NCT02990611已完成不适用
A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,087 人开始时间: 2016年12月6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
- 1,087
- 试验地点
- 1
- 主要终点
- Relapse free survival (RFS) of adjuvant nivolumab therapy
研究概览
简要总结
The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.
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
- •For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- •Advanced melanoma (Stage III/Stage IV)
- •Histologically confirmed diagnosis
- •Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken
- •For Cohort 3: (Recruitment ended by 08/31/2020)
- •Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
- •Treatment decision for adjuvant nivolumab therapy has already been taken
排除标准
- •For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- •Current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- •Previous treatment with nivolumab, for nivolumab monotherapy cohort only
- •Current active participation in an interventional clinical trial
- •For Cohort 3: (Recruitment ended by 08/31/2020)
- •Current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- •Current active participation in an interventional clinical trial
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Relapse free survival (RFS) of adjuvant nivolumab therapy
时间窗: 5 years
Overall survival (OS) of nivolumab/ipilimumab combination therapy
时间窗: 5 years
次要结局
- Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy(5 years)
- Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy(5 years)
- Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy(5 years)
- Overall survival (OS) of nivolumab monotherapy(5 years)
- Distribution of sociodemographic characteristics: Age(5 years)
- Distribution of sociodemographic characteristics: BMI(5 years)
- Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy(5 years)
- Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated)(5 years)
- Distribution of clinical characteristics: Mutation status(5 years)
- Distribution of clinical characteristics: Concomitant medication(5 years)
- Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest(5 years)
- Duration of response of monotherapy and combination therapy(Up to 5 years)
- Distribution of sociodemographic characteristics: Gender(5 years)
- Distribution of clinical characteristics: Initial diagnosis of melanoma(5 years)
- Distribution of clinical characteristics: Diagnosis of advanced melanoma(5 years)
- Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease(5 years)
- Distribution of clinical characteristics: Clinical code and staging melanoma subtypes(5 years)
- Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale(5 years)
- Distribution of treatment patterns: Current treatment details(5 years)
- Incidence of adverse events (AEs)(5 years)
- Distribution of management of adverse events (AEs)(5 years)
- Distribution of clinical characteristics: Comorbidities(5 years)
- Distribution of clinical characteristics: Diagnostic procedures(5 years)
- Distribution of clinical characteristics: History of cancer(5 years)
- Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)(5 years)
- Distribution of treatment patterns: Type of treatment previously received(5 years)
- Distribution of treatment patterns: Stage of melanoma(5 years)
- European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)(5 years)
- Severity of adverse events (AEs)(5 years)
- Distribution of clinical characteristics: Medical history(5 years)
- Overall survival (OS) of adjuvant therapy(5 years)
研究者
研究点 (1)
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