MelanomaNCT03165409
Cost of Adverse Events Related to How Often Follow-Up Occurs Among Patients With Cancer That Has Spread
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study is a real-world retrospective claims analysis to assess and compare AE-related HCRU and medical costs among patients with different follow-up frequency after initiating a melanoma therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Nivolumab and Ipilimumab
- How many people
- 1,828 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 30 Sep 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: Adult patients who were diagnosed with metastatic melanoma and initiated at least 1 treatment for metastatic melanoma after 2011 will be identified from the IMS PharMetrics Plus US Claims Database and included in the study sample. Patients must have had continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date. The population from the CheckMate-067 (CA209-067) clinical trial will also be included. The population consists of all patients who received at least 1 dose of study drug.
Who may be able to join
- Diagnosed with metastatic melanoma
- Initiated at least 1 treatment for metastatic melanoma after 2011
- Continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date
- Patients who received at least 1 dose of study drug in CA209-067
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Economic Burden of Adverse Events Associated With Follow-Up Frequency Among Patients With Metastatic Melanoma
This study is a real-world retrospective claims analysis to assess and compare AE-related HCRU and medical costs among patients with different follow-up frequency after initiating a melanoma therapy.
- Conditions
- Melanoma
- Being tested
- Nivolumab, Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558, Opdivo
Melanoma intervention
IpilimumabBiological
Also called BMS-734016, Yervoy
Melanoma intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with less frequent general outpatient visits
Measured: Approximately 5 years
Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with more frequent general outpatient visits
Measured: Approximately 5 years
Treatment-related and all-cause AE costs for nivolumab/ipilimumab combination therapy for metastatic melanoma
Measured: Approximately 5 years
Treatment-related and all-cause AE costs for nivolumab monotherapy for metastatic melanoma
Measured: Approximately 5 years
Treatment-related and all-cause AE costs for ipilimumab monotherapy for metastatic melanoma
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 posted24 May 2017
- Study start27 Feb 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,828 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
- NCT03165409
- Sponsor's protocol ID
- CA209-789
- Status last verified
- Oct 2017
- First submitted
- 23 May 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Burden of Adverse Events Associated With Follow-Up Frequency Among Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT03165409
- Acronym / sponsor ID
- CA209-789
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,828 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (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 study is a real-world retrospective claims analysis to assess and compare AE-related HCRU and medical costs among patients with different follow-up frequency after initiating a melanoma therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who were diagnosed with metastatic melanoma and initiated at least 1 treatment for metastatic melanoma after 2011 will be identified from the IMS PharMetrics Plus US Claims Database and included in the study sample. Patients must have had continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date. The population from the CheckMate-067 (CA209-067) clinical trial will also be included. The population consists of all patients who received at least 1 dose of study drug.
Key inclusion criteria (4 listed)
- Diagnosed with metastatic melanoma
- Initiated at least 1 treatment for metastatic melanoma after 2011
- Continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date
- Patients who received at least 1 dose of study drug in CA209-067
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NivolumabAlso: BMS-936558, OpdivoMelanoma intervention | Biological | – |
| IpilimumabAlso: BMS-734016, YervoyMelanoma intervention | Biological | – |
Primary outcome
Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with less frequent general outpatient visits
Time frame: Approximately 5 years
Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with more frequent general outpatient visits
Time frame: Approximately 5 years
Treatment-related and all-cause AE costs for nivolumab/ipilimumab combination therapy for metastatic melanoma
Time frame: Approximately 5 years
Treatment-related and all-cause AE costs for nivolumab monotherapy for metastatic melanoma
Time frame: Approximately 5 years
Treatment-related and all-cause AE costs for ipilimumab monotherapy for metastatic melanoma
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 5 Oct 2017.
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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 4 inclusion and 0 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 5 Oct 2017. 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?
Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with less frequent general outpatient visits (time frame: Approximately 5 years). 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 5 Oct 2017.