Real World Outcomes of Nivolumab + Relatlimab in Patients With Advanced Melanoma in the Flatiron Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 678
- 试验地点
- 1
- 主要终点
- Clinical characteristics: BRAF status
研究概览
简要总结
The purpose of this study is to investigate the real-world clinical outcomes of individuals that have been diagnosed with advanced melanoma who were treated with Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy
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 in the advanced melanoma cohort
- •Participants included in the cohort by Flatiron criteria of: cutaneous melanoma with pathologic stages III or IV, either at initial diagnosis or via local or distant recurrence, and at least two clinic encounters evident in the database
- •Participants receiving Nivolumab + Relatlimab between March 18, 2022 and September 30, 2024 or other therapies (Nivolumab + Ipilimumab, immunotherapy monotherapy, BRAF/MEK inhibitors) between March 18, 2022 and November 30, 2024 (or date of the most recent data cut off)
- •Participants ≥18 years old on index date
- •Participants with ≥1 month of medical data after the index date (inclusive), unless patient died within this period
排除标准
- •Participants with diagnosis of other primary cancers prior to the index date
- •Participants receiving medication in a clinical trial at any time prior to, on or after index date
研究组 & 干预措施
1L Nivolumab + Relatlimab cohort
干预措施: Nivolumab + Relatlimab (Biological)
1L Nivolumab + Ipilimumab cohort
干预措施: Nivolumab + Ipilimumab (Biological)
1L Immunotherapy monotherapy cohort
干预措施: Immunotherapy monotherapy (Biological)
1L BRAF/MEKs inhibitors cohort
干预措施: BRAF/MEK inhibitors (Drug)
结局指标
主要结局
Clinical characteristics: BRAF status
时间窗: Baseline
Clinical characteristics: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
时间窗: Baseline
Overall survival (OS)
时间窗: Up to 3-years
Real-world progression-free survival (rwPFS)
时间窗: Up to 3-years
Demographics
时间窗: Baseline
Clinical characteristics: Location of metastatic sites
时间窗: Baseline
Clinical characteristics: Lactate dehydrogenate (LDH) test results
时间窗: Baseline
次要结局
未报告次要终点