NCT03205722撤回不适用
The Effectiveness of Nivolumab (OPDIVO®) Monotherapy as First-Line Therapy in Adults With Advanced (Unresectable or Metastatic) Melanoma: An Early Retrospective, Observational Study in Germany
Bristol-Myers Squibb0 个研究点开始时间: 2018年1月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany.
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
- •Adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage III [unresectable] or stage IV skin, ocular, or mucosal melanoma)
- •Newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between June 2015 and June 2016
- •At least 18 years of age at time of treatment decision
排除标准
- •Patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment
- •Patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. In case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known.
- •Patients < 18 years of age at time of treatment initiation
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Overall Survival (OS)
时间窗: Approximately 23 months
OS for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab monotherapy as first-line therapy from date of advanced diagnosis, and from the start of treatment with nivolumab over the first 23 months after treatment initiation, overall.
次要结局
- Distribution of incidence of Adverse Events (AEs)(Approximately 23 months)
- Distribution of severity of Adverse Events (AEs)(Approximately 23 months)
- Distribution of management of Adverse Events (AEs)(Approximately 23 months)
- Distribution of socio-demographic characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy(Approximately 23 months)
- Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy(Approximately 23 months)
- Distribution of Treatment Patterns(Approximately 23 months)
- Distribution of Healthcare Resource Utilization(Approximately 23 months)
- Duration of nivolumab treatment(Approximately 23 months)
- Best Overall Response (BOR) in Patients with brain metastases(Approximately 23 months)
- Distribution of Best Overall Response (BOR) by Melanoma subtype(Approximately 23 months)
- OS from date of advanced diagnosis(Approximately 23 months)
- progression-free survival (PFS)(Approximately 23 months)
- best overall response rate (BORR)(Approximately 23 months)
- best overall response (BOR)(Approximately 23 months)
- Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment(Approximately 23 months)
- Best Overall Response (BOR) in patients greater than or equal to 65 years old(Approximately 23 months)
- Best Overall Response (BOR) in Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2(Approximately 23 months)
- Distribution of Best Overall Response (BOR) by Mutational status(Approximately 23 months)
研究者
相似试验
招募中
4 期
Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable ResponseMelanomaNCT06116461Erasmus Medical Center34
已完成
2 期
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)Hodgkin DiseaseNCT02181738Bristol-Myers Squibb294
已完成
不适用
A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in JapanNon-Small Cell Lung CancerNCT03273790Bristol-Myers Squibb939
已完成
不适用
EFFICACY AND SAFETY OF NIVOLUMAB IN RECURRENT OR METASTATIC HEAD AND NECK CANCER (HNC) PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEWHEAD AND NECK CANCERJPRN-UMIN000032600Bristol-Myers Squibb Ono Pharmaceutical CO.,LTD.256
已完成
3 期
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal CancerEsophageal CancerNCT02569242Ono Pharmaceutical Co. Ltd419