Purpose

This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1. Histologically confirmed diagnosis of HCC
  • Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
  • No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])
  • Measurable disease
  • Child-Pugh score A
  • Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Adequate organ function

Exclusion Criteria

  • 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  • Tumor thrombus involving main trunk of portal vein or inferior vena cava
  • Loco-regional therapy to the liver within 28 days before randomization
  • Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
  • Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
  • Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
  • Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
  • History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
  • QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]
  • Drug: BGB-A317
    BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)
    Other names:
    • PD-1 ANTIBODY
Active Comparator
Arm B: Sorafenib
  • Drug: Sorafenib
    Sorafenib: 400 mg twice daily (BID), oral dosing
    Other names:
    • Nexavar, BAY43-9006

Recruiting Locations

Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee 37232

More Details

NCT ID
NCT03412773
Status
Recruiting
Sponsor
BeiGene

Study Contact

Ginny Paton, Executive Director, Clinical Science
1 (877) 828-5568
clinicaltrials@beigene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.