| Accession |
PRJCA011366 |
| Title |
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 |
| Relevance |
Medical |
| Data types |
Biomaker (PD-L1) and Metabolic (PK and IMG)
|
| Organisms |
Homo sapiens
|
| Description |
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. |
| Sample scope |
Multiisolate |
| Release date |
2022-08-22 |
| Grants |
| Agency |
program |
Grant ID |
Grant title |
| Bristol-Myers Squibb (China) Investment Co., Ltd., Bristol-Myers Squibb Company
|
|
2017L04842/2017L04843
|
|
|
|
| Submitter |
Jianming
Xu (jianmingxu2014@163.com)
|
| Organization |
Chinese PLA General Hospital (CPLAGH) |
| Submission date |
2022-08-22 |
