Набор скоро начнётся NCT07722741

Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC

Фаза II С лечением HCC

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, Electroporation Device, INO-9012.
Кому может быть актуально: Состояния в реестре: HCC. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Новая Зеландия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Биопрепарат GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation
delivered by intradermal injection and electroporation
Устройство Electroporation Device
GNOS-PV02 + INO-9012 ID followed by electroporation
Биопрепарат INO-9012
cytokine interleukin-12 (IL-12), a vaccine adjuvant

Первичные конечные точки

Recurrence-free survival [Срок оценки: Up to 5 years]

Вторичные конечные точки (3)

Incidence of treatment emergent adverse events (safety and tolerability) [Срок оценки: Up to 5 years]
Time to extra-hepatic spread or macro-vascular invasion [Срок оценки: Up to 5 years]
Overall survival [Срок оценки: Up to 5 years on study + 3 years follow up]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет