An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.
NOTE: Global recruitment is complete but enrollment is ongoing for the China sub-study.
The Primary Completion Date for ORR will be reached July 2017. The Completion Date for all Primary Outcome Measures is expected in October 2018.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)|
- Overall Survival (OS) [ Time Frame: Approximately 33 months ]
- Overall Response Rate (ORR) [ Time Frame: Approximately 33 months ]
- Progression-Free Survival (PFS) [ Time Frame: Approximately 33 months ]
- Programmed death (PD)-L1 expression [ Time Frame: Approximately 33 months ]
|Actual Study Start Date:||November 25, 2015|
|Estimated Study Completion Date:||June 22, 2019|
|Estimated Primary Completion Date:||October 1, 2018 (Final data collection date for primary outcome measure)|
Nivolumab specified dose on specified days
Active Comparator: Sorafenib
Sorafenib specified dose on specified days
Please refer to this study by its ClinicalTrials.gov identifier: NCT02576509
|Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:||Clinical.Trials@bms.com|
|Contact: First line of the email MUST contain NCT# and Site #.|
Show 138 Study Locations
|Study Director:||Bristol Myers Squibb||Bristol-Myers Squibb|