A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults

Study Overview
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Brief Summary
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The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.

Official Title
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A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults

Conditions
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Advanced Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with diagnosis of aRCC with clear-cell component Participants with no prior systemic treatment for aRCC with clear-cell component; Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels; Exclusion Criteria: Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study; History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.

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 |
| --- | --- | --- |
| Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab. |  | At 18 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor median progression-free survival (PFS) time | Including clinical and radiographic assessments defined as the time between the start date of cabozantinib in combination with nivolumab and the date of progression or death of any cause. The Kaplan-Meier method will be used to estimate median PFS. | Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression | 
| Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR)) | Assessed by the investigator | Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression | 
| Duration of response (DOR) | Defined as the interval from the date of first response (complete or partial) to treatment with cabozantinib in combination with nivolumab, to progressive disease or death | Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression | 
| Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)). |  | Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression. | 
| Time of response (TTR) | Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial). | Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression | 
| Pattern of use of cabozantinib under real-world practice conditions. |  | Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression | 
| Pattern of use of nivolumab under real-world practice conditions. |  | Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression | 
| Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs). | All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC. | Up to 42 months or disease progression | 
| Change in disease-related symptoms | Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire | Change from baseline at each visit up to 42 months | 
| Change in pain | Assessed by the Numerical Pain Rating Scale (NPRS) | Change from baseline at each visit up to 42 months | 
| Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation | Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line | Up to 42 months. |