Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INO-9012 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Personalized Immunotherapy for Cancer: | EXPERIMENTAL | GNOS-PV02 + INO-9012 ID followed by electroporation every 3 weeks for 4 doses, then every 9 weeks (Q9W) until week 104, then every 12 weeks (Q12W) until week 260 followed by 3 years follow-up survival |
| Standard of Care | NO_INTERVENTION | Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival. |
| Name | Type | Description |
|---|---|---|
| GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation | BIOLOGICAL | delivered by intradermal injection and electroporation |
| Electroporation Device | DEVICE | GNOS-PV02 + INO-9012 ID followed by electroporation |
| INO-9012 | BIOLOGICAL | cytokine interleukin-12 (IL-12), a vaccine adjuvant |
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 re...