Comparative Effectiveness of Different Targeted Therapies for BRAF-mutated Unresectable/Metastatic Melanoma in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 716
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy.
The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.
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
- •Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1,
- •Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1,
- •Age ≥18 years at the time of advanced melanoma diagnosis.
- •Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results.
排除标准
- •• Patients with prior BRAF- or MEK-inhibitor therapy
- •Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)
研究组 & 干预措施
Encorafenib + binimetinib
Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
干预措施: Encorafenib (Drug)
Encorafenib + binimetinib
Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
干预措施: Binimetinib (Drug)
Vemurafenib + Cobimetinib
Vemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle
干预措施: Vemurafenib (Drug)
Vemurafenib + Cobimetinib
Vemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle
干预措施: Cobimetinib (Drug)
Dabrafenib + trametinib
Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)
干预措施: Dabrafenib (Drug)
Dabrafenib + trametinib
Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)
干预措施: Trametinib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (92.7 months)
As per COLUMBUS trial, OS was defined as the time from the date of randomization to the date of death due to any cause; if death was not observed, participants were censored at the date of last contact or the data analysis cut-off date, whichever occurred first. As per Flatiron EHR, OS was defined as the time from the index date to the date of death; participants without a date of death were censored at their last known activity date or the end of the follow-up period, whichever occurred first. Index date in each treatment group was defined as the date of treatment initiation. Kaplan-Meier analyses was used for analysis.
次要结局
未报告次要终点