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

NCT ID: NCT02562755

Last Updated: 2020-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma (HCC)

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pexastimogene Devacirepvec (Pexa Vec)

Intervention Type BIOLOGICAL

Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.

Sorafenib

Intervention Type DRUG

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.

Sorafenib

Sorafenib (400 mg twice daily) begins on Day 1.

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Other Intervention Names

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JX-594 Nexavar

Eligibility Criteria

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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:

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SillaJen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SillaJen Medical

Role: STUDY_DIRECTOR

SillaJen, Inc.

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

UC Irvine Medical Center

Orange, California, United States

Site Status

Stanford University School of Medicine

Palo Alto, California, United States

Site Status

University of Florida Shands Hospital

Gainesville, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Mercy Medical Center, Inc.

Baltimore, Maryland, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Kansas City Research Institute

Kansas City, Missouri, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Billings Clinic

Billings, Montana, United States

Site Status

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

St. Joseph's Hospital

Paterson, New Jersey, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Hospital of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Benaroya Research Institute at Virginia Mason Hospital

Seattle, Washington, United States

Site Status

Site No. 8409

Adelaide, , Australia

Site Status

Site No. 8412

Adelaide, , Australia

Site Status

Site No. 8403

Brisbane, , Australia

Site Status

Site No. 8401

Camperdown, , Australia

Site Status

Site No. 8407

Clayton, , Australia

Site Status

Site No. 8406

Concord, , Australia

Site Status

Site No. 8408

Fitzroy, , Australia

Site Status

Site No. 8405

Footscray, , Australia

Site Status

Site No. 8414

Heidelberg, , Australia

Site Status

Site No. 8411

Melbourne, , Australia

Site Status

Site No. 8402

Parkville, , Australia

Site Status

Site No. 8415

Perth, , Australia

Site Status

Site No. 8413

Sydney, , Australia

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Site 8829

Changchun, , China

Site Status

Site No. 8821

Changsha, , China

Site Status

Site 8811

Fuzhou, , China

Site Status

Site 8820

Fuzhou, , China

Site Status

Site No.8816

Guangdong, , China

Site Status

Site 8827

Guangzhou, , China

Site Status

Site No.8828

Guangzhou, , China

Site Status

Site 8832

Hangzhou, , China

Site Status

Site No. 8802

Harbin, , China

Site Status

Site 8805

Hefei, , China

Site Status

Site No. 8808

Hefei, , China

Site Status

Site No.8815

Hefei, , China

Site Status

Site No. 8801

Nanjing, , China

Site Status

Site 8833

Qingdao, , China

Site Status

Site 8806

Shanghai, , China

Site Status

Site 8822

Shanghai, , China

Site Status

Site 8831

Shanghai, , China

Site Status

Site No. 8823

Xi'an, , China

Site Status

Site No. 8825

Xi'an, , China

Site Status

Site No. 9013

Bondy, , France

Site Status

Site No. 9005

Bordeaux, , France

Site Status

Site No. 9003

Créteil, , France

Site Status

Site No. 9006

Lille, , France

Site Status

Site 9012

Montpellier, , France

Site Status

Site No. 9008

Nantes, , France

Site Status

Site No. 9010

Nice, , France

Site Status

Site No. 9007

Paris, , France

Site Status

Site No. 9014

Paris, , France

Site Status

Site No. 9011

Rennes, , France

Site Status

Site No. 9001

Strasbourg, , France

Site Status

Site No. 9002

Toulouse, , France

Site Status

Site No. 9009

Vandœuvre-lès-Nancy, , France

Site Status

Site No. 9111

Aachen, , Germany

Site Status

Site No. 9113

Bonn, , Germany

Site Status

Site No. 9109

Dresden, , Germany

Site Status

Site No. 9108

Frankfurt am Main, , Germany

Site Status

Site No. 9106

Hamburg, , Germany

Site Status

Site No 9105

Hannover, , Germany

Site Status

Site No. 9112

Heidelberg, , Germany

Site Status

Site No. 9101

Mainz, , Germany

Site Status

Site No. 9102

München, , Germany

Site Status

Site No. 9104

Tübingen, , Germany

Site Status

Site No. 9110

Ulm, , Germany

Site Status

Site No. 8601

Hong Kong, , Hong Kong

Site Status

Site No. 9707

Afula, , Israel

Site Status

Site 9704

Haifa, , Israel

Site Status

Site No. 9702

Haifa, , Israel

Site Status

Site No. 9705

Jerusalem, , Israel

Site Status

Site No. 9703

Ramat Gan, , Israel

Site Status

Site No. 9706

Tel Aviv, , Israel

Site Status

Site No.9205

Modena, , Italy

Site Status

Site No. 9204

Napoli, , Italy

Site Status

Site No. 9201

Palermo, , Italy

Site Status

Site No. 9203

Parma, , Italy

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Site No. 8902

Christchurch, , New Zealand

Site Status

Site No. 9404

Coimbra, , Portugal

Site Status

Site No. 9405

Coimbra, , Portugal

Site Status

Site No. 9403

Lisbon, , Portugal

Site Status

Site No. 9401

Porto, , Portugal

Site Status

Site No. 9402

Porto, , Portugal

Site Status

Site 8702

Singapore, , Singapore

Site Status

Site 8703

Singapore, , Singapore

Site Status

Site No. 8701

Singapore, , Singapore

Site Status

Site No. 8208

Ansan, , South Korea

Site Status

Site No. 8211

Bucheon-si, , South Korea

Site Status

Site No. 8201

Busan, , South Korea

Site Status

Site 8216

Daegu, , South Korea

Site Status

Site No. 8207

Daegu, , South Korea

Site Status

Site No. 8213

Daegu, , South Korea

Site Status

Site No. 8220

Daegu, , South Korea

Site Status

Site 8224

Goyang, , South Korea

Site Status

Site No. 8221

Jinju, , South Korea

Site Status

Site No. 8218

Pusan, , South Korea

Site Status

Site No. 8222

Seongnam, , South Korea

Site Status

Site No. 8219

Seongnam-si, , South Korea

Site Status

Site No. 8202

Seoul, , South Korea

Site Status

Site No. 8203

Seoul, , South Korea

Site Status

Site No. 8205

Seoul, , South Korea

Site Status

Site No. 8209

Seoul, , South Korea

Site Status

Site No. 8212

Seoul, , South Korea

Site Status

Site No. 8215

Seoul, , South Korea

Site Status

Site No. 8223

Seoul, , South Korea

Site Status

Site No. 8210

Suwon, , South Korea

Site Status

Site No. 8217

Ulsan, , South Korea

Site Status

Site No. 8305

Kaohsiung City, , Taiwan

Site Status

Site No. 8307

Linkou District, , Taiwan

Site Status

Site No. 8306

Taichung, , Taiwan

Site Status

Site No. 8302

Tainan City, , Taiwan

Site Status

Site No. 8301

Taipei, , Taiwan

Site Status

Site No. 8303

Taipei, , Taiwan

Site Status

Site No. 8502

Bangkok, , Thailand

Site Status

Site No. 8505

Bangkok, , Thailand

Site Status

Site No. 8503

Chiang Mai, , Thailand

Site Status

Site No. 8507

Hat Yai, , Thailand

Site Status

Site No. 8501

Khon Kaen, , Thailand

Site Status

Site No. 8506

Phitsanulok, , Thailand

Site Status

Site No. 9501

Birmingham, , United Kingdom

Site Status

Site No. 9505

Guildford, , United Kingdom

Site Status

Site No. 9503

Leeds, , United Kingdom

Site Status

Site No. 9502

London, , United Kingdom

Site Status

Site No. 9504

London, , United Kingdom

Site Status

Site No. 9506

London, , United Kingdom

Site Status

Countries

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United States Australia Canada China France Germany Hong Kong Israel Italy New Zealand Portugal Singapore South Korea Taiwan Thailand United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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JX594-HEP024

Identifier Type: -

Identifier Source: org_study_id