Kidney CancerNCT03568435
Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants
An observational study of Kidney Cancer and Renal Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Cancer, Renal Cancer
- What is being tested?
- Non-Interventional
- How many people
- 212 participants
- Where
- 1 siteJapan
- Study dates
- 14 Feb 2018to 21 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with RCC with distant metastasis treated with nivolumab under real clinical practice
Who may be able to join
- A patient with RCC with distant metastasis treated for the first time with nivolumab
Who cannot join
- Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review
A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer
- Conditions
- Kidney Cancer, Renal Cancer
- Being tested
- Non-Interventional
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Participants with metastatic RCC taking nivolumab | Specified dose on specified day Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival status
Measured: 6 months
Overall survival status
Measured: 36 months
Best overall response
Measured: 6 months
Best overall response
Measured: 36 months
Progression free survival rate
Measured: 6 months
Progression free survival rate
Measured: 36 months
Disease free survival
Measured: 6 months
Disease free survival
Measured: 36 months
Objective response rate
Measured: 6 months
Objective response rate
Measured: 36 months
Duration of response
Measured: 6 months
Duration of response
Measured: 36 months
Incidence of adverse events
Measured: 36 months
Incidence of serious adverse events
Measured: 36 months
Secondary outcomes (2)
Distribution of clinical characteristics
Measured: 36 months
Distribution of socio-demographic characteristics
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start14 Feb 2018
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies 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
- Retrospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568435
- Sponsor's protocol ID
- CA209-8D3
- Status last verified
- Oct 2022
- First submitted
- 14 Jun 2018
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review
- ClinicalTrials.gov ID
- NCT03568435
- Acronym / sponsor ID
- CA209-8D3
- Conditions
- Kidney Cancer, Renal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 26 Jun 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.
A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with metastatic RCC taking nivolumab | – | Other: Non-InterventionalSpecified dose on specified day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with RCC with distant metastasis treated with nivolumab under real clinical practice
Key inclusion criteria (1 listed)
- A patient with RCC with distant metastasis treated for the first time with nivolumab
Key exclusion criteria (2 listed)
- Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Participants with metastatic RCC taking nivolumab |
Primary outcome
Overall survival status
Time frame: 6 months
Overall survival status
Time frame: 36 months
Best overall response
Time frame: 6 months
Best overall response
Time frame: 36 months
Progression free survival rate
Time frame: 6 months
Progression free survival rate
Time frame: 36 months
Disease free survival
Time frame: 6 months
Disease free survival
Time frame: 36 months
Objective response rate
Time frame: 6 months
Objective response rate
Time frame: 36 months
Duration of response
Time frame: 6 months
Duration of response
Time frame: 36 months
Incidence of adverse events
Time frame: 36 months
Incidence of serious adverse events
Time frame: 36 months
2 secondary outcomes
Distribution of clinical characteristics
Time frame: 36 months
Distribution of socio-demographic characteristics
Time frame: 36 months
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 20 Oct 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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 Kidney Cancer and Renal Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
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 1 inclusion and 2 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 20 Oct 2022. 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 Japan. 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 status (time frame: 6 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.