| 项目编号 |
PRJCA011366 |
| 项目标题 |
A Randomized Phase 3 Study of Nivolumab plus Ipilimumab or Nivolumab Combined with Fluorouracil plus Cisplatin versus Fluorouracil plus Cisplatin in Subjects with Advanced ESCC |
| 涉及领域 |
Medical |
| 数据类型 |
Biomaker (PD-L1) and Metabolic (PK and IMG)
|
| 物种名称 |
Homo sapiens
|
| 描述信息 |
CA209648 is a randomized, global Phase 3 study of nivolumab plus ipilimumab or nivolumab in combination with fluorouracil plus cisplatin versus fluorouracil and cisplatin chemotherapy as first line-therapy in unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This study will determine if nivolumab plus ipilimumab and nivolumab combined with fluorouracil plus cisplatin improve overall survival (OS) and/or progression free survival (PFS) over fluorouracil and cisplatin standard of care chemotherapy in subjects with ESCC whose tumors express PD-L1. Additional objectives include further characterization of the efficacy, adverse event profile, pharmacokinetics, patient reported outcomes and potential predictive biomarkers of nivolumab in combination with ipilimumab or nivolumab in combination with fluorouracil and cisplatin in subjects with ESCC. |
| 样品范围 |
Multiisolate |
| 发布日期 |
2022-08-22 |
| 项目资金来源 |
| 机构 |
项目类型 |
授权项目ID |
授权项目名称 |
| Bristol-Myers Squibb (China) Investment Co., Ltd., Bristol-Myers Squibb Company
|
|
2017L04842/2017L04843
|
|
|
|
| 提交者 |
Jianming
Xu (jianmingxu2014@163.com)
|
| 提交单位 |
Chinese PLA General Hospital (CPLAGH) |
| 提交日期 |
2022-08-22 |
