MelanomaNCT03165422
A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Non-Interventional
- How many people
- 68 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2017to 29 Dec 2018
- 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 patients with melanoma who are patients at the participating centers in Japan will be enrolled.
Who may be able to join
- Adult patients > 18 years of age or older
- Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
- Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment
Who cannot join
- Patients enrolled in any clinical trials at any time
- Overlapping use of nivolumab and ipilimumab
Trial locations and contacts
1 site in 1 country.
About this study
This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan
- Conditions
- Melanoma
- Being tested
- Non-Interventional
- Medical subject headings
- Melanoma
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 |
|---|---|---|
| Adult patients with melanoma | Adult patients with melanoma at participating centers in Japan Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ipilimumab treatment after nivolumab treatment
Measured: Approximately 19 months
Incidence of nivolumab treatment after ipilimumab treatment
Measured: Approximately 19 months
Duration of nivolumab treatment
Measured: Approximately 19 months
Duration of ipilimumab treatment
Measured: Approximately 19 months
Duration of interval between nivolumab treatment and ipilimumab treatment
Measured: Approximately 19 months
Secondary outcomes (6)
overall response rate (ORR)
Measured: Approximately 19 months
best overall response rate (BORR)
Measured: Approximately 19 months
overall survival (OS)
Measured: Approximately 19 months
progression-free survival (PFS)
Measured: Approximately 19 months
incidence of treatment-related adverse events (AEs)
incidence of treatment-related adverse events (AEs)/adverse reactions (ARs)
Measured: Approximately 19 months
severity of treatment-related adverse events (AEs)
severity of treatment-related adverse events (AEs)/adverse reactions (ARs)
Measured: Approximately 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Mar 2017
- Primary completion29 Dec 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165422
- Sponsor's protocol ID
- CA209-9DA
- Status last verified
- Oct 2019
- First submitted
- 16 May 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan
- ClinicalTrials.gov ID
- NCT03165422
- Acronym / sponsor ID
- CA209-9DA
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 29 Dec 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 24 May 2017 (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 medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with melanoma | – | Other: Non-InterventionalAdult patients with melanoma at participating centers in Japan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with melanoma who are patients at the participating centers in Japan will be enrolled.
Key inclusion criteria (3 listed)
- Adult patients > 18 years of age or older
- Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
- Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment
Key exclusion criteria (2 listed)
- Patients enrolled in any clinical trials at any time
- Overlapping use of nivolumab and ipilimumab
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 | Adult patients with melanoma |
Primary outcome
Incidence of ipilimumab treatment after nivolumab treatment
Time frame: Approximately 19 months
Incidence of nivolumab treatment after ipilimumab treatment
Time frame: Approximately 19 months
Duration of nivolumab treatment
Time frame: Approximately 19 months
Duration of ipilimumab treatment
Time frame: Approximately 19 months
Duration of interval between nivolumab treatment and ipilimumab treatment
Time frame: Approximately 19 months
6 secondary outcomes
overall response rate (ORR)
Time frame: Approximately 19 months
best overall response rate (BORR)
Time frame: Approximately 19 months
overall survival (OS)
Time frame: Approximately 19 months
progression-free survival (PFS)
Time frame: Approximately 19 months
incidence of treatment-related adverse events (AEs)
Time frame: Approximately 19 months
severity of treatment-related adverse events (AEs)
Time frame: Approximately 19 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 23 Oct 2019.
- 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 Melanoma, 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 3 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 23 Oct 2019. 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 ipilimumab treatment after nivolumab treatment (time frame: Approximately 19 months). The study lists 5 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 23 Oct 2019.