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

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ClinicalTrials.gov Identifier: NCT02562755
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
SillaJen, Inc.

September 24, 2015
September 29, 2015
August 6, 2018
October 2015
October 2018   (Final data collection date for primary outcome 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). ]
Same as current
Complete list of historical versions of study NCT02562755 on ClinicalTrials.gov Archive Site
  • Time to Progression (TTP) [ Time Frame: From date of randomization to the date of first documented radiographic tumor progression up to 53 months. ]
  • 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. ]
  • Overall Response Rate (ORR) [ Time Frame: From the date of randomization until disease progression, up to 53 months. ]
  • Disease Control Rate (DCR) [ Time Frame: From date of randomization to end of participation in the study up to 53 months. ]
    Proportion of patients whose best overall response during their participation in the study is either CR, PR, or stable disease (SD).
  • 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. ]
    Assessed by the NCI CTCAE (version 4.03). Incidence of AEs and SAEs will be reported.
  • Time to Symptomatic Progression (TSP) [ Time Frame: Time from randomization until the first documented event of symptomatic progression, up to 53 months.. ]
Same as current
  • Exploratory Outcomes - Duration of Overall Response (DOR) [ Time Frame: From date of first documented response (CR or PR) to date of first documented disease progression or death due to underlying cancer, up to 53 months. ]
  • Exploratory Outcomes - Time to Initial Response (TIR) [ Time Frame: From date of randomization to date of first documented response (CR or PR), up to 53 months. ]
Same as current
 
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma (HCC)
  • Biological: Pexastimogene Devacirepvec (Pexa Vec)
    Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
    Other Name: JX-594
  • Drug: Sorafenib

    Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.

    Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.

    Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.

    Other Name: Nexavar
  • Experimental: Pexa-Vec followed by Sorafenib
    Pexa-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.
    Interventions:
    • Biological: Pexastimogene Devacirepvec (Pexa Vec)
    • Drug: Sorafenib
  • Active Comparator: Sorafenib
    Sorafenib (400 mg twice daily) begins on Day 1.
    Intervention: Drug: Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Same as current
October 2019
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Stephanie Fairbairn (415) 530-4998 patient_inquiry@sillajen.com
Australia,   Canada,   China,   France,   Germany,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   New Zealand,   Portugal,   Singapore,   Taiwan,   Thailand,   United Kingdom,   United States
 
 
NCT02562755
JX594-HEP024
Yes
Not Provided
Not Provided
SillaJen, Inc.
SillaJen, Inc.
Not Provided
Study Director: James M Burke, MD SillaJen Biotherapeutics, Inc.
SillaJen, Inc.
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP