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

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ClinicalTrials.gov Identifier: NCT01387555
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE July 4, 2011
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2011)
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 placebo plus best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
Change History Complete list of historical versions of study NCT01387555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2011)
  • 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 verus 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Liver Cancer
  • HCC
Intervention  ICMJE
  • 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: Best Supportive Care
    Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: JX-594 recombinant vaccina GM-CSF
  • Arm B
    Patients on the control arm (Arm B) will have best supportive care over 18 weeks.
    Intervention: Other: Best Supportive Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
129
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2011)
120
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Hong Kong,   Korea, Republic of,   Taiwan,   United States
Removed Location Countries Italy,   Spain
 
Administrative Information
NCT Number  ICMJE NCT01387555
Other Study ID Numbers  ICMJE JX594-HEP018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennerex Biotherapeutics
Study Sponsor  ICMJE Jennerex Biotherapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: James Burke, MD Jennerex Biotherapeutics
PRS Account Jennerex Biotherapeutics
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP