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.

Metastatic Renal Cell Carcinoma Clinical Trial

— CABOCARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647878
• Other study ID #: A-DE-60000-009
• Status: Recruiting
• Start date: September 24, 2018
• Est. completion date: September 30, 2027

Study information

• Verified date: April 2024
• Source: Ipsen
• Contact: Ipsen Recruitment Enquiries
• Phone: see email address
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Hochsteiermark	Leoben
Austria	Kepler Universitätsklinikum GmbH	Linz
Austria	Ordensklinikum Linz GmbH	Linz
Austria	Uniklinikum Salzburg	Salzburg
Austria	Salzkammergutklinikum Vöcklabruck	Vöcklabruck
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Germany	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	Onkologie am Segelfliegerdamm	Berlin
Germany	Praxis am Volkspark	Berlin
Germany	Praxis für Urologie	Berlin
Germany	Praxis Urologie Köpenick	Berlin
Germany	überörtl. Praxis für Urologie & Onkologie	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
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	Gemeinschaftspraxis Hämatologie-Onkologie, Dresden	Dresden
Germany	Onkozentrum Dresden/Freiberg	Dresden
Germany	Urologische Gemeinschaftspraxis	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	Immunologisch onkologisches MVZ	Hannover
Germany	Onkologisches Studienzentrum am Raschplatz	Hannover
Germany	Kreiskliniken Herford	Herford
Germany	Uniklinik Jena	Jena
Germany	Onkologische Schwerpunktpraxis	Kronach
Germany	Praxis für Hämatologie, Onkologie und Gerinnung	Kronach
Germany	Studienzentrum UnterEms	Leer
Germany	Urologische Arztpraxis	Leipzig
Germany	Urologische Praxis	Luckenwalde
Germany	Urologische Arztpraxis	Lutherstadt Eisleben
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	Urologische Gemeinschaftspraxis	Neunkirchen
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	Urologische Praxis	Parchim
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	Praxis Urologie Köpenick	Zwickau

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of injection delayed of nivolumab due to SAE/AE		2 years
Secondary	Progression free survival (PFS)	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
Secondary	Best overall response - Overall Response Rate (ORR)	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
Secondary	Best overall response - Disease Control Rate (DCR)	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
Secondary	All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes	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
Secondary	Impact of the activity level at baseline on the occurrence of adverse events (AEs)	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
Secondary	The proportion of subjects with termination due to SAEs/AEs in sub-group	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
Secondary	The proportion of subjects with dose interruption due to SAEs/AEs in sub-group	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
Secondary	The proportion of subjects with dose reduction due to SAEs/AEs in sub-group	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