MelanomaNCT03448497
Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced Melanoma in the United Kingdom
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination 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?
- Non-interventional
- How many people
- 333 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2017to 27 Apr 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: The study population includes treatment-naïve patients with advanced (unresectable or metastatic) melanoma who initiated first-line therapy.
Who may be able to join
- Patient has medical chart documentation of advanced (unresectable or metastatic) melanoma.
- Patient initiated a first-line therapy for the treatment of advanced melanoma during the eligibility period (01 July 2016 to 01 July 2017; index event).
- Patient did not receive systemic treatment for their advanced (unresectable or metastatic) melanoma prior to index event
- Patient initiated first-line therapy at least six months before the date their chart abstraction initiated
Who cannot join
- Patient was enrolled in an investigational drug clinical trial or participating in medical research judged to directly affect how the patient was being monitored/treated while receiving first-line therapy
- Patient had another active concurrent malignancy other than advanced melanoma, which required systemic treatment at the time of index event
- Part or all of the patient's first-line treatment was received at a different site and the patient's medical chart pertaining to this care is not accessible
- Patient medical chart is missing, empty, or not retrievable
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Local Institution
Cambridge, Cambridgeshire, CB16GQ
About this study
Official title: Retrospective Chart Review Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom
The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination therapy.
- 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 who intiated first-line therapy | patients who initiated any first-line therapy for advanced melanoma and had not previously received treatment for their advanced disease Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response (BOR) rate
In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Measured: Up to 18 months
Secondary outcomes (14)
Distribution of patient demographic characteristics
Including age, sex, ethnic group, height, weight, and BMI
Measured: At baseline
Prior melanoma treatment history
Type of intervention used to treat melanoma
Measured: At baseline
Serum concentration of lactate dehydrogenase (LDH)
Measured: At baseline
Eastern Cooperative Oncology Group (ECOG) score
Measured: Up to 18 months
Distribution of first-line treatment patterns
Details on Treatment Patterns will be summarized using descriptive statistics
Measured: Up to 18 months
Distribution of subsequent therapy line treatment patterns
Details on Treatment Patterns will be summarized using descriptive statistics
Measured: Up to 18 months
Progression Free Survival (PFS)
Time from first-line initiation until disease progression or death in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Measured: Up to 18 months
Treatment-Free Interval (TFI)
Time from nivolumab + ipilimumab combination therapy discontinuation to date of progressive disease in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Measured: Up to 18 months
Overall Survival (OS)
Time from treatment initiation until death in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Measured: Up to 18 months
Distribution of PD-L1 threshold
PD-L1 threshold used for first-line treatment selection in patients where PD-L1 was tested
Measured: At baseline
Incidence of adverse events of Special interest(AESI)
in a subset of patients receiving nivolumab + ipilimumab combo therapy. AESIs include select gastrointestinal, renal, pulmonary, hepatic, endocrine, skin, neurological, and infusion reaction.
Measured: Up to 18 months
Incidence of serious adverse events (SAE)
in a subset of patients receiving nivolumab + ipilimumab combo therapy. SAE defined as Common Terminology Criteria for Adverse Events (CTCAE) grades 3+ adverse events
Measured: Up to 18 months
Distribution of AESI management
In a subset of patients receiving Nivo + Ipi combo therapy
Measured: up to 18 months
melanoma related healthcare resource utilization (HCRU)
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start14 Dec 2017
- Primary completion27 Apr 2018
- Study completion27 Apr 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
- 333 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
- NCT03448497
- Sponsor's protocol ID
- CA209-9TW
- Status last verified
- Aug 2019
- First submitted
- 12 Feb 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom
- ClinicalTrials.gov ID
- NCT03448497
- Acronym / sponsor ID
- CA209-9TW
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 28 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.
The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Melanoma patients who intiated first-line therapy | – | Other: Non-interventionalpatients who initiated any first-line therapy for advanced melanoma and had not previously received treatment for their advanced disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes treatment-naïve patients with advanced (unresectable or metastatic) melanoma who initiated first-line therapy.
Key inclusion criteria (4 listed)
- Patient has medical chart documentation of advanced (unresectable or metastatic) melanoma.
- Patient initiated a first-line therapy for the treatment of advanced melanoma during the eligibility period (01 July 2016 to 01 July 2017; index event).
- Patient did not receive systemic treatment for their advanced (unresectable or metastatic) melanoma prior to index event
- Patient initiated first-line therapy at least six months before the date their chart abstraction initiated
Key exclusion criteria (5 listed)
- Patient was enrolled in an investigational drug clinical trial or participating in medical research judged to directly affect how the patient was being monitored/treated while receiving first-line therapy
- Patient had another active concurrent malignancy other than advanced melanoma, which required systemic treatment at the time of index event
- Part or all of the patient's first-line treatment was received at a different site and the patient's medical chart pertaining to this care is not accessible
- Patient medical chart is missing, empty, or not retrievable
- 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 | Advanced Melanoma patients who intiated first-line therapy |
Primary outcome
Best Overall Response (BOR) rate
Time frame: Up to 18 months
In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
14 secondary outcomes
Distribution of patient demographic characteristics
Time frame: At baseline
Prior melanoma treatment history
Time frame: At baseline
Serum concentration of lactate dehydrogenase (LDH)
Time frame: At baseline
Eastern Cooperative Oncology Group (ECOG) score
Time frame: Up to 18 months
Distribution of first-line treatment patterns
Time frame: Up to 18 months
Distribution of subsequent therapy line treatment patterns
Time frame: Up to 18 months
Progression Free Survival (PFS)
Time frame: Up to 18 months
Treatment-Free Interval (TFI)
Time frame: Up to 18 months
Overall Survival (OS)
Time frame: Up to 18 months
Distribution of PD-L1 threshold
Time frame: At baseline
Incidence of adverse events of Special interest(AESI)
Time frame: Up to 18 months
Incidence of serious adverse events (SAE)
Time frame: Up to 18 months
Distribution of AESI management
Time frame: up to 18 months
melanoma related healthcare resource utilization (HCRU)
Time frame: Up to 18 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 Aug 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 United Kingdom.
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 5 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 Aug 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 United Kingdom. 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?
Best Overall Response (BOR) rate (time frame: Up to 18 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 Aug 2019.