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

Bristol-Myers Squibb1 site in 1 country600 target enrollmentJanuary 21, 2018

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: Bristol-Myers Squibb
Enrollment: 600
Locations: 1
Primary Endpoint: Overall Survival (OS)
Status: Active, not recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 21, 2018

End Date

November 30, 2025

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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)

Time Frame: Up to 3 years

By Cohort

Secondary Outcomes

Progression Free Survival (PFS)(Up to 3 years)
Best Overall Response Rate (BORR)(Up to 3 years)
Overall Survival (OS)(Up to 3 years)
Overall Response Rate (ORR)(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(Approximately 3 years)
Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires(Approximately 3 years)