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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Number of injection delayed of nivolumab due to SAE/AE |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |