinnung; 🇩🇪 Kronach, Germany

Onkologische Schwerpunktpraxis; 🇩🇪 Kronach, Germany

Studienzentrum UnterEms; 🇩🇪 Leer, Germany

Urologische Praxis; 🇩🇪 Parchim, Germany

Universitätsklinikum Magdeburg; 🇩🇪 Magdeburg, Germany

Uniklinik Marburg; 🇩🇪 Marburg, Germany

Praxis für Urologie, Andrologie, Onkologie und medikamentöse Tumortherapie; 🇩🇪 Markkleeberg, Germany

Urologische Gemeischaftspraxis Hochsauerland; 🇩🇪 Meschede, Germany

Onkologische Praxis Moers; 🇩🇪 Moers, Germany

Kliniken Maria Hilf GmbH; 🇩🇪 Mönchengladbach, Germany

Facharztpraxis für Hämatologie und Internistische Onkologie; 🇩🇪 München, Germany

LMU Urologische Klinik und Poliklinik; 🇩🇪 München, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Praxis Naunhof; 🇩🇪 Naunhof, Germany

Praxis für Hämatologie und Internistische Onkologie; 🇩🇪 Neustadt Am Rübenberge, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

MVZ Urologie gGmbH; 🇩🇪 Nürnberg, Germany

Sana Klinikum Offenbach GmbH; 🇩🇪 Offenbach, Germany

MVZ Kreis Olpe; 🇩🇪 Olpe, Germany

Klinikum Osnabrück GmbH; 🇩🇪 Osnabrück, Germany

Brüderkrankenhaus St. Josef Paderborn; 🇩🇪 Paderborn, Germany

Urologie; 🇩🇪 Potsdam, Germany

Krankenhaus Barmherzige Brüder Regensburg; 🇩🇪 Regensburg, Germany

Elblandklinikum Riesa; 🇩🇪 Riesa, Germany

Wissenschaftskontor Nord GmbH &Co KG; 🇩🇪 Rostock, Germany

MVZ MP Saaletal; 🇩🇪 Saalfeld/Saale, Germany

Zentrum für Ambulante Onkologie; 🇩🇪 Schorndorf, Germany

Klinikum Sindelfingen-Böblingen; 🇩🇪 Sindelfingen, Germany

Klinikum Solingen; 🇩🇪 Solingen, Germany

Krankenhaus Torgau J. Kentmann gGmbH; 🇩🇪 Torgau, Germany

Krankenhaus der Barmherzigen Brüder Trier; 🇩🇪 Trier, Germany

Medizinische Studiengesellschaft Nord-West GmbH; 🇩🇪 Westerstede, Germany

Praxisgemeinschaft für Onkologie und Urologie; 🇩🇪 Wilhelmshaven, Germany

GIM - Gemeinschaftspraxis Innere Medizin; 🇩🇪 Witten, Germany

Onkologische Schwerpunktpraxis Wolfsburg; 🇩🇪 Wolfsburg, Germany