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

Bristol-Myers Squibb623 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

623

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival (OS)

By Cohort

Time frame: Up to 3 years

Secondary Outcomes

Overall Survival (OS)

Time frame: Up to 3 years

Progression Free Survival (PFS)

Time frame: Up to 3 years

Overall Response Rate (ORR)

Time frame: Up to 3 years

Best Overall Response Rate (BORR)

Time frame: Up to 3 years

Best Overall Response (BOR)

Time frame: Up to 3 years

Distribution of socio-demographic characteristics of participants