Renal Cell CarcinomaWITNESSNCT03455452
Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer
An observational study of Renal Cell Carcinoma and Renal Cell Cancer, run by Bristol-Myers Squibb at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Renal Cell Cancer, Adenocarcinoma Of Kidney
- How many people
- 623 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2018to 18 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Renal Cell Carcinoma, Renal Cell Cancer, Adenocarcinoma Of Kidney, Adenocarcinoma, Renal Cell, Kidney Cancer, Cancer of the Kidney
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
By Cohort
Measured: Up to 3 years
Secondary outcomes (16)
Overall Survival (OS)
Measured: Up to 3 years
Progression Free Survival (PFS)
Measured: Up to 3 years
Overall Response Rate (ORR)
Measured: Up to 3 years
Best Overall Response Rate (BORR)
Measured: Up to 3 years
Best Overall Response (BOR)
Measured: Up to 3 years
Distribution of socio-demographic characteristics of participants
Measured: Approximately 3 years
Distribution of clinical characteristics of participants
Measured: Approximately 3 years
Distribution of management of participants with treatment-related adverse events (AEs)
Measured: Approximately 3 years
Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score
Measured: At baseline
Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score
Measured: At baseline
Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC)
Measured: Approximately 3 years
Distribution of incidence of AEs
Measured: Approximately 3 years
Distribution of Severity of AEs
Measured: Approximately 3 years
Distribution of management of AEs
Measured: Approximately 3 years
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")
Measured: Approximately 3 years
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)
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start21 Jan 2018
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455452
- Sponsor's protocol ID
- CA209-9GY
- Acronym
- WITNESS
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barthelemy P, Albiges L, Escudier B, Narciso B, Bigot P, Chehimi M, Emambux S, Calcagno F, Mouillet G, Eymard JC, Schlurmann F, Bailly S, Garbay D, Berdah JF, Palmaro MB, Goupil MG, Spaeth D, Nere S, Quentric C, Vano YA, Thiery-Vuillemin A. Nivolumab in patients with advanced renal cell carcinoma in France: interim results of the observational, real-world WITNESS study. ESMO Open. 2024 Jul;9(7):103602. doi: 10.1016/j.esmoop.2024.103602. Epub 2024 Jun 18.
PubMed 38897136
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03455452
- Acronym / sponsor ID
- WITNESS / CA209-9GY
- Conditions
- Renal Cell Carcinoma, Renal Cell Cancer, Adenocarcinoma Of Kidney, Adenocarcinoma, Renal Cell, Kidney Cancer, Cancer of the Kidney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- -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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: Up to 3 years
By Cohort
16 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
Time frame: Approximately 3 years
Distribution of clinical characteristics of participants
Time frame: Approximately 3 years
Distribution of management of participants with treatment-related adverse events (AEs)
Time frame: Approximately 3 years
Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score
Time frame: At baseline
Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score
Time frame: At baseline
Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC)
Time frame: Approximately 3 years
Distribution of incidence of AEs
Time frame: Approximately 3 years
Distribution of Severity of AEs
Time frame: Approximately 3 years
Distribution of management of AEs
Time frame: 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
Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
Time frame: Approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Derived from this study: PubMed 38897136Barthelemy P, Albiges L, Escudier B, Narciso B, Bigot P, Chehimi M, Emambux S, Calcagno F, Mouillet G, Eymard JC, Schlurmann F, Bailly S, Garbay D, Berdah JF, Palmaro MB, Goupil MG, Spaeth D, Nere S, Quentric C, Vano YA, Thiery-Vuillemin A. Nivolumab in patients with advanced renal cell carcinoma in France: interim results of the observational, real-world WITNESS study. ESMO Open. 2024 Jul;9(7):103602. doi: 10.1016/j.esmoop.2024.103602. Epub 2024 Jun 18.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Renal Cell Cancer, run by Bristol-Myers Squibb at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03455452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.