MelanomaNCT03199846
Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2). 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
- Type of treatment
- Injection or infusion
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2016to 31 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: Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.
Who may be able to join
- Adults 18 years or older
- Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
- Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
- Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Who cannot join
- Physicians unwilling or unable to follow study instructions
- Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
Trial locations and contacts
1 site in 1 country.
About this study
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).
- 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 |
|---|---|---|
| advanced melanoma patients | Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma Receives: Other: Non-Interventional | |
| Ipi monotherapy | Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016. Receives: Other: Non-Interventional | |
| Ipi + nivo combination therapy | Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016. Receives: Other: Non-Interventional | |
| Dabrafenib + trametinib combination therapy | Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016. Receives: Other: Non-Interventional | |
| Pembro monotherapy | Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016 Receives: Other: Non-Interventional | |
| Nivo monotherapy | Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016 Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of treatment patterns for advanced melanoma patients
Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy
Measured: Aproximately 6 months
Secondary outcomes (20)
Distribution of prescribing patterns
Distribution of prescribing patterns by type of practice setting and melanoma patient volume
Measured: Approximately 16 months
Distribution of Patient Age at index date
Patient Age at index date will be determined from Medical Records
Measured: at baseline
Distribution of Patient's Sex at Index Date
Patient's sex will be determined from Medical Records
Measured: At Baseline
Distribution of Comorbidities at index date
Comorbidities will be determined using the Charlson Comorbidity Index (CCI)
Measured: At Baseline
Distribution of Healthcare Coverage type
Healthcare Coverage type will be determined using Medical Records
Measured: At Baseline
Distribution of Diagnosis Date
Melanoma Diagnosis Date will be determined using medical records
Measured: At Baseline
Distribution of Advanced Diagnosis Date
Date of advanced/ metastatic melanoma diagnosis will be determined using medical records
Measured: At Baseline
Distribution of Age at Onset
Diagnosis date-Date of Birth
Measured: At Baseline
Distribution of Disease stage at time of diagnosis
Disease stage at time of diagnosis will be determined using medical records
Measured: At Baseline
Distribution of Disease stage at subsequent visits
Disease stage at subsequent visits will be determined using medical records
Measured: Approximately 16 months
Distribution of ECOG status at Baseline
Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records
Measured: At Baseline
Distribution of ECOG status at Last Visit
Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records
Measured: Approximately 16 months
Distribution of Biomarker status at baseline
Biomarker status will be determined using Medical Records
Measured: at baseline
Distribution of treatment-related adverse events
treatment-related adverse events will be determined using medical records
Measured: Approximately 16 months
Distribution of Overall Survival (OS) from Advanced Diagnosis
Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
Measured: Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis
Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
Measured: Approximately 16 months
Distribution of Overall Response Rate (ORR)
Measured: Approximately 16 months
Distribution of Overall Survival (OS) from Index Date
Date of death minus index treatment start date, censoring for LTF or end of observation
Measured: Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Index Date
Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation
Measured: Approximately 16 months
Distribution of melanoma related HCRU
Measured: Approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start25 Oct 2016
- Primary completion30 Oct 2017
- Study completion31 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
- 650 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
- NCT03199846
- Sponsor's protocol ID
- CA209-983
- Status last verified
- Feb 2018
- First submitted
- 23 Jun 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
- ClinicalTrials.gov ID
- NCT03199846
- Acronym / sponsor ID
- CA209-983
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Jun 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 will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| advanced melanoma patients | – | Other: Non-InterventionalPart 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma |
| Ipi monotherapy | – | Other: Non-InterventionalPart 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016. |
| Ipi + nivo combination therapy | – | Other: Non-InterventionalPart 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016. |
| Dabrafenib + trametinib combination therapy | – | Other: Non-InterventionalPart 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016. |
| Pembro monotherapy | – | Other: Non-InterventionalPart 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016 |
| Nivo monotherapy | – | Other: Non-InterventionalPart 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.
Key inclusion criteria (4 listed)
- Adults 18 years or older
- Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
- Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
- Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Key exclusion criteria (2 listed)
- Physicians unwilling or unable to follow study instructions
- Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
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 | Dabrafenib + trametinib combination therapy, Ipi + nivo combination therapy, Ipi monotherapy, Nivo monotherapy, Pembro monotherapy, advanced melanoma patients |
Primary outcome
Distribution of treatment patterns for advanced melanoma patients
Time frame: Aproximately 6 months
Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy
20 secondary outcomes
Distribution of prescribing patterns
Time frame: Approximately 16 months
Distribution of Patient Age at index date
Time frame: at baseline
Distribution of Patient's Sex at Index Date
Time frame: At Baseline
Distribution of Comorbidities at index date
Time frame: At Baseline
Distribution of Healthcare Coverage type
Time frame: At Baseline
Distribution of Diagnosis Date
Time frame: At Baseline
Distribution of Advanced Diagnosis Date
Time frame: At Baseline
Distribution of Age at Onset
Time frame: At Baseline
Distribution of Disease stage at time of diagnosis
Time frame: At Baseline
Distribution of Disease stage at subsequent visits
Time frame: Approximately 16 months
Distribution of ECOG status at Baseline
Time frame: At Baseline
Distribution of ECOG status at Last Visit
Time frame: Approximately 16 months
Distribution of Biomarker status at baseline
Time frame: at baseline
Distribution of treatment-related adverse events
Time frame: Approximately 16 months
Distribution of Overall Survival (OS) from Advanced Diagnosis
Time frame: Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis
Time frame: Approximately 16 months
Distribution of Overall Response Rate (ORR)
Time frame: Approximately 16 months
Distribution of Overall Survival (OS) from Index Date
Time frame: Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Index Date
Time frame: Approximately 16 months
Distribution of melanoma related HCRU
Time frame: Approximately 16 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 6 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 4 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 6 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?
Distribution of treatment patterns for advanced melanoma patients (time frame: Aproximately 6 months). 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 6 Feb 2018.