Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
PHOCUS
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
1 other identifier
interventional
459
16 countries
142
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2015
Longer than P75 for phase_3
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedResults Posted
Study results publicly available
December 16, 2020
CompletedDecember 16, 2020
December 1, 2020
4.8 years
September 24, 2015
September 22, 2020
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
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
Study Arms (2)
Pexa-Vec followed by Sorafenib
EXPERIMENTALPexa-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.
Sorafenib
ACTIVE COMPARATORSorafenib (400 mg twice daily) begins on Day 1.
Interventions
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
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.
Eligibility Criteria
You may qualify if:
- 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:
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SillaJen, Inc.lead
Study Sites (142)
University of Alabama
Birmingham, Alabama, 35294, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
UC Irvine Medical Center
Orange, California, 92868, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
University of Florida Shands Hospital
Gainesville, Florida, 32608, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66205, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Mercy Medical Center, Inc.
Baltimore, Maryland, 21202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic
Billings, Montana, 59101, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
St. Joseph's Hospital
Paterson, New Jersey, 07503, United States
Ohio State University
Columbus, Ohio, 43210, United States
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Benaroya Research Institute at Virginia Mason Hospital
Seattle, Washington, 98101, United States
Site No. 8409
Adelaide, Australia
Site No. 8412
Adelaide, Australia
Site No. 8403
Brisbane, Australia
Site No. 8401
Camperdown, Australia
Site No. 8407
Clayton, Australia
Site No. 8406
Concord, Australia
Site No. 8408
Fitzroy, Australia
Site No. 8405
Footscray, Australia
Site No. 8414
Heidelberg, Australia
Site No. 8411
Melbourne, Australia
Site No. 8402
Parkville, Australia
Site No. 8415
Perth, Australia
Site No. 8413
Sydney, Australia
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 1C3, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Site 8829
Changchun, China
Site No. 8821
Changsha, China
Site 8811
Fuzhou, China
Site 8820
Fuzhou, China
Site No.8816
Guangdong, China
Site 8827
Guangzhou, China
Site No.8828
Guangzhou, China
Site 8832
Hangzhou, China
Site No. 8802
Harbin, China
Site 8805
Hefei, China
Site No. 8808
Hefei, China
Site No.8815
Hefei, China
Site No. 8801
Nanjing, China
Site 8833
Qingdao, China
Site 8806
Shanghai, China
Site 8822
Shanghai, China
Site 8831
Shanghai, China
Site No. 8823
Xi'an, China
Site No. 8825
Xi'an, China
Site No. 9013
Bondy, France
Site No. 9005
Bordeaux, France
Site No. 9003
Créteil, France
Site No. 9006
Lille, France
Site 9012
Montpellier, France
Site No. 9008
Nantes, France
Site No. 9010
Nice, France
Site No. 9007
Paris, France
Site No. 9014
Paris, France
Site No. 9011
Rennes, France
Site No. 9001
Strasbourg, France
Site No. 9002
Toulouse, France
Site No. 9009
VandÅ“uvre-lès-Nancy, France
Site No. 9111
Aachen, Germany
Site No. 9113
Bonn, Germany
Site No. 9109
Dresden, Germany
Site No. 9108
Frankfurt am Main, Germany
Site No. 9106
Hamburg, Germany
Site No 9105
Hannover, Germany
Site No. 9112
Heidelberg, Germany
Site No. 9101
Mainz, Germany
Site No. 9102
MĂ¼nchen, Germany
Site No. 9104
TĂ¼bingen, Germany
Site No. 9110
Ulm, Germany
Site No. 8601
Hong Kong, Hong Kong
Site No. 9707
Afula, Israel
Site 9704
Haifa, Israel
Site No. 9702
Haifa, Israel
Site No. 9705
Jerusalem, Israel
Site No. 9703
Ramat Gan, Israel
Site No. 9706
Tel Aviv, Israel
Site No.9205
Modena, Italy
Site No. 9204
Napoli, Italy
Site No. 9201
Palermo, Italy
Site No. 9203
Parma, Italy
Auckland City Hospital
Auckland, 1142, New Zealand
Site No. 8902
Christchurch, New Zealand
Site No. 9404
Coimbra, Portugal
Site No. 9405
Coimbra, Portugal
Site No. 9403
Lisbon, Portugal
Site No. 9401
Porto, Portugal
Site No. 9402
Porto, Portugal
Site 8702
Singapore, Singapore
Site 8703
Singapore, Singapore
Site No. 8701
Singapore, Singapore
Site No. 8208
Ansan, South Korea
Site No. 8211
Bucheon-si, South Korea
Site No. 8201
Busan, South Korea
Site 8216
Daegu, South Korea
Site No. 8207
Daegu, South Korea
Site No. 8213
Daegu, South Korea
Site No. 8220
Daegu, South Korea
Site 8224
Goyang, South Korea
Site No. 8221
Jinju, South Korea
Site No. 8218
Pusan, South Korea
Site No. 8222
Seongnam, South Korea
Site No. 8219
Seongnam-si, South Korea
Site No. 8202
Seoul, South Korea
Site No. 8203
Seoul, South Korea
Site No. 8205
Seoul, South Korea
Site No. 8209
Seoul, South Korea
Site No. 8212
Seoul, South Korea
Site No. 8215
Seoul, South Korea
Site No. 8223
Seoul, South Korea
Site No. 8210
Suwon, South Korea
Site No. 8217
Ulsan, South Korea
Site No. 8305
Kaohsiung City, Taiwan
Site No. 8307
Linkou District, Taiwan
Site No. 8306
Taichung, Taiwan
Site No. 8302
Tainan, Taiwan
Site No. 8301
Taipei, Taiwan
Site No. 8303
Taipei, Taiwan
Site No. 8502
Bangkok, Thailand
Site No. 8505
Bangkok, Thailand
Site No. 8503
Chiang Mai, Thailand
Site No. 8507
Hat Yai, Thailand
Site No. 8501
Khon Kaen, Thailand
Site No. 8506
Phitsanulok, Thailand
Site No. 9501
Birmingham, United Kingdom
Site No. 9505
Guildford, United Kingdom
Site No. 9503
Leeds, United Kingdom
Site No. 9502
London, United Kingdom
Site No. 9504
London, United Kingdom
Site No. 9506
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kyoung Soo Ha, Senior Medical Director
- Organization
- SillaJen Biotherapeutics Inc.
Study Officials
- STUDY DIRECTOR
SillaJen Medical
SillaJen, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2015
First Posted
September 29, 2015
Study Start
October 1, 2015
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
December 16, 2020
Results First Posted
December 16, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share