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An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02576509
Recruitment Status : Active, not recruiting
First Posted : October 15, 2015
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

October 13, 2015
October 15, 2015
April 10, 2018
November 25, 2015
October 16, 2018   (Final data collection date for primary outcome measure)
Overall Survival (OS) [ Time Frame: Approximately 33 months ]
  • Time To Progression (TTP) [ Time Frame: Approximately 18 months ]
    It is defined as the time from the date of randomization to the date of the first objectively documented tumor progression.
  • Overall Survival (OS) [ Time Frame: Approximately 33 months ]
    It is defined as the time from the date of randomization to the date of death due to any cause.
Complete list of historical versions of study NCT02576509 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 33 months ]
  • Programmed death (PD)-L1 expression [ Time Frame: Approximately 33 months ]
  • Overall Response Rate (ORR) [ Time Frame: Approximately 33 months ]
  • Overall Response Rate (ORR) [ Time Frame: Approximately 33 months ]
    It is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a Complete response (CR) or Partial response (PR).
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 33 months ]
    It is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by blinded independent central review (BICR) according to RECIST 1.1or death due to any cause.
  • Programmed death (PD)-L1 expression [ Time Frame: Approximately 33 months ]
Not Provided
Not Provided
 
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
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)
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: Nivolumab
  • Drug: Sorafenib
  • Experimental: Nivolumab
    Nivolumab specified dose on specified days
    Intervention: Drug: Nivolumab
  • Active Comparator: Sorafenib
    Sorafenib specified dose on specified days
    Intervention: Drug: Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
726
Same as current
December 31, 2019
October 16, 2018   (Final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
  • Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
  • Child-Pugh Class A
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Prior liver transplant
  • Active, known, or suspected autoimmune disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   China,   Czechia,   France,   Germany,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Czech Republic
 
NCT02576509
CA209-459
Yes
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP