Clinical trial NCT03647878: 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.
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)
timeFrame: 2 years
measure: The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs
timeFrame: 2 years
measure: The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs
timeFrame: 2 years
measure: Number of injection delayed of nivolumab due to SAE/AE
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Best overall response - Overall Response Rate (ORR)
timeFrame: 2 years
measure: Best overall response - Disease Control Rate (DCR)
timeFrame: 2 years
measure: All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes
timeFrame: 2 years
measure: Impact of the activity level at baseline on the occurrence of adverse events (AEs)
timeFrame: 2 years
measure: The proportion of subjects with termination due to SAEs/AEs in sub-group
timeFrame: 2 year
measure: The proportion of subjects with dose interruption due to SAEs/AEs in sub-group
timeFrame: 2 year
measure: The proportion of subjects with dose reduction due to SAEs/AEs in sub-group
timeFrame: 2 years
Other outcomes:
Locations:
city: Leoben
country: Austria
facility: Landeskrankenhaus Hochsteiermark
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Vöcklabruck
country: Austria
facility: Salzkammergutklinikum Vöcklabruck
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Aachen
country: Germany
facility: Urologisches Zentrum Euregio
city: Aschaffenburg
country: Germany
facility: Onkologie aschaffenburg
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg A.ö.R
city: Bad Homburg
country: Germany
facility: MVZ Taunus GmbH
city: Bad Liebenwerda
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis
city: Bad Schlema
country: Germany
facility: Urologische Praxis Bad Schlema
city: Bamberg
country: Germany
facility: Klinikum am Bruderwald Medizinische Klinik V
city: Bergisch Gladbach
country: Germany
facility: GFO Kliniken Rhein-Berg
city: Berlin
country: Germany
facility: Praxis für Urologie
city: Berlin
country: Germany
facility: Onkologie am Segelfliegerdamm
city: Berlin
country: Germany
facility: Praxis am Volkspark
city: Berlin
country: Germany
facility: Praxis Urologie Köpenick
city: Berlin
country: Germany
facility: Urologische Praxis Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Zentrum für urologische Onkologie, Palliativmedizin und allgemeine Urologie
city: Bernburg
country: Germany
facility: Urologische Arztpraxis
city: Bielefeld
country: Germany
facility: Franziskus Hospital Bielefeld
city: Bremen
country: Germany
facility: Centrum für Operative Urologie
city: Bremen
country: Germany
facility: Klinikum Bremen Mitte
city: Chemnitz
country: Germany
facility: Edia.med MVZ
city: Cottbus
country: Germany
facility: Gemeinschaftspraxis für Urologie Cottbus
city: Donauwörth
country: Germany
facility: Onkologisches Zentrum Donauwörth
city: Dresden
country: Germany
facility: Onkozentrum Dresden/Freiberg
city: Dresden
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie-Onkologie, Dresden
city: Eggenfelden
country: Germany
facility: Fachzentrum für Urologie Eggenfelden
city: Eisenach
country: Germany
facility: St. Georg Klinikum
city: Erlangen
country: Germany
facility: Uniklinikum Erlangen
city: Frankfurt am main
country: Germany
facility: Markuskrankenhaus
city: Garbsen
country: Germany
facility: Gemeinschaftspraxis
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm gGmbH
city: Hannover
country: Germany
facility: Onkologisches Studienzentrum am Raschplatz
city: Hannover
country: Germany
facility: Immunologisch onkologisches MVZ
city: Herford
country: Germany
facility: Kreiskliniken Herford
city: Jena
country: Germany
facility: Uniklinik Jena
city: Kronach
country: Germany
facility: Praxis für Hämatologie, Onkologie und Gerinnung
city: Kronach
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Leer
country: Germany
facility: Studienzentrum UnterEms
city: Leipzig
country: Germany
facility: Urologische Arztpraxis
city: Luckenwalde
country: Germany
facility: Urologische Praxis
city: Lutherstadt Eisleben
country: Germany
facility: Urologische Arztpraxis
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Marburg
country: Germany
facility: Uniklinik Marburg
city: Markkleeberg
country: Germany
facility: Praxis für Urologie, Andrologie, Onkologie und medikamentöse Tumortherapie
city: Moers
country: Germany
facility: Onkologische Praxis Moers
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: München
country: Germany
facility: Facharztpraxis für Hämatologie und Internistische Onkologie
city: München
country: Germany
facility: LMU Urologische Klinik und Poliklinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Naunhof
country: Germany
facility: Praxis Naunhof
city: Neunkirchen
country: Germany
facility: Urologische Gemeinschaftspraxis
city: Neustadt Am Rübenberge
country: Germany
facility: Praxis für Hämatologie und Internistische Onkologie
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Nürnberg
country: Germany
facility: MVZ Urologie gGmbH
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH
city: Olpe
country: Germany
facility: MVZ Kreis Olpe
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef Paderborn
city: Parchim
country: Germany
facility: Urologische Praxis
city: Potsdam
country: Germany
facility: Urologie
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
city: Riesa
country: Germany
facility: Elblandklinikum Riesa
city: Saalfeld/Saale
country: Germany
facility: MVZ MP Saaletal
city: Schorndorf
country: Germany
facility: Zentrum für Ambulante Onkologie
city: Sindelfingen
country: Germany
facility: Klinikum Sindelfingen-Böblingen
city: Solingen
country: Germany
facility: Klinikum Solingen
city: Torgau
country: Germany
facility: Krankenhaus Torgau J. Kentmann gGmbH
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Westerstede
country: Germany
facility: Medizinische Studiengesellschaft Nord-West GmbH
city: Wilhelmshaven
country: Germany
facility: Praxisgemeinschaft für Onkologie und Urologie
city: Witten
country: Germany
facility: GIM - Gemeinschaftspraxis Innere Medizin
city: Zwickau
country: Germany
facility: Praxis Urologie Köpenick
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: