Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab

NCT07091695 | Completed FDA Drug

• 1 other identifier: CA224-1084
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (21)

• Participant baseline demographics

  Baseline

• Participant baseline clinical characteristics

  Baseline

• Participant treatment history

  Baseline

• Number of doses of index therapies received (neoadjuvant therapies)

  Day 1

• Types of surgeries received for melanoma after the index date

  Up to 42-months

• Date of last radiation received for melanoma after the index date

  Up to 42-months

• Types of regimens received for melanoma post-surgery in the adjuvant setting

  Up to 42-months

• Number of doses of adjuvant therapies received (post-surgery)

  Up to 42-months

• Dose modifications received by participants

  Up to 42-months

• Rationale for dose modifications

  Up to 42-months

• Rationale for treatment discontinuation

  Up to 42-months

• Overall survival (OS)

  Up to 42-months

• Time to treatment discontinuation (TTD)

  Up to 42-months

• Duration of treatment (DOT)

  Up to 42-months

• Time from neoadjuvant index treatment to adjuvant therapy

  Up to 42-months

• Time from neoadjuvant index treatment to surgery

  Up to 42-months

• Time from surgery to adjuvant therapy

  Up to 42-months

• Pathologic complete response (PCR)

  Up to 42-months

• Event-free survival (EFS)

  Up to 42-months

• Distant metastasis-free survival (DMFS)

  Up to 42-months

• Participant adverse events (AEs)

  Up to 42-months

Study Arms (2)

Participants receiving nivolumab + relatlimab treatment

Biological: Nivolumab + relatlimab

Participants receiving nivolumab + ipilimumab treatment

Biological: Nivolumab + ipilimumab

Interventions

Nivolumab + relatlimab BIOLOGICAL

As prescribed by the treating clinician

Participants receiving nivolumab + relatlimab treatment

Nivolumab + ipilimumab BIOLOGICAL

As prescribed by the treating clinician

Participants receiving nivolumab + ipilimumab treatment

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 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Cardinal Health

Dublin, Ohio, 43017, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; relatlimab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

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: July 22, 2025
• First Posted: July 29, 2025
• Study Start: May 11, 2025
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)