NCT05165264进行中（未招募）不适用
A National, Prospective, Non-interventional Study (NIS) of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Patients With HER2 Negative Advanced or Metastatic Gastric, Gastro-oesophageal Junction or Oesophageal Adenocarcinoma Whose Tumours Express PD-L1 With a CPS ≥5
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年2月16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
- 600
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this observational study is to assess the effectiveness and safety of nivolumab in participants with previously untreated advanced or metastatic Gastric Cancer (GC), Gastro-oesophageal Junction (GEJ) Adenocarcinoma, or Oesophageal Adenocarcinoma (EAC).
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
- •Diagnosis of HER2 negative advanced or metastatic HER2-negative GC, GEJ adenocarcinoma or EAC whose tumours express PD-L1 with a CPS ≥ 5
- •Whose physician has decided to start a treatment with nivolumab (according to the German marketing authorization) for the treatment of GC, GEJ adenocarcinoma or EAC and prior to study participation
排除标准
- •Previous malignancy within 3 years or concomitant malignancy, except: those with a 5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer.
- •Participants currently included in an interventional clinical trial for their advanced or metastatic GC, GEJ adenocarcinoma or EAC. Participants who have completed their participation in an interventional trial or who are not receiving any study drug anymore and who are only in the follow-up Phase for OS can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.
结局指标
主要结局
Overall Survival (OS)
时间窗: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
次要结局
- Progression-free survival (PFS)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
- Overall response rate (ORR)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
- Duration of response(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
- Incidence of Adverse Events (AEs)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
- Overall Survival (OS)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
- OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS)(From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab TherapyMelanomaNCT02990611Bristol-Myers Squibb1,087
已完成
不适用
An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in AustraliaMelanomaNCT04146324Bristol-Myers Squibb150
招募中
Unknown
A prospective observational study of nivolumab plus chemotherapy for advanced gastric cancer using CyberOncology (WJOG15922G)JPRN-UMIN000049928West Japan Oncology Group100
已完成
3 期
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver CancerCancer, HepatocellularNCT04340193Bristol-Myers Squibb26
已完成
2 期
A Study of Nivolumab in Selected Uterine Cancer PatientsUterine CancerEndometrial CarcinomaCarcinosarcomaUndifferentiated SarcomaHigh Grade Endometrial Stromal SarcomaLeiomyosarcomaClear Cell CarcinomaNCT03241745Memorial Sloan Kettering Cancer Center35