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

This study has been completed.
Information provided by (Responsible Party):
Jennerex Biotherapeutics Identifier:
First received: June 27, 2011
Last updated: March 10, 2015
Last verified: March 2015
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 Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
Biological: JX-594 recombinant vaccina GM-CSF
Other: Best Supportive Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Jennerex Biotherapeutics:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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

  • 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)

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

Enrollment: 129
Study Start Date: December 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01387555

  Show 38 Study Locations
Sponsors and Collaborators
Jennerex Biotherapeutics
Study Director: James Burke, MD Jennerex Biotherapeutics
  More Information

Additional Information:
Responsible Party: Jennerex Biotherapeutics Identifier: NCT01387555     History of Changes
Other Study ID Numbers: JX594-HEP018
Study First Received: June 27, 2011
Last Updated: March 10, 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:
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 processed this record on May 25, 2017