NCT04146324已完成不适用
A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年12月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Percentage of Participants with Relapse-Free Survival (RFS)
研究概览
简要总结
This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease
- •Decision to treat with adjuvant nivolumab therapy has already been taken
- •Ability to provide written informed consent to participate in the study
排除标准
- •Adults with a current diagnosis of persisting advanced melanoma
- •Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Adjuvant nivolumab therapy
Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia
干预措施: nivolumab (Drug)
结局指标
主要结局
Percentage of Participants with Relapse-Free Survival (RFS)
时间窗: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
The time between the date of randomisation and the date of first recurrence, new primary melanoma, or death due to any cause, whichever occurred first.
次要结局
- Percentage of Participants with Distant Metastasis-Free Survival (DMFS)(Up to 5 years post treatment initiation with adjuvant nivolumab therapy)
- Description of sociodemographic profile of participants(At treatment initiation with adjuvant nivolumab therapy)
- HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30)(Up to 5 years post treatment initiation with adjuvant nivolumab therapy)
- Overall Survival (OS)(Up to 5 years post treatment initiation with adjuvant nivolumab therapy)
- HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire(Up to 5 years post treatment initiation with adjuvant nivolumab therapy)
- Description of clinical characteristics of participants(At treatment initiation with adjuvant nivolumab therapy)
- Description of nivolumab pattern of use(At treatment initiation with adjuvant nivolumab therapy)
- Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D)(Up to 5 years post treatment initiation with adjuvant nivolumab therapy)
- Number of participants experiencing non-immune-related AEs(Up to 5 years post treatment initiation with adjuvant nivolumab therapy)
- Prior medical history of participants(At treatment initiation with adjuvant nivolumab therapy)
- Participants' socioeconomic status as assessed by their highest education level(At treatment initiation with adjuvant nivolumab therapy)
- Description of care received as assessed by Healthcare Resource Utlization(During, and up to 5 years post discontinuation of nivolumab use)
- Number of participants experiencing immune-related Adverse Events (AEs)(Up to 5 years post treatment initiation with adjuvant nivolumab therapy)
研究者
研究点 (2)
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