Clinical Trials /

Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC

NCT03412773

Description:

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.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC
  • Official Title: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-301
  • NCT ID: NCT03412773

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DrugSynonymsArms
BGB-A317PD-1 ANTIBODYArm A: BGB-A317 & Safety Run-In Substudy [Japan Only]
SorafenibNexavar, BAY43-9006Arm B: Sorafenib

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.

Trial Arms

NameTypeDescriptionInterventions
Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]Experimental
  • BGB-A317
Arm B: SorafenibActive Comparator
  • Sorafenib

Eligibility Criteria

        Inclusion Criteria:

          -  1. Histologically confirmed diagnosis of HCC

             2. 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

             3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in
             the safety run-in substudy [Japan only])

             4. Measurable disease

             5. Child-Pugh score A

             6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1

             7. Adequate organ function

        Exclusion Criteria:

          -  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
             histology

             2. Tumor thrombus involving main trunk of portal vein or inferior vena cava

             3. Loco-regional therapy to the liver within 28 days before randomization

             4. Clinical evidence of portal hypertension with bleeding esophageal or gastric
             varices at Screening, or within 6 months before randomization

             5. 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

             6. Presence at Screening of active immune deficiency or autoimmune disease and/or
             prior history of any immune deficiency or autoimmune disease that may relapse

             7. 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

             8. History of interstitial lung disease or non-infectious pneumonitis, unless induced
             by radiation therapy

             9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450
             msec at Screening
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:From date of randomization up to 4 years, approximately
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:From date of randomization up to 4 years, approximately
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:From date of randomization up to 4 years, approximately
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:From first determination of an objective response up to 4 years, approximately
Safety Issue:
Description:
Measure:Time to Progression (TTP)
Time Frame:From date of randomization up to 4 years, approximately.
Safety Issue:
Description:
Measure:Health-Related Quality of Life (HRQoL)
Time Frame:From date of enrollment up to 4 years, approximately.
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:From first dose of study treatment up to 4 years, approximately
Safety Issue:
Description:
Measure:Clinical Benefit Rate (CBR)
Time Frame:From first dose of study treatment up to 4 years, approximately
Safety Issue:
Description:
Measure:Percentage of patients with adverse events
Time Frame:From date of screening up to 4 years, approximately.
Safety Issue:
Description:
Measure:Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)
Time Frame:From date of randomization up to 4 years, approximately.
Safety Issue:
Description:
Measure:Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)
Time Frame:From date of randomization up 4 years, approximately
Safety Issue:
Description:
Measure:Safety Run-In Substudy[Japan only]: Duration of Response (DOR)
Time Frame:From date of randomization up 4 years, approximately
Safety Issue:
Description:
Measure:Safety Run-In Substudy[Japan only]: Overall Survival (OS)
Time Frame:From date of randomization up 4 years, approximately
Safety Issue:
Description:
Measure:Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody
Time Frame:From first dose of study treatment up 4 years, approximately
Safety Issue:
Description:
Measure:Percentage of Participants With Clinically Significant Changes in Vital Signs Findings
Time Frame:From date of enrollment up to 4 years, approximately
Safety Issue:
Description:
Measure:Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Time Frame:From date of enrollment up to 4 years, approximately
Safety Issue:
Description:
Measure:Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings
Time Frame:From date of enrollment up to 4 years, approximately
Safety Issue:
Description:
Measure:Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
Time Frame:From date of enrollment up to 4 years, approximately
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • Advanced liver cancer

Last Updated

January 29, 2018