IMPACT31: A Randomized Open-label, Multi-center, Phase II Adjuvant Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 18
- 主要终点
- Recurrence-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •≥18 years of age
- •Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma)
- •Child-Pugh Class A liver score
- •Documented virology status of hepatitis
- •Availability of a representative post-resection tumor tissue sample
- •ECOG performance status of 0 or 1
- •Adequate organ function
- •Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception
排除标准
- •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
- •Evidence of residual, recurrent, or metastatic disease at randomization
- •Active or history of autoimmune disease or immune deficiency
- •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
- •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.
- •Active infection requiring systemic therapy
- •Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration
- •History of human immunodeficiency virus (HIV) (HIV I/II antibodies).
- •Co-infection with HBV and hepatitis D viral infection
- •Co-infection with HBV and HCV
- •Has received a live vaccine within 30 days of planned start of study
研究组 & 干预措施
Personalized Immunotherapy for Cancer:
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
干预措施: Electroporation Device (Device)
Personalized Immunotherapy for Cancer:
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
干预措施: GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation (Biological)
Standard of Care
Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival.
Personalized Immunotherapy for Cancer:
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
干预措施: INO-9012 (Biological)
结局指标
主要结局
Recurrence-free survival
时间窗: 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.
次要结局
- Safety and tolerability(Up to 5 years)
- Time to extra-hepatic spread or macro-vascular invasion(Up to 5 years)
- Overall survival(Up to 5 years on study + 3 years follow up)
- Incidence of treatment emergent adverse events (safety and tolerability)(Up to 5 years)
- RFS rate at 12, 18 and 24 months as assessed by the investigator(Randomization up to 12 months, 18 and 24 months)
- RFS rate at 12, 18 and 24 months as assessed by the BIRC(Randomization up to 12 months, 18 months and 24 months)