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

March 10, 2015 updated by: Jennerex Biotherapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
CT scan every six weeks until progression or death, assessed up to 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
CT scan every six weeks until progression or death, assessed up to 21 months
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.
assessed up to 21 months (average)
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
CT scan every 6 weeks until progression or death, assessed up to 21 months (average)
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)
assessed up to 21 months (average)
Time-to-symptomatic-progression
Time Frame: assessed up to 21 months (average)
Determine time to progression of Arm A compared to Arm B.
assessed up to 21 months (average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennerex Biotherapeutics

Investigators

  • Study Director: James Burke, MD, Jennerex Biotherapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

July 1, 2011

First Posted (Estimate)

July 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JX594-HEP018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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