Phase 2
N=16
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer
Hepatocellular Carinoma
Bottom Line
View on ClinicalTrials.gov: NCT01636284 ↗Enrolled (actual)
16
Serious AEs
50.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Radiographic Response — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JX-594 recombinant vaccina GM-CSF (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jennerex Biotherapeutics
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Radiographic Response |
4 | — |
| SECONDARY Time to Progression (TTP) |
1.38 | — |
| SECONDARY Overall Survival (OS) |
7.47 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01636284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.