NCT03448497已完成不适用
Retrospective Chart Review Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2017年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- Best Overall Response (BOR) rate
研究概览
简要总结
The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination 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
- •Patient has medical chart documentation of advanced (unresectable or metastatic) melanoma.
- •Patient initiated a first-line therapy for the treatment of advanced melanoma during the eligibility period (01 July 2016 to 01 July 2017; index event).
- •Patient did not receive systemic treatment for their advanced (unresectable or metastatic) melanoma prior to index event
- •Patient initiated first-line therapy at least six months before the date their chart abstraction initiated
排除标准
- •Patient was enrolled in an investigational drug clinical trial or participating in medical research judged to directly affect how the patient was being monitored/treated while receiving first-line therapy
- •Patient had another active concurrent malignancy other than advanced melanoma, which required systemic treatment at the time of index event
- •Part or all of the patient's first-line treatment was received at a different site and the patient's medical chart pertaining to this care is not accessible
- •Patient medical chart is missing, empty, or not retrievable
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Best Overall Response (BOR) rate
时间窗: Up to 18 months
In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
次要结局
- Distribution of PD-L1 threshold(At baseline)
- Distribution of AESI management(up to 18 months)
- Prior melanoma treatment history(At baseline)
- Distribution of subsequent therapy line treatment patterns(Up to 18 months)
- melanoma related healthcare resource utilization (HCRU)(Up to 18 months)
- Eastern Cooperative Oncology Group (ECOG) score(Up to 18 months)
- Progression Free Survival (PFS)(Up to 18 months)
- Overall Survival (OS)(Up to 18 months)
- Incidence of adverse events of Special interest(AESI)(Up to 18 months)
- Incidence of serious adverse events (SAE)(Up to 18 months)
- Distribution of patient demographic characteristics(At baseline)
- Serum concentration of lactate dehydrogenase (LDH)(At baseline)
- Distribution of first-line treatment patterns(Up to 18 months)
- Treatment-Free Interval (TFI)(Up to 18 months)
研究者
研究点 (1)
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