HCC
Conditions
Brief summary
This is a randomized, open-label, multi-site Phase II study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report, who were eligible to undergo definitive resection, have demonstrated laboratory, radiographic and/or pathologic high-risk criteria for recurrence (described under eligibility), have no evidence of disease (NED) as per MRI approximately 28 days post resection, and are able to provide a tissue sample for personalized neoantigen DNA vaccine development.
Interventions
BIOLOGICALGNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation
delivered by intradermal injection and electroporation
DEVICEElectroporation Device
GNOS-PV02 + INO-9012 ID followed by electroporation
BIOLOGICALINO-9012
cytokine interleukin-12 (IL-12), a vaccine adjuvant
Sponsors
Geneos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adjuvant Therapy, Active Surveillance
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. ≥18 years of age 3. Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma) 4. Child-Pugh Class A liver score 5. Documented virology status of hepatitis 6. Availability of a representative post-resection tumor tissue sample 7. ECOG performance status of 0 or 1 8. Adequate organ function 9. Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception
Exclusion criteria
1. Is currently participating in and receiving study drug or has participated in a study of an investigational agent and received study drug or used an investigation device, within 4 weeks to baseline 2. Evidence of residual, recurrent, or metastatic disease at randomization 3. Active or history of autoimmune disease or immune deficiency 4. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug 5. Diagnosed additional malignancy within 5 years prior to baseline, except for: (a) non-invasive carcinomas subject to successful curative treatment in the opinion of the investigator which require no further therapy and (b) other malignancies for which subjects have undergone potentially curative therapy and have been considered disease free for at least 3 years prior to screening. 6. Active infection requiring systemic therapy 7. Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration 8. History of human immunodeficiency virus (HIV) (HIV I/II antibodies). 9. Co-infection with HBV and hepatitis D viral infection 10. Co-infection with HBV and HCV 11. Has received a live vaccine within 30 days of planned start of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | Up to 5 years | RFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary HCC, as assessed by the investigator, or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events (safety and tolerability) | Up to 5 years | Summary adverse events according to CTCAE 6.0 |
| Time to extra-hepatic spread or macro-vascular invasion | Up to 5 years | Time to extra-hepatic spread or macro-vascular invasion (TTEHS/MVI) |
| Overall survival | Up to 5 years on study + 3 years follow up | OS is defined as time from randomization to death of any cause |
| RFS rate at 12, 18 and 24 months as assessed by the investigator | Randomization up to 12 months, 18 and 24 months | The proportion of patients who remain free from disease recurrence after treatment over a specified period |
| RFS rate at 12, 18 and 24 months as assessed by the BIRC | Randomization up to 12 months, 18 months and 24 months | The proportion of patients who remain free from disease recurrence after treatment over a specified period |
Countries
New Zealand, United States
Contacts
CONTACTJoann Peters, MHA
Outcome results
None listed