This study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

Phase 1

Conditions: Hepatocellular Carcinoma
MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-002740-13-DE

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 908

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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 545
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 363

Exclusion Criteria

-Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
-Prior liver transplant
-Active, known, or suspected autoimmune disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.;Secondary Objective: -Overall Response Rate (ORR)<br>-Progression-Free Survival (PFS)<br>-PD-L1 expression;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: Approximately 33 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1/ Overall Response Rate (ORR)<br>2/ Progression-Free Survival (PFS)<br>3/ PD-L1 expression<br>;Timepoint(s) of evaluation of this end point: 1/, 2/ and 3/: Approximately 33 months