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

Completed · Phase 3

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT02576509

Run by

Bristol-Myers Squibb

People needed

743

Starts

2015-12-07

Expected to finish

2024-02-07

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Prior liver transplant
• Active, known, or suspected autoimmune disease
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0020 — Los Angeles, California, United States
• Local Institution - 0015 — San Francisco, California, United States
• Local Institution - 0084 — San Francisco, California, United States
• Local Institution - 0061 — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Local Institution - 0083 — New York, New York, United States
• Local Institution - 0093 — New York, New York, United States
• Local Institution - 0016 — Charlotte, North Carolina, United States
• Local Institution - 0095 — Philadelphia, Pennsylvania, United States
• Local Institution - 0019 — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Local Institution - 0017 — San Antonio, Texas, United States
• Scott & White Memorial Hospital And Clinic — Temple, Texas, United States
• Local Institution - 0026 — Seattle, Washington, United States
• University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States
• Local Institution - 0050 — Madison, Wisconsin, United States
• Local Institution - 0005 — Camperdown, New South Wales, Australia
• Local Institution - 0007 — Adelaide, South Australia, Australia
• Local Institution - 0001 — Clayton, Victoria, Australia
• Local Institution - 0002 — Heidelberg, Victoria, Australia
• Local Institution - 0003 — Prahran, Victoria, Australia
• Local Institution - 0008 — Nedlands, Western Australia, Australia
• Local Institution - 0039 — Graz, Austria
• Local Institution - 0038 — Vienna, Austria
• Local Institution - 0066 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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