Advanced MelanomaNCT07079644
Outcomes of Nivolumab in Combination With Relatlimab in Patients With Advanced Melanoma in the Flatiron Database
An observational study of Advanced Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to investigate the real-world clinical outcomes of individuals that have been diagnosed with advanced melanoma who were treated with Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Nivolumab + Relatlimab, Nivolumab + Ipilimumab and Immunotherapy monotherapy
- How many people
- 678 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2024to 31 Mar 2025
- 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 will include adults identified from the Flatiron database that have been diagnosed with advanced melanoma and who have initiated treatment with either Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy in the real-world clinical settings
Who may be able to join
- Participants in the advanced melanoma cohort
- Participants included in the cohort by Flatiron criteria of: cutaneous melanoma with pathologic stages III or IV, either at initial diagnosis or via local or distant recurrence, and at least two clinic encounters evident in the database
- Participants receiving Nivolumab + Relatlimab between March 18, 2022 and September 30, 2024 or other therapies (Nivolumab + Ipilimumab, immunotherapy monotherapy, BRAF/MEK inhibitors) between March 18, 2022 and November 30, 2024 (or date of the most recent data cut off)
- Participants ≥18 years old on index date
- Participants with ≥1 month of medical data after the index date (inclusive), unless patient died within this period
Who cannot join
- Participants with diagnosis of other primary cancers prior to the index date
- Participants receiving medication in a clinical trial at any time prior to, on or after index date
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol Myers Squibb
Princeton, New Jersey, 08540-4715
About this study
Official title: Real World Outcomes of Nivolumab + Relatlimab in Patients With Advanced Melanoma in the Flatiron Database
The purpose of this study is to investigate the real-world clinical outcomes of individuals that have been diagnosed with advanced melanoma who were treated with Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy
- Conditions
- Advanced Melanoma
- Being tested
- Nivolumab + Relatlimab, Nivolumab + Ipilimumab, Immunotherapy monotherapy, BRAF/MEK inhibitors
- Keywords
- Advanced melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab + RelatlimabBiological
As per product label
Nivolumab + IpilimumabBiological
As per product label
Immunotherapy monotherapyBiological
As per product label
BRAF/MEK inhibitorsDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| 1L Nivolumab + Relatlimab cohort | Not described Receives: Biological: Nivolumab + Relatlimab | |
| 1L Nivolumab + Ipilimumab cohort | Not described Receives: Biological: Nivolumab + Ipilimumab | |
| 1L Immunotherapy monotherapy cohort | Not described Receives: Biological: Immunotherapy monotherapy | |
| 1L BRAF/MEKs inhibitors cohort | Not described Receives: Drug: BRAF/MEK inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Measured: Baseline
Clinical characteristics: Location of metastatic sites
Measured: Baseline
Clinical characteristics: Lactate dehydrogenate (LDH) test results
Measured: Baseline
Clinical characteristics: BRAF status
Measured: Baseline
Clinical characteristics: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Measured: Baseline
Overall survival (OS)
Measured: Up to 3-years
Real-world progression-free survival (rwPFS)
Measured: Up to 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start29 Nov 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 678 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
- NCT07079644
- Sponsor's protocol ID
- CA224-1098
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Outcomes of Nivolumab + Relatlimab in Patients With Advanced Melanoma in the Flatiron Database
- ClinicalTrials.gov ID
- NCT07079644
- Acronym / sponsor ID
- CA224-1098
- Conditions
- Advanced Melanoma
- Keywords
- Advanced melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 23 Jul 2025 (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 investigate the real-world clinical outcomes of individuals that have been diagnosed with advanced melanoma who were treated with Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1L Nivolumab + Relatlimab cohort | – | Biological: Nivolumab + Relatlimab |
| 1L Nivolumab + Ipilimumab cohort | – | Biological: Nivolumab + Ipilimumab |
| 1L Immunotherapy monotherapy cohort | – | Biological: Immunotherapy monotherapy |
| 1L BRAF/MEKs inhibitors cohort | – | Drug: BRAF/MEK inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults identified from the Flatiron database that have been diagnosed with advanced melanoma and who have initiated treatment with either Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy in the real-world clinical settings
Key inclusion criteria (5 listed)
- Participants in the advanced melanoma cohort
- Participants receiving Nivolumab + Relatlimab between March 18, 2022 and September 30, 2024 or other therapies (Nivolumab + Ipilimumab, immunotherapy monotherapy, BRAF/MEK inhibitors) between March 18, 2022 and November 30, 2024 (or date of the most recent data cut off)
- Participants ≥18 years old on index date
- Participants with ≥1 month of medical data after the index date (inclusive), unless patient died within this period
Key exclusion criteria (2 listed)
- Participants with diagnosis of other primary cancers prior to the index date
- Participants receiving medication in a clinical trial at any time prior to, on or after index date
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 |
|---|---|---|
| Nivolumab + RelatlimabAs per product label | Biological | 1L Nivolumab + Relatlimab cohort |
| Nivolumab + IpilimumabAs per product label | Biological | 1L Nivolumab + Ipilimumab cohort |
| Immunotherapy monotherapyAs per product label | Biological | 1L Immunotherapy monotherapy cohort |
| BRAF/MEK inhibitorsAs per product label | Drug | 1L BRAF/MEKs inhibitors cohort |
Primary outcome
Demographics
Time frame: Baseline
Clinical characteristics: Location of metastatic sites
Time frame: Baseline
Clinical characteristics: Lactate dehydrogenate (LDH) test results
Time frame: Baseline
Clinical characteristics: BRAF status
Time frame: Baseline
Clinical characteristics: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time frame: Baseline
Overall survival (OS)
Time frame: Up to 3-years
Real-world progression-free survival (rwPFS)
Time frame: Up to 3-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 23 Jul 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Advanced 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 5 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 Jul 2025. 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?
Demographics (time frame: Baseline). The study lists 7 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 Jul 2025.