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

Completed

• Conditions: Advanced Melanoma
• Interventions: Biological: Nivolumab + Relatlimab; Biological: Nivolumab + Ipilimumab; Biological: Immunotherapy monotherapy; Drug: BRAF/MEK inhibitors

• Registration Number: NCT07079644
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-29
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Study First Submitted: 2025-06-10
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 678

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1L Nivolumab + Relatlimab cohort	Nivolumab + Relatlimab	-
1L Nivolumab + Ipilimumab cohort	Nivolumab + Ipilimumab	-
1L Immunotherapy monotherapy cohort	Immunotherapy monotherapy	-
1L BRAF/MEKs inhibitors cohort	BRAF/MEK inhibitors	-

Primary Outcome Measures

Name	Time	Method
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
Demographics	Baseline
Clinical characteristics: Location of metastatic sites	Baseline
Clinical characteristics: Lactate dehydrogenate (LDH) test results	Baseline

Trial Locations

Locations (1)

Bristol Myers Squibb; 🇺🇸 Princeton, New Jersey, United States