Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)

Study Overview
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Brief Summary
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The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)

Official Title
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REPLICA: Real Patient Life Treatment With Cabozantinib in Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic RCC: a Descriptive and Prospective Non Interventional Study.

Conditions
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Advanced or 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 Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study Provision of written informed consent Exclusion Criteria: Participation in another interventional clinical study at the same time Previous participation in this clinical 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1st line<br> | |
| 2nd line<br> | |
| later lines<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment line | Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment. | Baseline | 
| Dose reductions and reasons | Number of dose reductions and reason | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | 
| Treatment interruptions and reason | Number of treatment interruptions and reason | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | 
| Treatment discontinuations and reason | Number of patients with permanent discontinuation and reason | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | 
| Alternative dose schedule | Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period | From baseline until the end of study up to 9 months | 
| Mean number of any dose modification |  | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | 
| Median number of any dose modification |  | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | 
| Median time to any first dose modification |  | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | 
| Median time to end of treatment |  | From baseline until the end of study up to 9 months | 
| Duration of treatment exposure |  | From baseline until the end of study up to 9 months | 
| Dose prescribed at initiation | Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline | Baseline | 
| Average daily dose | Estimation of average daily dose received by subject during the treatment exposure | From baseline until the end of study up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life score | Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates. | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | 
| Progression Free Survival (PFS) | Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib | From baseline until the end of study up to 9 months | 
| Objective Response Rate | Percent of patients with partial and complete response during the treatment with cabozantinib | From baseline until the end of study up to 9 months | 
| Disease Control Rate | Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib | From baseline until the end of study up to 9 months |