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NCT03647878 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 24, 2018
Est. completion date September 30, 2027

Study information
Verified date May 2024
Source Ipsen
Contact Ipsen Recruitment Enquiries
Phone see email address
Email clinical.trials@ipsen.com
Is FDA regulated No
Health authority
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.

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Study Design

Related Conditions & MeSH terms

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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
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