| Accession |
PRJCA013377 |
| Title |
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma |
| Relevance |
Medical |
| Data types |
PD-L1 /PK/IMG data
|
| Organisms |
Homo sapiens
|
| Description |
Based on the high unmet medical need, the strong scientific rationale for inhibiting the PD-1 pathway, and the overall safety profile of nivolumab across multiple tumor types, the overall benefits of adjuvant nivolumab monotherapy in subjects with high risk IUC outweigh the potential clinical risks. Research Hypothesis: Treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all randomized patients and in patients with PD-L1 expressing tumors (membranous staining in 1%) who are at high risk of recurrence after undergoing radical resection of invasive urothelial carcinoma (IUC). |
| Sample scope |
Multiisolate |
| Release date |
2022-11-21 |
| Grants |
| Agency |
program |
Grant ID |
Grant title |
| Bristol-Myers Squibb (China) Investment Co., Ltd., Bristol-Myers Squibb Company
|
|
2017L04071
|
|
|
|
| Submitter |
Dingwei
Ye (fuscc2012@163.com)
|
| Organization |
Shanghai Tumor Hospital |
| Submission date |
2022-11-21 |
