Melanoma
Conditions
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
Interventions
BIOLOGICALNivolumab + relatlimab
As prescribed by the treating clinician
BIOLOGICALNivolumab + ipilimumab
As prescribed by the treating clinician
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed