Accession |
PRJCA011148 |
Title |
A Phase III, Randomized, Open Label Trial of Nivolumab in combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in unresectable Pleural Mesothelioma |
Relevance |
Medical |
Data types |
biomaker (PD-L1, MDSC); metabolic (PK, IMG)
|
Organisms |
Homo sapiens
|
Description |
CA209743 is a randomized, open-label, global Phase 3 trial of nivolumab (also known as BMS-936558) in combination with ipilimumab (also known as BMS-734016) versus pemetrexed plus cisplatin or carboplatin as first line-therapy in unresectable malignant pleural mesothelioma (MPM). The primary objective of the study will be to determine if nivolumab plus ipilimumab regimen improves progression free survival (PFS) and/or overall survival (OS) over standard of care chemotherapy in this subject population. The secondary objectives include further characterization of the efficacy, adverse event profile, pharmacokinetics, patient reported outcomes, and potential predictive biomarkers of nivolumab combined with ipilimumab in subjects with MPM. |
Sample scope |
Multiisolate |
Release date |
2022-08-11 |
Grants |
Agency |
program |
Grant ID |
Grant title |
Bristol-Myers Squibb (China) Investment Co., Ltd.; Bristol-Myers Squibb Company
|
|
2017L04298/2017L04299
|
|
|
Submitter |
shun
Lu (shunlu_shchest@sina.com)
|
Organization |
Shanghai Chest Hospital |
Submission date |
2022-08-11 |