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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Biological: Nivolumab + ipilimumab; Biological: Nivolumab + relatlimab

Study type: Observational

Funder types: Industry

Identifiers

NCT07091695

CA224-1084

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Participants receiving nivolumab + relatlimab treatment

Treatment:

Biological: Nivolumab + relatlimab

Participants receiving nivolumab + ipilimumab treatment

Treatment:

Biological: Nivolumab + ipilimumab