NCT04550247进行中（未招募）不适用
A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2020年9月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Relapse-Free Survival (RFS)
研究概览
简要总结
This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.
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
- •Participants with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease
- •Decision to treat with adjuvant nivolumab therapy has already been taken
- •Participants who provide oral informed consent to participate in the study
排除标准
- •Any participant with a current diagnosis of persisting advanced melanoma
- •Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- •Any participants currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
- •Pregnant women
- •Person under guardianship
- •Other protocol defined inclusion/exclusion criteria apply
结局指标
主要结局
Relapse-Free Survival (RFS)
时间窗: up to 60 months
次要结局
- Assessment of sociodemographic characteristics(Up to 60 months)
- Frequency of nivolumab therapy: number of dosing(Up to 60 months)
- Relapse-Free Survival 2 (RFS2)(Up to 60 months)
- Assessment of clinical characteristics(Up to 60 months)
- Overall Survival (OS)(Up to 60 months)
- Frequency of Nivolumab: pattern of use(Up to 60 months)
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: incidence(Up to 60 months)
- Assessment of health related quality of life(Up to 60 Months)
- Distant Metastatasis-Free Survival (DMFS)(Up to 60 months)
- Progression Free Survival (PFS)(Up to 60 months)
- Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response(Up to 60 months)
- Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS(Up to 60 months)
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome(Up to 60 months)
- Frequency of nivolumab therapy: number of infusions(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: management(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs(Up to 60 months)
- Describe the use of subsequent therapies after relapse following adjuvant nivolumab(Up to 60 months)
- Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate(Up to 60 months)
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: grade(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: type(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs(Up to 60 months)
- Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2(Up to 60 months)
- Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS(Up to 60 months)
- Characteristics of nivolumab adjuvant safety profile: outcome(Up to 60 months)
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type(Up to 60 months)
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management(Up to 60 months)
研究者
研究点 (1)
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