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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01387555
First received: June 27, 2011
Last updated: January 13, 2014
Last verified: July 2012
  Purpose

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
HCC
Biological: JX-594 recombinant vaccina GM-CSF
Other: Best Supportive Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    Determine time to progression of Arm A compared to Arm B.


Enrollment: 129
Study Start Date: August 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387555

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

Additional Information:
No publications provided

Responsible Party: Jennerex Biotherapeutics
ClinicalTrials.gov Identifier: NCT01387555     History of Changes
Other Study ID Numbers: JX594-HEP018
Study First Received: June 27, 2011
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Jennerex Biotherapeutics:
liver cancer
liver tumor
advanced hcc
hepatocellular cancer
Jennerex
HCC
Advanced HCC
sorafenib
sorafenib failure
sorafenib intolerant
Nexavar
Nexavar failure
JX594
oncolytic virus
vaccinia
viral therapy
JX
Biotherapeutics
HEP018
traverse
biologic
Pexa-Vec

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Vaccinia
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Adenocarcinoma
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014