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A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib (TRAVERSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01387555
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Jennerex Biotherapeutics

Brief Summary:
This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Cancer HCC Biological: JX-594 recombinant vaccina GM-CSF Other: Best Supportive Care Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment
Study Start Date : December 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: Arm A
Patients on Arm A will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Biological: JX-594 recombinant vaccina GM-CSF
Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.

Arm B
Patients on the control arm (Arm B) will have best supportive care over 18 weeks.
Other: Best Supportive Care
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.

Primary Outcome Measures :
  1. Survival [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ]
    Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.

Secondary Outcome Measures :
  1. Time to Tumor Progression [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ]
    Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.

  2. Quality of Life [ Time Frame: assessed up to 21 months (average) ]
    Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.

  3. Tumor Response [ Time Frame: CT scan every 6 weeks until progression or death, assessed up to 21 months (average) ]
    Determine tumor response based on mRECIST for HCC of Arm A versus Arm B

  4. Safety profile of JX594 [ Time Frame: assessed up to 21 months (average) ]
    Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)

  5. Time-to-symptomatic-progression [ Time Frame: assessed up to 21 months (average) ]
    Determine time to progression of Arm A compared to Arm B.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

KEY Inclusion Criteria:

  • Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis
  • Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC
  • ECOG performance status 0, 1 or 2
  • Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
  • Hematocrit ≥30% or Hemoglobin ≥10 g/dL
  • Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited >25% growth in viable tumor size since prior local-regional treatment.

KEY Exclusion Criteria:

  • Received sorafenib within 14 days prior to randomization
  • Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization
  • Prior treatment with JX-594
  • Platelet count < 50,000 PLT/ mm3
  • Total white blood cell count < 2,000 cells/mm3
  • Prior or planned organ transplant
  • Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
  • Severe or unstable cardiac disease
  • Viable CNS malignancy associated with clinical symptoms
  • Pregnant or nursing an infant
  • History of inflammatory skin condition (e.g., eczema requiring previous treatment, atopic dermatitis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01387555

  Hide Study Locations
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United States, California
Moores University of California San Diego Cancer Center
La Jolla, California, United States, 92093
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
California Pacific Medical Center
San Francisco, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States
United States, Montana
Billings Clinic
Billings, Montana, United States
United States, New Jersey
Saint Joseph's Hospital
Paterson, New Jersey, United States
United States, New York
Montefiore Medical Center
Bronx, New York, United States
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
United States, Texas
The Methodist Hospital Department of Surgery
Houston, Texas, United States, 77030
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Ottawa Hopsital Research Institute
Ottawa, Ontario, Canada
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg Cedex, Alsace, France, 67091
Centre Hospitalier Universitaire Hôpital Saint André
Bordeaux, Aquitaine, France, 33000
CHU d'Estaing
Clermont-Ferrand, Auvergne, France, 63003
Hôpital Saint Antoine, CPP Ile de France V
Paris, Ile-de-France, France, 75571
Hôpital Purpan
Toulouse, Midi-Pyrenees, France, 31059
Hôpital de la Croix Rousse
Lyon Cedex, Rhone-Alpes, France, 69317
Klinikum Rechts der Isar der Technischen Universität München
München, Bayern, Germany, 81675
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Johannes Gutenberg-Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Korea, Republic of
Korea University Ansan Hospital
Ansan-si, Gyeonggi-Do, Korea, Republic of, 425-707
Kyungpook National University Hospital
Daegu, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Guro Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Severance Hospital,Yonsei University Health System
Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of
National Cheng-Kung University Hospital
TPE, Taiwan
National Taiwan University Hospital
TPE, Taiwan
Taipei Veterans General Hospital
TPE, Taiwan
Sponsors and Collaborators
Jennerex Biotherapeutics
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Study Director: James Burke, MD Jennerex Biotherapeutics

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jennerex Biotherapeutics Identifier: NCT01387555     History of Changes
Other Study ID Numbers: JX594-HEP018
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Jennerex Biotherapeutics:
liver cancer
liver tumor
advanced hcc
hepatocellular cancer
sorafenib failure
sorafenib intolerant
Nexavar failure
oncolytic virus
viral therapy
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs