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Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

NCT02562755

Description:

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
  • Official Title: A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

Clinical Trial IDs

  • ORG STUDY ID: JX594-HEP024
  • NCT ID: NCT02562755

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DrugSynonymsArms
Pexastimogene Devacirepvec (Pexa Vec)JX-594Pexa-Vec followed by Sorafenib
SorafenibNexavarPexa-Vec followed by Sorafenib

Purpose

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

Detailed Description

      This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by
      sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.

      A total of 600 patients will be randomly assigned to 2 treatment arms in a 1:1 ratio (300 in
      each arm) to reach at least 570 evaluable patients.
    

Trial Arms

NameTypeDescriptionInterventions
Pexa-Vec followed by SorafenibExperimentalPexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
  • Pexastimogene Devacirepvec (Pexa Vec)
  • Sorafenib
SorafenibActive ComparatorSorafenib (400 mg twice daily) begins on Day 1.
  • Sorafenib

Eligibility Criteria

        Inclusion Criteria:

          -  Histological/cytological diagnosis of primary HCC

          -  Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American
             Association for the Study of Liver Disease [AASLD] guidelines)

          -  At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using
             a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT]
             scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable
             under imaging-guidance (CT and/or ultrasound)

          -  Child-Pugh Class A

          -  Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

          -  Adequate hematological, hepatic, and renal function:

          -  Additional inclusion criteria exist

        Exclusion Criteria:

          -  Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar
             carcinoma and hepatoblastoma

          -  Symptomatic cardiovascular disease, including but not limited to significant coronary
             artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure
             within the preceding 12 months

          -  Current or past history of cardiovascular disease (e.g.. past history of myocardial
             infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has
             been obtained for study participation

          -  History of moderate or severe ascites, bleeding esophageal varices, hepatic
             encephalopathy or pleural effusions related to liver insufficiency within 6 months of
             screening

          -  Bulky disease patients - tumors encompassing >50% of the liver volume and / or
             inferior vena cava invasion

          -  Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or
             immune-suppressive medication including high-dose corticosteroids

          -  Ongoing severe inflammatory skin condition (as determined by the Investigator)
             requiring medical treatment

          -  History of severe eczema (as determined by the Investigator) requiring medical
             treatment

          -  Additional exclusion criteria exist
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival
Time Frame:From the date of randomization to the date of death due to any cause up to study completion (approximately 53 months).
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Time to Progression (TTP)
Time Frame:From date of randomization to the date of first documented radiographic tumor progression up to 53 months.
Safety Issue:
Description:
Measure:Progression Free Survival (PFS)
Time Frame:From date of randomization to the date of first documented radiographic tumor progression or death, whichever occurs first, assessed up to 53 months.
Safety Issue:
Description:
Measure:Overall Response Rate (ORR)
Time Frame:From the date of randomization until disease progression, up to 53 months.
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:From date of randomization to end of participation in the study up to 53 months.
Safety Issue:
Description:Proportion of patients whose best overall response during their participation in the study is either CR, PR, or stable disease (SD).
Measure:Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame:From date of randomization to end of participation in the study, up to 53 months.
Safety Issue:
Description:Assessed by the NCI CTCAE (version 4.03). Incidence of AEs and SAEs will be reported.
Measure:Time to Symptomatic Progression (TSP)
Time Frame:Time from randomization until the first documented event of symptomatic progression, up to 53 months..
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:SillaJen, Inc.

Trial Keywords

  • Hepatocellular Carcinoma (HCC)
  • Pexastimogene Devacirepvec (Pexa-Vec)
  • Sorafenib
  • GM-CSF therapy
  • Thymidine Kinase-Deactivated Vaccinia Virus
  • Oncology
  • Recombinant Vaccinia Virus
  • Oncolytic Virus Therapy
  • Oncolytic virotherapy

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