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

NCT01387555 | Completed Phase 2 DMC

• 1 other identifier: JX594-HEP018
• Study Type: interventional
• Target: 129
• Locations: 7 countries
• Sites: 38

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.

Conditions

Hepatocellular Carcinoma; Liver Cancer; HCC

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  CT scan every six weeks until progression or death, assessed up to 21 months

Secondary Outcomes (5)

• Time to Tumor Progression

  CT scan every six weeks until progression or death, assessed up to 21 months

• Quality of Life

  assessed up to 21 months (average)

• Tumor Response

  CT scan every 6 weeks until progression or death, assessed up to 21 months (average)

• Safety profile of JX594

  assessed up to 21 months (average)

• Time-to-symptomatic-progression

  assessed up to 21 months (average)

Study Arms (2)

Arm A

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.

Biological: JX-594 recombinant vaccina GM-CSF

Arm B

OTHER

Patients on the control arm (Arm B) will have best supportive care over 18 weeks.

Other: Best Supportive Care

Interventions

JX-594 recombinant vaccina GM-CSF BIOLOGICAL

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 A

Best Supportive Care OTHER

Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jennerex Biotherapeutics: lead

Study Sites (38)

Moores University of California San Diego Cancer Center

La Jolla, California, 92093, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

California Pacific Medical Center

San Francisco, California, United States

Location

Stanford Hospital and Clinics

Stanford, California, United States

Location

University of Chicago Medical Center

Chicago, Illinois, United States

Location

Billings Clinic

Billings, Montana, United States

Location

Saint Joseph's Hospital

Paterson, New Jersey, United States

Location

Montefiore Medical Center

The Bronx, New York, United States

Location

Gabrail Cancer Center

Canton, Ohio, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Location

The Methodist Hospital Department of Surgery

Houston, Texas, 77030, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

Ottawa Hopsital Research Institute

Ottawa, Ontario, Canada

Location

Hôpitaux Universitaires de Strasbourg - Hôpital Civil

Strasbourg, Alsace, 67091, France

Location

Centre Hospitalier Universitaire Hôpital Saint André

Bordeaux, Aquitaine, 33000, France

Location

Hôpital de la Croix Rousse

Lyon, Auvergne-Rhône-Alpes, 69317, France

Location

CHU d'Estaing

Clermont-Ferrand, Auvergne, 63003, France

Location

Hôpital Purpan

Toulouse, Midi-Pyrenees, 31059, France

Location

Hôpital Saint Antoine, CPP Ile de France V

Paris, Île-de-France Region, 75571, France

Location

Klinikum Rechts der Isar der Technischen Universität München

München, Bavaria, 81675, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 425-707, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital,Yonsei University Health System

Seoul, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

National Cheng-Kung University Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31413923 DERIVED

Related Links

• Sponsor Website

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Vaccinia; Oculocerebral hypopigmentation syndrome type Preus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; 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; Infections

Study Officials

• James Burke, MD

  Jennerex Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 4, 2011
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (11); CA (4); FR (6); HK (1); KR (9); TW (3); DE (4)