MelanomaNCT07091695
Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to understand the characteristics of adults diagnosed with with clinically palpable stage III resectable melanoma, the associated treatment patterns for their disease, and outcomes associated with the real-world use of neoadjuvant nivolumab+relatlimab or nivolumab+ipilimumab 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 + relatlimab and Nivolumab + ipilimumab
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2025to 6 Nov 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 comprise of adult diagnosed with clinically palpable stage III resectable melanoma in the U.S. managed by physicians in Cardinal Health's OPEN treated with neoadjuvant nivolumab+relatimab or nivolumab+ipilimumab from 18 March 2022.
Who may be able to join
- Participants at least 18 years old at diagnosis of clinically palpable stage III resectable melanoma
- Participants treated with nivolumab+relatimab (nivo+rela) or nivolumab+ipilimumab (nivo+ipi) in the neoadjuvant setting
- Participants with at least 6 months of follow-up from initiation of neoadjuvant therapy, unless deceased prior to 6 months of follow-up
Who cannot join
- Participants received nivo+rela or nivo+ipi for clinically palpable stage III resectable melanoma as part of a therapeutic clinical trial
- Participants had history of diagnosis of any malignancy (except for non-melanoma skin cancer) in the last 2 years.
- Participants received adjuvant nivo+rela or adjuvant nivo+ipi after neoadjuvant nivo+ipi
- Participants received adjuvant nivo+ipi after neoadjuvant nivo+rela
- Participants received any systemic therapy prior to the initiation of neoadjuvant nivo+rela or nivo+ipi
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab (Nivo+Rela) or Nivolumab+Ipilimumab (Nivo+Ipi)
The purpose of this study is to understand the characteristics of adults diagnosed with with clinically palpable stage III resectable melanoma, the associated treatment patterns for their disease, and outcomes associated with the real-world use of neoadjuvant nivolumab+relatlimab or nivolumab+ipilimumab
- Conditions
- Melanoma
- Being tested
- Nivolumab + relatlimab, 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.
Nivolumab + relatlimabBiological
As prescribed by the treating clinician
Nivolumab + ipilimumabBiological
As prescribed by the treating clinician
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving nivolumab + relatlimab treatment | Not described Receives: Biological: Nivolumab + relatlimab | |
| Participants receiving nivolumab + ipilimumab treatment | Not described Receives: Biological: Nivolumab + ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant baseline demographics
Measured: Baseline
Participant baseline clinical characteristics
Measured: Baseline
Participant treatment history
Measured: Baseline
Number of doses of index therapies received (neoadjuvant therapies)
Measured: Day 1
Types of surgeries received for melanoma after the index date
Measured: Up to 42-months
Date of last radiation received for melanoma after the index date
Measured: Up to 42-months
Types of regimens received for melanoma post-surgery in the adjuvant setting
Measured: Up to 42-months
Number of doses of adjuvant therapies received (post-surgery)
Measured: Up to 42-months
Dose modifications received by participants
Measured: Up to 42-months
Rationale for dose modifications
Measured: Up to 42-months
Rationale for treatment discontinuation
Measured: Up to 42-months
Overall survival (OS)
Measured: Up to 42-months
Time to treatment discontinuation (TTD)
Measured: Up to 42-months
Duration of treatment (DOT)
Measured: Up to 42-months
Time from neoadjuvant index treatment to adjuvant therapy
Measured: Up to 42-months
Time from neoadjuvant index treatment to surgery
Measured: Up to 42-months
Time from surgery to adjuvant therapy
Measured: Up to 42-months
Pathologic complete response (PCR)
Measured: Up to 42-months
Event-free survival (EFS)
Measured: Up to 42-months
Distant metastasis-free survival (DMFS)
Measured: Up to 42-months
Participant adverse events (AEs)
Measured: Up to 42-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start11 May 2025
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
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
- 100 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
- NCT07091695
- Sponsor's protocol ID
- CA224-1084
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2025
- Last updated
- 12 Nov 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 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab (Nivo+Rela) or Nivolumab+Ipilimumab (Nivo+Ipi)
- ClinicalTrials.gov ID
- NCT07091695
- Acronym / sponsor ID
- CA224-1084
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 May 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 29 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 understand the characteristics of adults diagnosed with with clinically palpable stage III resectable melanoma, the associated treatment patterns for their disease, and outcomes associated with the real-world use of neoadjuvant nivolumab+relatlimab or nivolumab+ipilimumab
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving nivolumab + relatlimab treatment | – | Biological: Nivolumab + relatlimab |
| Participants receiving nivolumab + ipilimumab treatment | – | Biological: Nivolumab + ipilimumab |
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 comprise of adult diagnosed with clinically palpable stage III resectable melanoma in the U.S. managed by physicians in Cardinal Health's OPEN treated with neoadjuvant nivolumab+relatimab or nivolumab+ipilimumab from 18 March 2022.
Key inclusion criteria (3 listed)
- Participants at least 18 years old at diagnosis of clinically palpable stage III resectable melanoma
- Participants treated with nivolumab+relatimab (nivo+rela) or nivolumab+ipilimumab (nivo+ipi) in the neoadjuvant setting
- Participants with at least 6 months of follow-up from initiation of neoadjuvant therapy, unless deceased prior to 6 months of follow-up
Key exclusion criteria (5 listed)
- Participants received nivo+rela or nivo+ipi for clinically palpable stage III resectable melanoma as part of a therapeutic clinical trial
- Participants had history of diagnosis of any malignancy (except for non-melanoma skin cancer) in the last 2 years.
- Participants received adjuvant nivo+rela or adjuvant nivo+ipi after neoadjuvant nivo+ipi
- Participants received adjuvant nivo+ipi after neoadjuvant nivo+rela
- Participants received any systemic therapy prior to the initiation of neoadjuvant nivo+rela or nivo+ipi
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 prescribed by the treating clinician | Biological | Participants receiving nivolumab + relatlimab treatment |
| Nivolumab + ipilimumabAs prescribed by the treating clinician | Biological | Participants receiving nivolumab + ipilimumab treatment |
Primary outcome
Participant baseline demographics
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
Participant treatment history
Time frame: Baseline
Number of doses of index therapies received (neoadjuvant therapies)
Time frame: Day 1
Types of surgeries received for melanoma after the index date
Time frame: Up to 42-months
Date of last radiation received for melanoma after the index date
Time frame: Up to 42-months
Types of regimens received for melanoma post-surgery in the adjuvant setting
Time frame: Up to 42-months
Number of doses of adjuvant therapies received (post-surgery)
Time frame: Up to 42-months
Dose modifications received by participants
Time frame: Up to 42-months
Rationale for dose modifications
Time frame: Up to 42-months
Rationale for treatment discontinuation
Time frame: Up to 42-months
Overall survival (OS)
Time frame: Up to 42-months
Time to treatment discontinuation (TTD)
Time frame: Up to 42-months
Duration of treatment (DOT)
Time frame: Up to 42-months
Time from neoadjuvant index treatment to adjuvant therapy
Time frame: Up to 42-months
Time from neoadjuvant index treatment to surgery
Time frame: Up to 42-months
Time from surgery to adjuvant therapy
Time frame: Up to 42-months
Pathologic complete response (PCR)
Time frame: Up to 42-months
Event-free survival (EFS)
Time frame: Up to 42-months
Distant metastasis-free survival (DMFS)
Time frame: Up to 42-months
Participant adverse events (AEs)
Time frame: Up to 42-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 12 Nov 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 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 3 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 12 Nov 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?
Participant baseline demographics (time frame: Baseline). The study lists 21 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 12 Nov 2025.