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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Nivolumab; Drug: Sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576509

CA209-459

Details and patient eligibility

About

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

Enrollment: 743 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

743 participants in 2 patient groups

Nivolumab

Experimental group

Description:

Nivolumab specified dose on specified days

Treatment:

Drug: Nivolumab

Sorafenib

Active Comparator group

Description:

Sorafenib specified dose on specified days

Treatment:

Drug: Sorafenib