AzTrials
AzTrials

Advanced Renal Cell CarcinomaCABOCARENCT03647878

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.

An observational study of Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Ipsen at 82 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
224 participants
Where
82 sitesin 2 countries
Study dates
24 Sep 2018to 30 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated with Cabozantinib as monotherapy or in combination with nivolumab in advanced or metastatic renal cell carcinoma in 1st line treatment

Who may be able to join

  • 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

Who cannot join

  • Participation in an interventional study at the same time and/or within 3 months before baseline.
  • Previous participation in this study

Trial locations and contacts

82 sites in 2 countries.

82 sites in 2 countries

Germany77 sites

  • Universitätsklinikum Aachen

    Aachen

  • Urologisches Zentrum Euregio

    Aachen

  • Onkologie aschaffenburg

    Aschaffenburg, 63739

  • Universitätsklinikum Augsburg A.ö.R

    Augsburg, 86156

  • MVZ Taunus GmbH

    Bad Homburg

  • Hämatologisch-Onkologische Schwerpunktpraxis

    Bad Liebenwerda

  • Urologische Praxis Bad Schlema

    Bad Schlema

  • Klinikum am Bruderwald Medizinische Klinik V

    Bamberg, 96049

  • GFO Kliniken Rhein-Berg

    Bergisch Gladbach

  • Praxis für Urologie

    Berlin, 12099

  • Onkologie am Segelfliegerdamm

    Berlin, 12487

  • Praxis am Volkspark

    Berlin

  • Praxis Urologie Köpenick

    Berlin

  • Urologische Praxis Berlin

    Berlin

  • Vivantes Klinikum am Urban

    Berlin

  • Zentrum für urologische Onkologie, Palliativmedizin und allgemeine Urologie

    Berlin

  • Urologische Arztpraxis

    Bernburg

  • Franziskus Hospital Bielefeld

    Bielefeld, 33615

  • Centrum für Operative Urologie

    Bremen, 28277

  • Klinikum Bremen Mitte

    Bremen

  • Edia.med MVZ

    Chemnitz, 09130

  • Gemeinschaftspraxis für Urologie Cottbus

    Cottbus

  • Onkologisches Zentrum Donauwörth

    Donauwörth, 86609

  • Onkozentrum Dresden/Freiberg

    Dresden, 01127

  • Urologische Gemeinschaftspraxis

    Dresden, 01307

  • Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

    Dresden

  • Fachzentrum für Urologie Eggenfelden

    Eggenfelden

  • St. Georg Klinikum

    Eisenach, 99817

  • Urologische Arztpraxis

    Eisleben Lutherstadt, 06295

  • Uniklinikum Erlangen

    Erlangen

  • Markuskrankenhaus

    Frankfurt am Main

  • Gemeinschaftspraxis

    Garbsen, 30823

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle

  • Asklepios Klinik Altona

    Hamburg

  • Evangelisches Krankenhaus Hamm gGmbH

    Hamm, 59063

  • Onkologisches Studienzentrum am Raschplatz

    Hanover, 30161

  • Immunologisch onkologisches MVZ

    Hanover, 30449

  • Kreiskliniken Herford

    Herford

  • Uniklinik Jena

    Jena

  • Praxis für Hämatologie, Onkologie und Gerinnung

    Kronach, 96317

  • Onkologische Schwerpunktpraxis

    Kronach

  • Studienzentrum UnterEms

    Leer

  • Urologische Arztpraxis

    Leipzig

  • Urologische Praxis

    Luckenwalde

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Uniklinik Marburg

    Marburg

  • Praxis für Urologie, Andrologie, Onkologie und medikamentöse Tumortherapie

    Markkleeberg, 04416

  • Onkologische Praxis Moers

    Moers, 47441

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Facharztpraxis für Hämatologie und Internistische Onkologie

    München, 80331

  • LMU Urologische Klinik und Poliklinik

    München

  • Universitätsklinikum Münster

    Münster, 48149

  • Praxis Naunhof

    Naunhof

  • Urologische Gemeinschaftspraxis

    Neunkirchen, 66538

  • Praxis für Hämatologie und Internistische Onkologie

    Neustadt am Rübenberge, 31535

  • Klinikum Nürnberg

    Nuremberg, 90419

  • MVZ Urologie gGmbH

    Nuremberg

  • Sana Klinikum Offenbach GmbH

    Offenbach

  • MVZ Kreis Olpe

    Olpe, 57462

  • Klinikum Osnabrück GmbH

    Osnabrück

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098

  • Urologische Praxis

    Parchim, 19370

  • Urologie

    Potsdam

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg

  • Elblandklinikum Riesa

    Riesa, 01589

  • MVZ MP Saaletal

    Saalfeld, 07318

  • Zentrum für Ambulante Onkologie

    Schorndorf, 73614

  • Klinikum Sindelfingen-Böblingen

    Sindelfingen, 71065

  • Klinikum Solingen

    Solingen

  • Krankenhaus Torgau J. Kentmann gGmbH

    Torgau

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

  • Medizinische Studiengesellschaft Nord-West GmbH

    Westerstede, 26655

  • Praxisgemeinschaft für Onkologie und Urologie

    Wilhelmshaven, 26389

  • GIM - Gemeinschaftspraxis Innere Medizin

    Witten, 58455

  • Praxis Urologie Köpenick

    Zwickau

Other trials in Germany

Austria5 sites

  • Landeskrankenhaus Hochsteiermark

    Leoben, A-8700

  • Kepler Universitätsklinikum GmbH

    Linz, 4021

  • Uniklinikum Salzburg

    Salzburg, A-5020

  • Salzkammergutklinikum Vöcklabruck

    Vöcklabruck, A-4840

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

About this study

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

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.

Medical subject headings
Carcinoma, Renal Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. Number of injection delayed of nivolumab due to SAE/AE

    Measured: 2 years

Secondary outcomes (8)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 2 years

  5. 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.

    Measured: 2 years

  6. 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).

    Measured: 2 year

  7. 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).

    Measured: 2 year

  8. 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).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start24 Sep 2018
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647878
Sponsor's protocol ID
A-DE-60000-009
Acronym
CABOCARE
Status last verified
Sep 2026
First submitted
25 Jul 2018
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Ipsen at 82 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03647878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in