Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer

Study Overview
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Brief Summary
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This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.

Official Title
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A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) With or Without Ipilimumab (BMS-734016) in Patients With Advanced Renal Cell Carcinoma in Real Life Setting

Conditions
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Renal Cell Carcinoma, Renal Cell Cancer, Adenocarcinoma Of Kidney, Adenocarcinoma, Renal Cell, Kidney Cancer, Cancer of the Kidney

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Adult participants with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of RCC, according to the label approved in France NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC Exclusion Criteria: Primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment Previously treated with anti-PD1, anti-programmed death-ligand 1 (anti-PDL1) or anti-CTLA4 therapy Currently included in an interventional clinical trial for advanced or RCC. Participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled Pregnant women and participants under guardianship

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 |
| --- | --- |
| Cohort 1: Nivolumab<br>Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC | |
| Cohort 2: Nivolumab + Ipilimumab<br>Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | By Cohort | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 3 years | 
| Progression Free Survival (PFS) |  | Up to 3 years | 
| Overall Response Rate (ORR) |  | Up to 3 years | 
| Best Overall Response Rate (BORR) |  | Up to 3 years | 
| Best Overall Response (BOR) |  | Up to 3 years | 
| Distribution of socio-demographic characteristics of participants |  | Approximately 3 years | 
| Distribution of clinical characteristics of participants |  | Approximately 3 years | 
| Distribution of management of participants with treatment-related adverse events (AEs) |  | Approximately 3 years | 
| Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score |  | At baseline | 
| Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score |  | At baseline | 
| Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC) |  | Approximately 3 years | 
| Distribution of incidence of AEs |  | Approximately 3 years | 
| Distribution of Severity of AEs |  | Approximately 3 years | 
| Distribution of management of AEs |  | Approximately 3 years | 
| Health-related quality of life of participants using Functional Assessment of Cancer Therapy -Kidney Symptom Index (FKSI-19) questionnaires | The FKSI-19 will be graded by the patient on a scale from 0 to 4 (range not at all to very much) | Approximately 3 years | 
| Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires | The EQ-5D descriptive system consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, each with 3 levels (eg, no problems, moderate problems, extreme problems) | Approximately 3 years |