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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03647878




Registration number
NCT03647878
Ethics application status
Date submitted
25/07/2018
Date registered
27/08/2018

Titles & IDs
Public title
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.
Scientific 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
Secondary ID [1] 0 0
A-DE-60000-009
Universal Trial Number (UTN)
Trial acronym
CABOCARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Renal Cell Carcinoma 0 0
Metastatic Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
Number of injection delayed of nivolumab due to SAE/AE
Timepoint [4] 0 0
2 years
Secondary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Best overall response - Overall Response Rate (ORR)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Best overall response - Disease Control Rate (DCR)
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Impact of the activity level at baseline on the occurrence of adverse events (AEs)
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
The proportion of subjects with termination due to SAEs/AEs in sub-group
Timepoint [6] 0 0
2 year
Secondary outcome [7] 0 0
The proportion of subjects with dose interruption due to SAEs/AEs in sub-group
Timepoint [7] 0 0
2 year
Secondary outcome [8] 0 0
The proportion of subjects with dose reduction due to SAEs/AEs in sub-group
Timepoint [8] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Leoben
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
Vöcklabruck
Country [5] 0 0
Austria
State/province [5] 0 0
Wels
Country [6] 0 0
Germany
State/province [6] 0 0
Aachen
Country [7] 0 0
Germany
State/province [7] 0 0
Aschaffenburg
Country [8] 0 0
Germany
State/province [8] 0 0
Augsburg
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Homburg
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Liebenwerda
Country [11] 0 0
Germany
State/province [11] 0 0
Bad Schlema
Country [12] 0 0
Germany
State/province [12] 0 0
Bamberg
Country [13] 0 0
Germany
State/province [13] 0 0
Bergisch Gladbach
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Bernburg
Country [16] 0 0
Germany
State/province [16] 0 0
Bielefeld
Country [17] 0 0
Germany
State/province [17] 0 0
Bremen
Country [18] 0 0
Germany
State/province [18] 0 0
Chemnitz
Country [19] 0 0
Germany
State/province [19] 0 0
Cottbus
Country [20] 0 0
Germany
State/province [20] 0 0
Donauwörth
Country [21] 0 0
Germany
State/province [21] 0 0
Dresden
Country [22] 0 0
Germany
State/province [22] 0 0
Eggenfelden
Country [23] 0 0
Germany
State/province [23] 0 0
Eisenach
Country [24] 0 0
Germany
State/province [24] 0 0
Erlangen
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt am main
Country [26] 0 0
Germany
State/province [26] 0 0
Garbsen
Country [27] 0 0
Germany
State/province [27] 0 0
Gießen
Country [28] 0 0
Germany
State/province [28] 0 0
Göttingen
Country [29] 0 0
Germany
State/province [29] 0 0
Halle
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Hamm
Country [32] 0 0
Germany
State/province [32] 0 0
Hannover
Country [33] 0 0
Germany
State/province [33] 0 0
Herford
Country [34] 0 0
Germany
State/province [34] 0 0
Jena
Country [35] 0 0
Germany
State/province [35] 0 0
Kronach
Country [36] 0 0
Germany
State/province [36] 0 0
Leer
Country [37] 0 0
Germany
State/province [37] 0 0
Leipzig
Country [38] 0 0
Germany
State/province [38] 0 0
Luckenwalde
Country [39] 0 0
Germany
State/province [39] 0 0
Lutherstadt Eisleben
Country [40] 0 0
Germany
State/province [40] 0 0
Magdeburg
Country [41] 0 0
Germany
State/province [41] 0 0
Marburg
Country [42] 0 0
Germany
State/province [42] 0 0
Markkleeberg
Country [43] 0 0
Germany
State/province [43] 0 0
Meschede
Country [44] 0 0
Germany
State/province [44] 0 0
Moers
Country [45] 0 0
Germany
State/province [45] 0 0
Mönchengladbach
Country [46] 0 0
Germany
State/province [46] 0 0
München
Country [47] 0 0
Germany
State/province [47] 0 0
Münster
Country [48] 0 0
Germany
State/province [48] 0 0
Naunhof
Country [49] 0 0
Germany
State/province [49] 0 0
Neunkirchen
Country [50] 0 0
Germany
State/province [50] 0 0
Neustadt Am Rübenberge
Country [51] 0 0
Germany
State/province [51] 0 0
Nürnberg
Country [52] 0 0
Germany
State/province [52] 0 0
Offenbach
Country [53] 0 0
Germany
State/province [53] 0 0
Olpe
Country [54] 0 0
Germany
State/province [54] 0 0
Osnabrück
Country [55] 0 0
Germany
State/province [55] 0 0
Paderborn
Country [56] 0 0
Germany
State/province [56] 0 0
Parchim
Country [57] 0 0
Germany
State/province [57] 0 0
Potsdam
Country [58] 0 0
Germany
State/province [58] 0 0
Regensburg
Country [59] 0 0
Germany
State/province [59] 0 0
Riesa
Country [60] 0 0
Germany
State/province [60] 0 0
Rostock
Country [61] 0 0
Germany
State/province [61] 0 0
Saalfeld/Saale
Country [62] 0 0
Germany
State/province [62] 0 0
Schorndorf
Country [63] 0 0
Germany
State/province [63] 0 0
Sindelfingen
Country [64] 0 0
Germany
State/province [64] 0 0
Solingen
Country [65] 0 0
Germany
State/province [65] 0 0
Torgau
Country [66] 0 0
Germany
State/province [66] 0 0
Trier
Country [67] 0 0
Germany
State/province [67] 0 0
Westerstede
Country [68] 0 0
Germany
State/province [68] 0 0
Wilhelmshaven
Country [69] 0 0
Germany
State/province [69] 0 0
Witten
Country [70] 0 0
Germany
State/province [70] 0 0
Wolfsburg
Country [71] 0 0
Germany
State/province [71] 0 0
Zwickau

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ipsen Recruitment Enquiries
Address 0 0
Country 0 0
Phone 0 0
see email address
Fax 0 0
Email 0 0
clinical.trials@ipsen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
When will data be available (start and end dates)?
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03647878