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

Jennerex Biotherapeutics

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma; HCC; Liver Cancer

Treatments: Biological: JX-594 recombinant vaccina GM-CSF; Other: Best Supportive Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01387555

JX594-HEP018

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

Biological: JX-594 recombinant vaccina GM-CSF

Arm B

Other group

Description:

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

Treatment:

Other: Best Supportive Care