Renal Cell CarcinomaNCT03663946
A Study to Observe the Onset of Immune-related Adverse Reactions in Patients With Non-surgical or Renal Cell Carcinoma (RCC) That Has Spread
An observational study of Renal Cell Carcinoma and Kidney Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cell Carcinoma, Kidney Cancer
- What is being tested?
- Non-Interventional
- How many people
- 81 participants
- Where
- 1 siteJapan
- Study dates
- 18 Sep 2018to 30 May 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: Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo
Who may be able to join
- Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo in accordance with the Japanese package insert will be included in this PMS
Who cannot join
- Patients receiving combination therapy with Yervoy and Opdivo for non RCC indication will be excluded from this PMS
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Being tested
- Non-Interventional
- 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.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Patients taking combination therapy with Yervoy and Opdivo | Medical records will be reviewed for safety and treatments for specific ADR Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immune-related AE's
Measured: Approximately 13 weeks
Incidence of immune related SAE's
Measured: Approximately 13 weeks
Secondary outcomes (3)
Incidence of treatment for immune-related adverse reactions
Measured: Approximately 13 weeks
Incidence of unknown AE's
Measured: Approximately 13 weeks
Incidence of unknown SAE's
Measured: Approximately 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start18 Sep 2018
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 81 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
- NCT03663946
- Sponsor's protocol ID
- CA209-8MK
- Status last verified
- Feb 2022
- First submitted
- 7 Sep 2018
- Last updated
- 25 Feb 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 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)
- ClinicalTrials.gov ID
- NCT03663946
- Acronym / sponsor ID
- CA209-8MK
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 10 Sep 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.
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients taking combination therapy with Yervoy and Opdivo | – | Other: Non-InterventionalMedical records will be reviewed for safety and treatments for specific ADR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo
Key inclusion criteria (1 listed)
- Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo in accordance with the Japanese package insert will be included in this PMS
Key exclusion criteria (2 listed)
- Patients receiving combination therapy with Yervoy and Opdivo for non RCC indication will be excluded from this PMS
- 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 | Patients taking combination therapy with Yervoy and Opdivo |
Primary outcome
Incidence of immune-related AE's
Time frame: Approximately 13 weeks
Incidence of immune related SAE's
Time frame: Approximately 13 weeks
3 secondary outcomes
Incidence of treatment for immune-related adverse reactions
Time frame: Approximately 13 weeks
Incidence of unknown AE's
Time frame: Approximately 13 weeks
Incidence of unknown SAE's
Time frame: Approximately 13 weeks
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 25 Feb 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink 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 Renal Cell Carcinoma and Kidney 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 25 Feb 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?
Incidence of immune-related AE's (time frame: Approximately 13 weeks). The study lists 2 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 25 Feb 2022.