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

June 19, 2025 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75002
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants who are at least 18 of age at the time of the treatment decision with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with nivolumab or with nivolumab plus ipilimumab for the first time for the treatment of RCC, according to the label approved in France.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort 1: Nivolumab
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
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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 3 years
Up to 3 years
Progression Free Survival (PFS)
Time Frame: Up to 3 years
Up to 3 years
Overall Response Rate (ORR)
Time Frame: Up to 3 years
Up to 3 years
Best Overall Response Rate (BORR)
Time Frame: Up to 3 years
Up to 3 years
Best Overall Response (BOR)
Time Frame: Up to 3 years
Up to 3 years
Distribution of socio-demographic characteristics of participants
Time Frame: Approximately 3 years
Approximately 3 years
Distribution of clinical characteristics of participants
Time Frame: Approximately 3 years
Approximately 3 years
Distribution of management of participants with treatment-related adverse events (AEs)
Time Frame: Approximately 3 years
Approximately 3 years
Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score
Time Frame: At baseline
At baseline
Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score
Time Frame: At baseline
At baseline
Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC)
Time Frame: Approximately 3 years
Approximately 3 years
Distribution of incidence of AEs
Time Frame: Approximately 3 years
Approximately 3 years
Distribution of Severity of AEs
Time Frame: Approximately 3 years
Approximately 3 years
Distribution of management of AEs
Time Frame: Approximately 3 years
Approximately 3 years
Health-related quality of life of participants using Functional Assessment of Cancer Therapy -Kidney Symptom Index (FKSI-19) questionnaires
Time Frame: 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")
Approximately 3 years
Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
Time Frame: 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)
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2018

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9GY

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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