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

NCT ID: NCT07091695

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-11

Study Completion Date

2025-11-06

Brief Summary

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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

Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants receiving nivolumab + relatlimab treatment

Nivolumab + relatlimab

Intervention Type BIOLOGICAL

As prescribed by the treating clinician

Participants receiving nivolumab + ipilimumab treatment

Nivolumab + ipilimumab

Intervention Type BIOLOGICAL

As prescribed by the treating clinician

Interventions

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Nivolumab + relatlimab

As prescribed by the treating clinician

Intervention Type BIOLOGICAL

Nivolumab + ipilimumab

As prescribed by the treating clinician

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Cardinal Health

Dublin, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA224-1084

Identifier Type: -

Identifier Source: org_study_id