Hepatocellular CarcinomaPhase 2TRAVERSENCT01387555
A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
A Phase 2 study testing JX-594 recombinant vaccina GM-CSF in people with Hepatocellular Carcinoma and Liver Cancer, run by Jennerex Biotherapeutics at 38 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer, HCC
- What is being tested?
- JX-594 recombinant vaccina GM-CSF
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 38 sitesin 7 countries
- Study dates
- 8 Oct 2011to 1 Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
United States11 sites
Billings Clinic
Billings, Montana
Gabrail Cancer Center
Canton, Ohio
University of Chicago Medical Center
Chicago, Illinois
University Hospitals Case Medical Center
Cleveland, Ohio
The Methodist Hospital Department of Surgery
Houston, Texas, 77030
Moores University of California San Diego Cancer Center
La Jolla, California, 92093
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Saint Joseph's Hospital
Paterson, New Jersey
California Pacific Medical Center
San Francisco, California
Stanford Hospital and Clinics
Stanford, California
Montefiore Medical Center
The Bronx, New York
South Korea9 sites
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 425-707
Kyungpook National University Hospital
Daegu
Pusan National University Hospital
Pusan
Asan Medical Center
Seoul, 138-736
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital,Yonsei University Health System
Seoul
Pusan National University Yangsan Hospital
Yangsan
France6 sites
Centre Hospitalier Universitaire Hôpital Saint André
Bordeaux, Aquitaine, 33000
CHU d'Estaing
Clermont-Ferrand, Auvergne, 63003
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, 69317
Hôpital Saint Antoine, CPP Ile de France V
Paris, Île-de-France Region, 75571
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg, Alsace, 67091
Hôpital Purpan
Toulouse, Midi-Pyrenees, 31059
Canada4 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
Juravinski Cancer Centre
Hamilton, Ontario
Ottawa Hopsital Research Institute
Ottawa, Ontario
University of British Columbia
Vancouver, British Columbia
Germany4 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, 55131
Klinikum Rechts der Isar der Technischen Universität München
München, Bavaria, 81675
Taiwan3 sites
National Cheng-Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
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
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.
Read the detailed description
This Phase 2b, open-label, randomized, multi-center study is designed to evaluate the efficacy and safety of JX-594 (Pexa-Vec) in patients with advanced hepatocellular carcinoma (HCC) who have previously failed sorafenib treatment. Eligible patients are randomly assigned in a 2:1 ratio to receive either the experimental therapy (JX-594 plus Best Supportive Care [BSC]) or the control therapy (BSC alone).
Patients assigned to the experimental arm receive an initial intravenous (IV) infusion of JX-594 on Day 1. This is followed by intratumoral (IT) injections of JX-594 directly into viable liver tumors under imaging guidance on Day 8, Day 22, and Weeks 6, 12, and 18. These patients will also receive BSC, but active anti-cancer treatments are strictly prohibited. In contrast, patients in the control arm receive only Best Supportive Care (e.g., hydration, nutrition, pain management) at the treating physician's discretion without any study drug injections. Experimental or active anti-cancer therapies are not permitted in the control arm.
The primary objective of this study is to compare the Overall Survival (OS) between the two treatment arms. Secondary objectives include evaluating Time-to-Tumor Progression (TTP) and objective response rate based on mRECIST criteria for HCC. The study also evaluates Time-to-Symptomatic Progression (TSP), which is defined by changes in the FACT Hepatobiliary Symptom Index (FHSI-8) questionnaire and ECOG performance status. Additionally, the study assesses changes in Quality of Life (QoL) measured by EORTC and FACT-Hep questionnaires. Finally, overall safety and tolerability are closely monitored through the incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) graded according to NCI CTCAE v4.03, along with clinical laboratory evaluations.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, HCC
- Being tested
- JX-594 recombinant vaccina GM-CSF, Best Supportive Care
- Keywords
- liver cancer, liver tumor, hepatocellular cancer, Jennerex, HCC, Advanced HCC, sorafenib, sorafenib failure, sorafenib intolerant, Nexavar, Nexavar failure, JX594, oncolytic virus, viral therapy, JX, Biotherapeutics, vaccinia, HEP018, traverse, biologic
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Vaccinia, Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JX-594 recombinant vaccina GM-CSFBiological
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.
Best Supportive CareOther
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
| Study group | Role | What they receive |
|---|---|---|
| JX-594 + Best Supportive Care | Experimental | 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. Receives: Biological: JX-594 recombinant vaccina GM-CSF |
| Best Supportive Care | Other | Patients on the control arm (Arm B) will have best supportive care over 18 weeks. Receives: Other: Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
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.
Measured: From randomization until death from any cause, assessed up to 21 months.
Secondary outcomes (5)
Time to Tumor Progression
Determine time-to-tumor-progression (TTP) for JX-594 + BSC compared with BSC alone based on mRECIST for HCC. Progression is defined as 2 consecutive time points with increases in the sum of the longest diameters (SLD) of viable target tumors of at least 20% for each time point.
Measured: CT scan every six weeks until progression or death, assessed up to 21 months
Mean Percent Change From Baseline in Quality of Life (FACT-Hep Score)
Change in Quality of Life (QoL) over time based on the physical well-being and additional concerns domains of the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Questionnaire. The FACT-Hep measures health-related quality of life in patients with hepatobiliary cancer. The item scores from these specific subscales are summed to compute a combined score. The combined score ranges from 0 to 100. Higher scores represent a better quality of life and a better outcome.
Measured: Baseline to Visit 8 (Week 6 ) and Visit 11 (Week 12)
Overall Disease Control Rate (Tumor Response)
The overall disease control rate is defined as the percentage of patients achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) for Hepatocellular Carcinoma (HCC). Per mRECIST for HCC, CR is the disappearance of any intratumoral arterial enhancement in all target lesions; PR is a >=30% decrease in the sum of the longest diameters (SLD) of viable target lesions; and SD is disease that does not qualify for either PR or progressive disease. Best response over all time points after Baseline was used.
Measured: CT scan every 6 weeks until progression or death, assessed up to 21 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 28 days after the last dose of study drug, assessed up to 14 months.
Time-to-symptomatic-progression
Symptomatic progression is defined as a decrease of 4 points or more from Baseline in the FHSI-8 questionnaire (that was confirmed 3 weeks later), or a decrease in ECOG performance status to 4, or death.
Measured: From randomization until symptomatic progression or death, assessed up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study start8 Oct 2011
- Primary completion1 Oct 2013
- Study completion1 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennerex Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Burke, MD, Study director, Jennerex Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387555
- Sponsor's protocol ID
- JX594-HEP018
- Acronym
- TRAVERSE
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2011
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Moehler M, Heo J, Lee HC, Tak WY, Chao Y, Paik SW, Yim HJ, Byun KS, Baron A, Ungerechts G, Jonker D, Ruo L, Cho M, Kaubisch A, Wege H, Merle P, Ebert O, Habersetzer F, Blanc JF, Rosmorduc O, Lencioni R, Patt R, Leen AM, Foerster F, Homerin M, Stojkowitz N, Lusky M, Limacher JM, Hennequi M, Gaspar N, McFadden B, De Silva N, Shen D, Pelusio A, Kirn DH, Breitbach CJ, Burke JM. Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE). Oncoimmunology. 2019 Jun 3;8(8):1615817. doi: 10.1080/2162402X.2019.1615817. eCollection 2019.
PubMed 31413923
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01387555
- Acronym / sponsor ID
- TRAVERSE / JX594-HEP018
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, HCC
- Keywords
- liver cancer, liver tumor, hepatocellular cancer, Jennerex, HCC, Advanced HCC, sorafenib, sorafenib failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Jennerex BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2011 (actual)
- Primary completion
- 1 Oct 2013 (actual)
- Study completion
- 1 Oct 2013 (actual)
- First posted
- 4 Jul 2011 (estimated)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase 2b, open-label, randomized, multi-center study is designed to evaluate the efficacy and safety of JX-594 (Pexa-Vec) in patients with advanced hepatocellular carcinoma (HCC) who have previously failed sorafenib treatment. Eligible patients are randomly assigned in a 2:1 ratio to receive either the experimental therapy (JX-594 plus Best Supportive Care [BSC]) or the control therapy (BSC alone).
Patients assigned to the experimental arm receive an initial intravenous (IV) infusion of JX-594 on Day 1. This is followed by intratumoral (IT) injections of JX-594 directly into viable liver tumors under imaging guidance on Day 8, Day 22, and Weeks 6, 12, and 18. These patients will also receive BSC, but active anti-cancer treatments are strictly prohibited. In contrast, patients in the control arm receive only Best Supportive Care (e.g., hydration, nutrition, pain management) at the treating physician's discretion without any study drug injections. Experimental or active anti-cancer therapies are not permitted in the control arm.
The primary objective of this study is to compare the Overall Survival (OS) between the two treatment arms. Secondary objectives include evaluating Time-to-Tumor Progression (TTP) and objective response rate based on mRECIST criteria for HCC. The study also evaluates Time-to-Symptomatic Progression (TSP), which is defined by changes in the FACT Hepatobiliary Symptom Index (FHSI-8) questionnaire and ECOG performance status. Additionally, the study assesses changes in Quality of Life (QoL) measured by EORTC and FACT-Hep questionnaires. Finally, overall safety and tolerability are closely monitored through the incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) graded according to NCI CTCAE v4.03, along with clinical laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JX-594 + Best Supportive Care | Experimental | Biological: JX-594 recombinant vaccina GM-CSFPatients 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. |
| Best Supportive Care | Other | Other: Best Supportive CarePatients on the control arm (Arm B) will have best supportive care over 18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JX-594 recombinant vaccina GM-CSFPatients 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. | Biological | JX-594 + Best Supportive Care |
| Best Supportive CarePatients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed. | Other | Best Supportive Care |
Primary outcome
Survival
Time frame: From randomization until death from any cause, 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.
5 secondary outcomes
Time to Tumor Progression
Time frame: CT scan every six weeks until progression or death, assessed up to 21 months
Mean Percent Change From Baseline in Quality of Life (FACT-Hep Score)
Time frame: Baseline to Visit 8 (Week 6 ) and Visit 11 (Week 12)
Overall Disease Control Rate (Tumor Response)
Time frame: CT scan every 6 weeks until progression or death, assessed up to 21 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 28 days after the last dose of study drug, assessed up to 14 months.
Time-to-symptomatic-progression
Time frame: From randomization until symptomatic progression or death, assessed up to 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31413923Moehler M, Heo J, Lee HC, Tak WY, Chao Y, Paik SW, Yim HJ, Byun KS, Baron A, Ungerechts G, Jonker D, Ruo L, Cho M, Kaubisch A, Wege H, Merle P, Ebert O, Habersetzer F, Blanc JF, Rosmorduc O, Lencioni R, Patt R, Leen AM, Foerster F, Homerin M, Stojkowitz N, Lusky M, Limacher JM, Hennequi M, Gaspar N, McFadden B, De Silva N, Shen D, Pelusio A, Kirn DH, Breitbach CJ, Burke JM. Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE). Oncoimmunology. 2019 Jun 3;8(8):1615817. doi: 10.1080/2162402X.2019.1615817. eCollection 2019.
- Sponsor WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Burke, MD study director
Jennerex Biotherapeutics
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JX-594 recombinant vaccina GM-CSF in people with Hepatocellular Carcinoma and Liver Cancer, run by Jennerex Biotherapeutics at 38 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, South Korea, France, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: From randomization until death from any cause, assessed up to 21 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01387555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.