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.
1. The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs) (Time Frame - 2 years): 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. The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs (Time Frame - 2 years): The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.
3. The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs (Time Frame - 2 years): The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.
4. Number of injection delayed of nivolumab due to SAE/AE (Time Frame - 2 years)
Secondary outcome:
1. Progression free survival (PFS) (Time Frame - 2 years): 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. Best overall response - Overall Response Rate (ORR) (Time Frame - 2 years): 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.
3. Best overall response - Disease Control Rate (DCR) (Time Frame - 2 years): 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.
4. All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes (Time Frame - 2 years): 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.
5. Impact of the activity level at baseline on the occurrence of adverse events (AEs) (Time Frame - 2 years): 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.
6. The proportion of subjects with termination due to SAEs/AEs in sub-group (Time Frame - 2 year): 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).
7. The proportion of subjects with dose interruption due to SAEs/AEs in sub-group (Time Frame - 2 year): 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).
8. The proportion of subjects with dose reduction due to SAEs/AEs in sub-group (Time Frame - 2 years): 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).
Quelle: ClinicalTrials.gov
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"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."
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