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Trial record 15 of 17 for:    JX-594

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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by SillaJen, Inc.
Sponsor:
Information provided by (Responsible Party):
SillaJen, Inc.
ClinicalTrials.gov Identifier:
NCT02562755
First received: September 24, 2015
Last updated: July 18, 2017
Last verified: July 2017
  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.

Condition Intervention Phase
Hepatocellular Carcinoma (HCC) Biological: Pexastimogene Devacirepvec (Pexa Vec) Drug: Sorafenib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by SillaJen, Inc.:

Primary Outcome Measures:
  • 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). ]

Secondary Outcome Measures:
  • 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.. ]

Other Outcome Measures:
  • 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. ]

Estimated Enrollment: 600
Study Start Date: October 2015
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: Sorafenib
Sorafenib (400 mg twice daily) begins on Day 1.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02562755

Contacts
Contact: Stephanie Fairbairn (415) 530-4998 patient_inquiry@sillajen.com

  Show 86 Study Locations
Sponsors and Collaborators
SillaJen, Inc.
Investigators
Study Director: James M Burke, MD SillaJen Biotherapeutics, Inc.
  More Information

Responsible Party: SillaJen, Inc.
ClinicalTrials.gov Identifier: NCT02562755     History of Changes
Other Study ID Numbers: JX594-HEP024
Study First Received: September 24, 2015
Last Updated: July 18, 2017

Keywords provided by SillaJen, Inc.:
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Vaccinia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2017