CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study

Study Overview
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Brief Summary
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This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.

Official Title
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Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study

Conditions
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Advanced Renal Cell Carcinoma (All Subtypes), Metastatic Renal Cell Carcinoma (All Subtypes)

Intervention / Treatment
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* Other: Documentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject Patients with advanced or metastatic renal cell carcinoma, including all subtypes Age ≥ 18 years Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment Exclusion Criteria: Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)

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

| Intervention/Treatment |
| --- |
|Other: Documentation|Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events | Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of dose reductions | number of dose reductions | through study completion, an average of 1 year | 
| number of dose interruptions | number of dose interruptions | through study completion, an average of 1 year | 
| number of terminations of cabozantinib treatment due to adverse events | number of terminations of cabozantinib treatment due to adverse events | through study completion, an average of 1 year | 
| ORR | ORR (investigator assessed; acc. RECIST v1.1 if available) | through study completion, an average of 1 year | 
| Clinical benefit rate (CBR) | Clinical benefit rate (CBR) | through study completion, an average of 1 year | 
| Duration of response | Duration of response in months | through study completion, an average of 1 year | 
| Duration of cabozantinib treatment | Duration of cabozantinib treatment in months | through study completion, an average of 1 year | 
| Time to next treatment | Time to next treatment in months | From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months | 
| Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data | Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data | through study completion, an average of 1 year | 
| Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR) | Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR) | through study completion, an average of 1 year |