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

December 11, 2020 updated by: SillaJen, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 459 patients were randomly assigned to 2 treatment arms- 234 patients in the Pexa-Vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Site No. 8409
      • Adelaide, Australia
        • Site No. 8412
      • Brisbane, Australia
        • Site No. 8403
      • Camperdown, Australia
        • Site No. 8401
      • Clayton, Australia
        • Site No. 8407
      • Concord, Australia
        • Site No. 8406
      • Fitzroy, Australia
        • Site No. 8408
      • Footscray, Australia
        • Site No. 8405
      • Heidelberg, Australia
        • Site No. 8414
      • Melbourne, Australia
        • Site No. 8411
      • Parkville, Australia
        • Site No. 8402
      • Perth, Australia
        • Site No. 8415
      • Sydney, Australia
        • Site No. 8413
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • China
      • Changchun, China
        • Site 8829
      • Changsha, China
        • Site No. 8821
      • Fuzhou, China
        • Site 8811
      • Fuzhou, China
        • Site 8820
      • Guangdong, China
        • Site No.8816
      • Guangzhou, China
        • Site 8827
      • Guangzhou, China
        • Site No.8828
      • Hangzhou, China
        • Site 8832
      • Harbin, China
        • Site No. 8802
      • Hefei, China
        • Site 8805
      • Hefei, China
        • Site No. 8808
      • Hefei, China
        • Site No.8815
      • Nanjing, China
        • Site No. 8801
      • Qingdao, China
        • Site 8833
      • Shanghai, China
        • Site 8806
      • Shanghai, China
        • Site 8822
      • Shanghai, China
        • Site 8831
      • Xi'an, China
        • Site No. 8823
      • Xi'an, China
        • Site No. 8825
  • France
      • Bondy, France
        • Site No. 9013
      • Bordeaux, France
        • Site No. 9005
      • Créteil, France
        • Site No. 9003
      • Lille, France
        • Site No. 9006
      • Montpellier, France
        • Site 9012
      • Nantes, France
        • Site No. 9008
      • Nice, France
        • Site No. 9010
      • Paris, France
        • Site No. 9007
      • Paris, France
        • Site No. 9014
      • Rennes, France
        • Site No. 9011
      • Strasbourg, France
        • Site No. 9001
      • Toulouse, France
        • Site No. 9002
      • Vandœuvre-lès-Nancy, France
        • Site No. 9009
  • Germany
      • Aachen, Germany
        • Site No. 9111
      • Bonn, Germany
        • Site No. 9113
      • Dresden, Germany
        • Site No. 9109
      • Frankfurt am Main, Germany
        • Site No. 9108
      • Hamburg, Germany
        • Site No. 9106
      • Hannöver, Germany
        • Site No 9105
      • Heidelberg, Germany
        • Site No. 9112
      • Mainz, Germany
        • Site No. 9101
      • München, Germany
        • Site No. 9102
      • Tübingen, Germany
        • Site No. 9104
      • Ulm, Germany
        • Site No. 9110
  • Hong Kong
      • Hong Kong, Hong Kong
        • Site No. 8601
  • Israel
      • Afula, Israel
        • Site No. 9707
      • Haifa, Israel
        • Site 9704
      • Haifa, Israel
        • Site No. 9702
      • Jerusalem, Israel
        • Site No. 9705
      • Ramat-Gan, Israel
        • Site No. 9703
      • Tel Aviv, Israel
        • Site No. 9706
  • Italy
      • Modena, Italy
        • Site No.9205
      • Napoli, Italy
        • Site No. 9204
      • Palermo, Italy
        • Site No. 9201
      • Parma, Italy
        • Site No. 9203
  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Site No. 8208
      • Bucheon, Korea, Republic of
        • Site No. 8211
      • Busan, Korea, Republic of
        • Site No. 8201
      • Daegu, Korea, Republic of
        • Site 8216
      • Daegu, Korea, Republic of
        • Site No. 8207
      • Daegu, Korea, Republic of
        • Site No. 8213
      • Daegu, Korea, Republic of
        • Site No. 8220
      • Goyang, Korea, Republic of
        • Site 8224
      • Jinju-si, Korea, Republic of
        • Site No. 8221
      • Pusan, Korea, Republic of
        • Site No. 8218
      • Seongnam, Korea, Republic of
        • Site No. 8222
      • Seongnam-si, Korea, Republic of
        • Site No. 8219
      • Seoul, Korea, Republic of
        • Site No. 8202
      • Seoul, Korea, Republic of
        • Site No. 8203
      • Seoul, Korea, Republic of
        • Site No. 8205
      • Seoul, Korea, Republic of
        • Site No. 8209
      • Seoul, Korea, Republic of
        • Site No. 8212
      • Seoul, Korea, Republic of
        • Site No. 8215
      • Seoul, Korea, Republic of
        • Site No. 8223
      • Suwon, Korea, Republic of
        • Site No. 8210
      • Ulsan, Korea, Republic of
        • Site No. 8217
  • New Zealand
      • Auckland, New Zealand, 1142
        • Auckland City Hospital
      • Christchurch, New Zealand
        • Site No. 8902
  • Portugal
      • Coimbra, Portugal
        • Site No. 9404
      • Coimbra, Portugal
        • Site No. 9405
      • Lisboa, Portugal
        • Site No. 9403
      • Porto, Portugal
        • Site No. 9401
      • Porto, Portugal
        • Site No. 9402
  • Singapore
      • Singapore, Singapore
        • Site 8702
      • Singapore, Singapore
        • Site 8703
      • Singapore, Singapore
        • Site No. 8701
  • Taiwan
      • Kaohsiung, Taiwan
        • Site No. 8305
      • Linkou, Taiwan
        • Site No. 8307
      • Taichung, Taiwan
        • Site No. 8306
      • Tainan City, Taiwan
        • Site No. 8302
      • Taipei, Taiwan
        • Site No. 8301
      • Taipei, Taiwan
        • Site No. 8303
  • Thailand
      • Bangkok, Thailand
        • Site No. 8502
      • Bangkok, Thailand
        • Site No. 8505
      • Chiang Mai, Thailand
        • Site No. 8503
      • Hat Yai, Thailand
        • Site No. 8507
      • Khon Kaen, Thailand
        • Site No. 8501
      • Phitsanulok, Thailand
        • Site No. 8506
  • United Kingdom
      • Birmingham, United Kingdom
        • Site No. 9501
      • Guildford, United Kingdom
        • Site No. 9505
      • Leeds, United Kingdom
        • Site No. 9503
      • London, United Kingdom
        • Site No. 9502
      • London, United Kingdom
        • Site No. 9504
      • London, United Kingdom
        • Site No. 9506
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • California
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Shands Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center, Inc.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute at Virginia Mason Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Nexavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: From date of randomization to the date of first documented radiographic tumor progression up to 53 months
Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
From date of randomization to the date of first documented radiographic tumor progression up to 53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SillaJen, Inc.

Investigators

  • Study Director: SillaJen Medical, SillaJen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JX594-HEP024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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