MelanomaNCT03438279
Survival Study for Participants Treated With Ipilimumab-Nivolumab Combination Therapy
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable. 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
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2015to 28 Dec 2017
- 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: Individual patient data (IPD) from the ipilimumab pooled analysis of clinical trials and observational studies will be used to construct the prognostic model for OS in advanced melanoma patients.
Who may be able to join
- Diagnosis of melanoma
Who cannot join
- Age less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Projecting Survival for Patients Treated With First-Line Ipilimumab-Nivolumab Combination Therapy Using a Prognostic Model and Cost Per Responder Model of Ipilimumab-Nivolumab Combination Therapy
This study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable.
- 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 |
|---|---|---|
| First-Line Ipilimumab | patients who received ipilimumab as their first-line treatment Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic Model of Overall Survival (OS)
The OS prognostic model uses Individual patient data from a pooled analysis of 12 ipilimumab studies.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start23 Jun 2015
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
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
- 600 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
- NCT03438279
- Sponsor's protocol ID
- CA209-437
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 19 Feb 2018
- 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Projecting Survival for Patients Treated With First-Line Ipilimumab-Nivolumab Combination Therapy Using a Prognostic Model and Cost Per Responder Model of Ipilimumab-Nivolumab Combination Therapy
- ClinicalTrials.gov ID
- NCT03438279
- Acronym / sponsor ID
- CA209-437
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 19 Feb 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 study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-Line Ipilimumab | – | Other: Non-Interventionalpatients who received ipilimumab as their first-line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individual patient data (IPD) from the ipilimumab pooled analysis of clinical trials and observational studies will be used to construct the prognostic model for OS in advanced melanoma patients.
Key inclusion criteria (1 listed)
- Diagnosis of melanoma
Key exclusion criteria (1 listed)
- Age less than 18 years old
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 | First-Line Ipilimumab |
Primary outcome
Prognostic Model of Overall Survival (OS)
Time frame: 10 years
The OS prognostic model uses Individual patient data from a pooled analysis of 12 ipilimumab studies.
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 19 Feb 2018.
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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 United States.
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 1 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 19 Feb 2018. 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 United States. 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?
Prognostic Model of Overall Survival (OS) (time frame: 10 years). 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 19 Feb 2018.