Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors

Study Overview
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Brief Summary
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To understand the epidemiology, treatment patterns and outcomes of patients with metastatic Renal Cell Carcinoma (mRCC). Data from mRCC patients who received cabozantinib versus non-cabozantinib Tyrosine Kinase Inhibitor (TKI) (a type of targeted cancer drug) immediately after Check Point Inhibitor (CPI) treatment (a type of immunotherapy that blocks proteins that stop the immune system from attacking the cancer cells) in US community oncology practices will be analyzed.

Official Title
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Non - Interventional, Retrospective Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors

Conditions
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Locally Advanced or Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Cabozantinib monotherapy
* Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of metastatic Renal Cell Carcinoma (mRCC) during the study period (May 01, 2016 to March 31, 2020); Patients who received cabozantinib or non-cabozantinib TKI regimens during identification period (May 01, 2016 to September 30, 2019); Patients who received CPIs, as monotherapy, or in combination with a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor (e.g. ipilimumab+nivolumab), as the latest treatment for mRCC administrated before cabozantinib or other TKI therapy; Patients ≥ 18 years of age as of their index date Patients who received care at a US Oncology Network site Patients with ≥ 2 visits within the US Oncology Network. Exclusion Criteria: Patients enrolled in a clinical trial at any time during index period Patients receiving treatment for another documented primary cancer diagnoses during the study period

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 |
| --- | --- |
| cabozantinib arm<br> | Drug: Cabozantinib monotherapy<br>* Intervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).<br>* Other names: Cabometyx;|
| non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm<br> | Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC<br>* As per authorized FDA label in advanced RCC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months Real-World Response Rate |  | From start of index treatment until 6 months of follow up or end of the treatment or death whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-World Overall Response Rate |  | From start of index treatment until end of the treatment or death whichever occurs first | 
| Overall Survival |  | From start of index treatment until death or end of the study whichever occurs first | 
| Real-World Duration of Response |  | From date of index treatment response and the earliest date of progressive disease | 
| Real-World Progression Free Survival |  | From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease | 
| Time to treatment discontinuation |  | From start of index treatment until treatment discontinuation | 
| Treatment dose reductions | Number of patients who had dose reduction/change as compared to the starting dose during index period | From start of index treatment until treatment discontinuation | 
| Treatment duration |  | From start of index treatment until treatment discontinuation | 
| Rate of hospitalisations | Number of patients who had been hospitalized (with reason of hospitalization when available) | From start of index treatment until treatment discontinuation | 
| Drug discontinuation due to its toxicity | Number of patients discontinuing index regimens due to its toxicity | From start of index treatment until treatment discontinuation (through study completion) |