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

Active, not recruiting

• Conditions: Renal Cell Cancer; Kidney Cancer; Adenocarcinoma, Renal Cell; Renal Cell Carcinoma; Cancer of the Kidney; Adenocarcinoma Of Kidney

• Registration Number: NCT03455452
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-01-21
• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 3 years	By Cohort

Secondary Outcome Measures

Name	Time	Method
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
Overall Survival (OS)	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	The FKSI-19 will be graded by the patient on a scale from 0 to 4 (range "not at all to very much")
Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires	Approximately 3 years	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)

Trial Locations

Locations (1)

Local Institution - 0001; 🇫🇷 Paris, France