Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab (Nivo+Rela) or Nivolumab+Ipilimumab (Nivo+Ipi)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Participant baseline demographics
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Participants receiving nivolumab + relatlimab treatment
干预措施: Nivolumab + relatlimab (Biological)
Participants receiving nivolumab + ipilimumab treatment
干预措施: Nivolumab + ipilimumab (Biological)
结局指标
主要结局
Participant baseline demographics
时间窗: Baseline
Participant treatment history
时间窗: Baseline
Event-free survival (EFS)
时间窗: Up to 42-months
Participant baseline clinical characteristics
时间窗: Baseline
Number of doses of index therapies received (neoadjuvant therapies)
时间窗: Day 1
Rationale for dose modifications
时间窗: Up to 42-months
Rationale for treatment discontinuation
时间窗: Up to 42-months
Overall survival (OS)
时间窗: Up to 42-months
Time to treatment discontinuation (TTD)
时间窗: Up to 42-months
Duration of treatment (DOT)
时间窗: Up to 42-months
Time from neoadjuvant index treatment to adjuvant therapy
时间窗: Up to 42-months
Types of surgeries received for melanoma after the index date
时间窗: Up to 42-months
Number of doses of adjuvant therapies received (post-surgery)
时间窗: Up to 42-months
Date of last radiation received for melanoma after the index date
时间窗: Up to 42-months
Types of regimens received for melanoma post-surgery in the adjuvant setting
时间窗: Up to 42-months
Dose modifications received by participants
时间窗: Up to 42-months
Time from neoadjuvant index treatment to surgery
时间窗: Up to 42-months
Distant metastasis-free survival (DMFS)
时间窗: Up to 42-months
Time from surgery to adjuvant therapy
时间窗: Up to 42-months
Pathologic complete response (PCR)
时间窗: Up to 42-months
Participant adverse events (AEs)
时间窗: Up to 42-months
次要结局
未报告次要终点