A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer (FLASH)

Jennerex Biotherapeutics

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carinoma

Treatments

Biological: JX-594 recombinant vaccina GM-CSF

Study type

Interventional

Funder types

Industry

Identifiers

NCT01636284

JX594-IV-HEP021

Details and patient eligibility

About

This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.

Full description

This was a Phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced HCC.

Patients received 5 weekly IV infusions of Pexa-Vec and could have continued to receive IV infusions of Pexa-Vec every 3 weeks until progressive disease (PD).

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

KEY Inclusion Criteria:

Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (HCC)
Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
ECOG performance status 0, 1 or 2
Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
Platelet count ≥50,000 plts/mm3
WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3
Hemoglobin ≥10 g/dL
Adequate liver function

KEY Exclusion Criteria:

Received sorafenib as previous treatment for HCC for more than 14 days
History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for > 4 weeks)
Prior treatment with JX-594
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
Significant bleeding event within the last 12 months.