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



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:October 2015
End Date:December 2020
Contact:Angelica Craighead
Email:patient_inquiry@sillajen.com
Phone:(415) 814-9865

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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.

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
We found this trial at
24
sites
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Benjamin Tan, M.D.
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Manish Sharma
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Edward Greeno, MD
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: William Stavropoulos, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Timothy Murphy, MD
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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Adelaide, 75056
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Adelaide,
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: Paul Thuluvath, MD
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, MD
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Principal Investigator: Michael Kidd, MD
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Billings, MT
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Birmingham, Alabama 35294
Principal Investigator: Sudha Kodali, MD
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Birmingham, AL
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Anne Noonan, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Muhammad Beg, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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Gainesville, Florida 32608
Principal Investigator: Roniel Cabrera, MD
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Gainesville, FL
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Kansas City, Kansas 66160
Principal Investigator: Raed Al-Rajabi, MD
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Kansas City, KS
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425 Volker Boulevard
Kansas City, Missouri 64131
Principal Investigator: Bradley Freilich, MD
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Kansas City, MO
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Knoxville, Tennessee 37920
Principal Investigator: Laura K Findeiss, MD
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Knoxville, TN
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Robert Martin, MD
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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Morristown, New Jersey 07962
Principal Investigator: Lawrence Harrison, MD
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Morristown, NJ
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Principal Investigator: Fredric Regenstein, MD
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New Orleans, LA
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Orange, California 92868
Principal Investigator: Nadine Abi-Jaoudeh, MD
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Orange, CA
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Palo Alto, California 94304
Principal Investigator: Nishita Kothary, MD
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Palo Alto, CA
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Paterson, New Jersey 07503
Principal Investigator: Howard Benn, MD
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Paterson, NJ
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Saint Louis, Missouri 63110
Principal Investigator: Alex Befeler, MD
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Saint Louis, MO
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Mitesh Borad, MD
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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Seattle, Washington 98101
Principal Investigator: Shih-Li Lin, MD
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Seattle, WA
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