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Outcomes of Nivolumab in Combination With Relatlimab in Patients With Advanced Melanoma in the Flatiron Database

Real World Outcomes of Nivolumab + Relatlimab in Patients With Advanced Melanoma in the Flatiron Database

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07079644
Enrollment
678
Registered
2025-07-23
Start date
2024-11-29
Completion date
2025-03-31
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Melanoma

Keywords

Advanced melanoma

Brief 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

Interventions

BIOLOGICALNivolumab + Relatlimab

As per product label

BIOLOGICALNivolumab + Ipilimumab

As per product label

BIOLOGICALImmunotherapy monotherapy

As per product label

DRUGBRAF/MEK inhibitors

As per product label

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
DemographicsBaseline
Clinical characteristics: Location of metastatic sitesBaseline
Clinical characteristics: Lactate dehydrogenate (LDH) test resultsBaseline
Clinical characteristics: BRAF statusBaseline
Clinical characteristics: Eastern Cooperative Oncology Group Performance Status (ECOG PS)Baseline
Overall survival (OS)Up to 3-years
Real-world progression-free survival (rwPFS)Up to 3-years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026