A Study to Learn About the First and Later Lines of Medicines in Treating People With Metastatic Renal Cell Carcinoma (mRCC).

Study Overview
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Brief Summary
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The purpose of this study is to learn about the effectiveness of the first and later lines of medicines on clinical outcomes in people with mRCC. The study includes participants who: are 18 years old or above and have mRCC took medicines that use the bodies immunity to fight against cancer as their first choice of treatment took other medicines after taking the above first choice of treatment This is a study that looks into the data collected through a particular database from selected academic clinical sites participating in this study. The data of interest include: the length of time between the start of a patient's treatment and the end of treatment the length of time between the start of treatment and death physician assessment of a patient's response to treatment We will compare the experiences of people receiving different combinations of treatments and see if there are any differences in the effectiveness of these medicines.

Official Title
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Clinical Effectiveness of First-Line Immuno-oncology (IO) Combination Treatment and Subsequent Lines of Therapy in Patients With Metastatic Renal Cell Carcinoma (mRCC) in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)

Conditions
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Metastatic Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with mRCC Age 18 years or over at the time of mRCC diagnosis Received IO combination treatment in 1L such as receiving ipilimumab + nivolumab or an axitinib-based regimen (ie, axitinib + pembrolizumab or axitinib + avelumab) as 1L Received subsequent treatments following 1L (e.g., 2L, 3L) Actively treated at an IMDC clinical center (to avoid incomplete data) Exclusion Criteria: - There are no exclusion criteria for this 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 |
| --- | --- |
| Patients with mRCC<br>Patients with mRCC in the IMDC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographical characteristics | Gender Age at time of 1L initiation Race Region indicator (i.e., US vs. ex-US) | From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months) | 
| Date of mRCC diagnosis |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Prior nephrectomy status |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Date of nephrectomy (if applicable) |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Tumor characteristics | Histology type (i.e., clear cell vs. non-clear cell RCC) Number of metastatic sites (e.g., 1 site or more than 1 site) Site of metastases (e.g., brain, bone, lung) | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| IMDC risk score | Assessed on index date and at initiation of each LOT | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Number of lines of therapy received by each patient |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Treatment agents received at each line of therapy |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Duration of each line of therapy |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Time from discontinuation of previous line of therapy to initiation of subsequent line of therapy |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Reason for discontinuation for each line of therapy |  | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Time to treatment discontinuation (TTD) | Defined as the time from treatment initiation to discontinuation of each therapy due to any reason including progression, death, or toxicity | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Time to next treatment (TTNT) | Defined as time from the initiation of 1L treatment to initiation of subsequent therapy or death | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Physician-assessed best response | Overall best response rate (complete or partial) Stable disease Progressive disease | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 
| Overall survival | Defined as the time between initiation of 1L IO combination therapy to death | From Time of Initiation of 1L IO combination therapy to death (up to 60 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney cancer, Metastatic renal cell carcinoma (mRCC), International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), Immunotherapy.