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

Renal Cell Carcinoma Clinical Trial

— WITNESS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03455452
• Other study ID #: CA209-9GY
• Status: Active, not recruiting
• Start date: January 21, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Local Institution - 0001	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	By Cohort	Up to 3 years
Secondary	Overall Survival (OS)		Up to 3 years
Secondary	Progression Free Survival (PFS)		Up to 3 years
Secondary	Overall Response Rate (ORR)		Up to 3 years
Secondary	Best Overall Response Rate (BORR)		Up to 3 years
Secondary	Best Overall Response (BOR)		Up to 3 years
Secondary	Distribution of socio-demographic characteristics of participants		Approximately 3 years
Secondary	Distribution of clinical characteristics of participants		Approximately 3 years
Secondary	Distribution of management of participants with treatment-related adverse events (AEs)		Approximately 3 years
Secondary	Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score		At baseline
Secondary	Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score		At baseline
Secondary	Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC)		Approximately 3 years
Secondary	Distribution of incidence of AEs		Approximately 3 years
Secondary	Distribution of Severity of AEs		Approximately 3 years
Secondary	Distribution of management of AEs		Approximately 3 years
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form