GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC (NCT04251117) | Clinical Trial Compass
Active β Not RecruitingPhase 1/2
GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC
United States, New Zealand36 participantsStarted 2020-03-01
Plain-language summary
This is a single-arm, open-label, multi-site Phase I/IIa study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in combination with pembrolizumab (MK-3475) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Be willing and able to provide written informed consent for the study. The subject may also provide consent for Future Biomedical Research (FBR). However, the subject may participate in the main study without participating in FBR.
β. 18 years of age on day of signing informed consent.
β. Have histologically or cytologically confirmed diagnosis of HCC based on pathology report. Radiological diagnosis is valid to initiate screening pending confirmation by pathology.
β. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy, or refractory to locoregional therapy, and not amenable to a curative treatment approach.
β. Have a Child-Pugh Class A liver score.
β. Have a predicted life expectancy of greater than 6 months.
β. Have measurable disease based on RECIST 1.1.
β. Have a performance status of 0 or 1 using the ECOG Performance Scale within 7 days of first dose of study drug.
Exclusion criteria
β. Is currently participating 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 of the first dose of treatment. Subjects must also have recovered from associated therapy (i.e., to Grade β€1 or baseline) and from AEs due to any prior therapy.
β. Has received sorafenib or lenvatinib within 14 days of first dose of study drug.
What they're measuring
1
Adverse evets as graded by CTCAE v5.0
Timeframe: Up to 24 Months
2
Immunogenicity of a personalized neoantigen DNA vaccine as measured by interferon-Ξ³ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Timeframe: Up to 24 Months
3
Immunogenicity of a personalized neoantigen DNA vaccine as measured by T-cell activation and cytolytic cell phenotype in PBMCs using Flow Cytometry
β. Has had esophageal or gastric variceal bleeding within the last 6 months. If suspected, subjects will be screened for esophageal varices. If varices are present, they should be treated according to institutional standards before starting study treatment.
β. Has clinically apparent ascites on physical examination. Note: only ascites detectable on imaging studies is allowed.
β. Evidence of portal vein invasion based on imaging is allowed pending subjects meet laboratory criteria for enrollment.
β. Has had encephalopathy in the last 6 months. Subjects on rifaximin or lactulose to control their encephalopathy are not allowed.
β. Had a solid organ or hematologic transplant.
β. Had prior systemic therapy for HCC other than sorafenib or lenvatinib.