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

NCT07079644 | Completed FDA Drug

• 1 other identifier: CA224-1098
• Study Type: observational
• Target: 678
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Melanoma

Keywords

Advanced melanoma

Outcome Measures

Primary Outcomes (7)

• Demographics

  Baseline

• Clinical characteristics: Location of metastatic sites

  Baseline

• Clinical characteristics: Lactate dehydrogenate (LDH) test results

  Baseline

• Clinical characteristics: BRAF status

  Baseline

• 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

Study Arms (4)

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

Interventions

Nivolumab + Relatlimab BIOLOGICAL

As per product label

1L Nivolumab + Relatlimab cohort

Nivolumab + Ipilimumab BIOLOGICAL

As per product label

1L Nivolumab + Ipilimumab cohort

Immunotherapy monotherapy BIOLOGICAL

As per product label

1L Immunotherapy monotherapy cohort

BRAF/MEK inhibitors DRUG

As per product label

1L BRAF/MEKs inhibitors cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol Myers Squibb

Princeton, New Jersey, 08540-4715, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Nivolumab; relatlimab; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 23, 2025
• Study Start: November 29, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)