Renal Cell CarcinomaNCT02940639
Real-Life Effectiveness and Safety in Participants With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy
An observational study of Renal Cell Carcinoma, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 499 participants
- Where
- 1 siteGermany
- Study dates
- 27 Oct 2016to 3 Jun 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 years of age at the time of the treatment decision with the diagnosis of advanced/metastatic RCC (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with 1st line nivolumab and ipilimumab nivolumab combination therapy in intermediate/poor risk participants according to International Metastatic RCC Database Consortium (IMDC) score or with nivolumab monotherapy after prior therapy for the first time for the treatment of advanced/metastatic RCC, according to the label approved in Germany.
Who may be able to join
- Adult participants, at least 18 years of age at time of treatment decision
- Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
- Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
- Signed informed consent
Who cannot join
- Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
- Participants previously treated with nivolumab and/or ipilimumab
- Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National, Prospective, Non-Interventional Study (NIS) in Patients With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy
The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany
- Conditions
- Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
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 | Participants with advanced/metastatic renal cell cancer (RCC) starting nivolumab monotherapy after prior therapy | |
| Cohort 2 | Participants with advanced/metastatic RCC starting 1st line therapy with nivolumab and ipilimumab combination therapy, in intermediate/poor risk participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
In participants with nivolumab and ipilimumab or nivolumab therapy
Measured: Approximately 5 years
Secondary outcomes (17)
Overall Survival (OS)
Separate by nivolumab and ipilimumab or nivolumab therapy, estimated overall lines of therapy, per line of therapy, per cohort, per index date (initial diagnosis vs start of therapy in the trial) and per subgroups of interest.
Measured: Approximately 5 years
Progression-Free Survival (PFS)
Measured: Approximately 5 years
Overall response rate (ORR)
Measured: Approximately 5 years
Best Overall Response (BOR)
Measured: Approximately 5 years
Best Overall Response Rate (BORR)
Measured: Approximately 5 years
Duration of Response
Measured: Approximately 5 years
Distribution of socio-demographic characteristics
Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.
Measured: Approximately 5 years
Distribution of clinical characteristics
Clinical characteristics (Initial Diagnosis of RCC, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics
Measured: Approximately 5 years
Distribution of Renal Cell Carcinoma (RCC) Treatment History
Measured: At Baseline
Distribution of Nivolumab Treatment Characteristics
Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)
Measured: At initiation - index date, baseline
Distribution of Treatment Patterns
Details on prior and evolution of current treatment patterns
Measured: Approximately 5 years
Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs
Measured: Approximately 5 years
Distribution of Adverse Events (AE) characteristics
Measured: Approximately 5 years
Distribution of severity of Adverse Events (AEs)
Measured: Approximately 5 years
Distribution of management of Adverse Events (AEs)
Measured: Approximately 5 years
Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire
Measured: Approximately 5 years
Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start27 Oct 2016
- Primary completion3 Jun 2025
- Study completion3 Jun 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
- 499 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
- NCT02940639
- Sponsor's protocol ID
- CA209-653
- Status last verified
- Jul 2025
- First submitted
- 12 Oct 2016
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bedke J, Grimm MO, Grunwald V. Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study. Future Oncol. 2018 May;14(11):1023-1034. doi: 10.2217/fon-2017-0637. Epub 2018 Jan 12.
PubMed 29325434
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective, Non-Interventional Study (NIS) in Patients With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy
- ClinicalTrials.gov ID
- NCT02940639
- Acronym / sponsor ID
- CA209-653
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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.
The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with advanced/metastatic renal cell cancer (RCC) starting nivolumab monotherapy after prior therapy |
| Cohort 2 | – | –Participants with advanced/metastatic RCC starting 1st line therapy with nivolumab and ipilimumab combination therapy, in intermediate/poor risk participants |
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 years of age at the time of the treatment decision with the diagnosis of advanced/metastatic RCC (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with 1st line nivolumab and ipilimumab nivolumab combination therapy in intermediate/poor risk participants according to International Metastatic RCC Database Consortium (IMDC) score or with nivolumab monotherapy after prior therapy for the first time for the treatment of advanced/metastatic RCC, according to the label approved in Germany.
Key inclusion criteria (4 listed)
- Adult participants, at least 18 years of age at time of treatment decision
- Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
- Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
- Signed informed consent
Key exclusion criteria (3 listed)
- Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
- Participants previously treated with nivolumab and/or ipilimumab
- Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled.
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: Approximately 5 years
In participants with nivolumab and ipilimumab or nivolumab therapy
17 secondary outcomes
Overall Survival (OS)
Time frame: Approximately 5 years
Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Overall response rate (ORR)
Time frame: Approximately 5 years
Best Overall Response (BOR)
Time frame: Approximately 5 years
Best Overall Response Rate (BORR)
Time frame: Approximately 5 years
Duration of Response
Time frame: Approximately 5 years
Distribution of socio-demographic characteristics
Time frame: Approximately 5 years
Distribution of clinical characteristics
Time frame: Approximately 5 years
Distribution of Renal Cell Carcinoma (RCC) Treatment History
Time frame: At Baseline
Distribution of Nivolumab Treatment Characteristics
Time frame: At initiation - index date, baseline
Distribution of Treatment Patterns
Time frame: Approximately 5 years
Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs
Time frame: Approximately 5 years
Distribution of Adverse Events (AE) characteristics
Time frame: Approximately 5 years
Distribution of severity of Adverse Events (AEs)
Time frame: Approximately 5 years
Distribution of management of Adverse Events (AEs)
Time frame: Approximately 5 years
Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire
Time frame: Approximately 5 years
Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
Time frame: Approximately 5 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 11 Jul 2025.
- Derived from this study: PubMed 29325434Bedke J, Grimm MO, Grunwald V. Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study. Future Oncol. 2018 May;14(11):1023-1034. doi: 10.2217/fon-2017-0637. Epub 2018 Jan 12.
- BMS Clinical Trial InformationLink provided by the sponsor.
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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, run by Bristol-Myers Squibb at 1 site in Germany.
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 4 inclusion and 3 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 11 Jul 2025. 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 Germany. 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: Approximately 5 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 NCT02940639, 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 11 Jul 2025.