Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-09 @ 1:44 PM
Study NCT ID:
NCT03203005
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMA970A Plus CV8102 in Very Early, Early and Intermediate Stage Hepatocellular Carcinoma Patients
Sponsor:
National Cancer Institute, Naples
Organization:
Study Overview
Official Title:
A Phase I/II Trial of IMA970A Plus CV8102 Following a Single Pre-vaccination Infusion of Cyclophosphamide in Patients With Very Early, Early and Intermediate Stage of Hepatocellular Carcinoma After Any Standard Treatments
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being carried out in order to evaluate a new cancer vaccine called IMA970A combined with CV8102, a new adjuvant for the treatment of liver cancer (hepatocellular carcinoma). It will be investigated whether IMA970A and CV8102 is safe and can trigger an immune response against the tumor, which may prevent the tumor (cancer) from recurring or spreading or may even lead to tumor shrinkage following the standard treatments the patients have previously received.
Detailed Description:
The trial is designed as a single-arm, open-label, multi-center, first-in-man phase I/II study investigating an off-the-shelf, multi-peptide-based HCC vaccine (IMA970A) plus CV8102 adjuvant (RNAdjuvant®) following a single pre-vaccination infusion of low-dose cyclophosphamide (CY) acting as an immunomodulator, in patients with very early, early and intermediate stage HCC.
The study treatment is applied without any concomitant anti-tumor therapy, with the intention to reduce the risk of tumor recurrence/progression in patients who have received all indicated standard treatments.
Overall, it is planned to treat about 40 patients with IMA970A (off-the-shelf vaccine) plus CV8102 (adjuvant) plus a single low-dose of pre-vaccination CY acting as an immunomodulator in the HepaVac-101 study.
Patients are requested to sign the 1st informed consent (IC 1) for screening 1 procedures (blood drawings for Human Leukocyte Antigen (HLA) typing and for cellular immunomonitoring, capture of demographics and staging of disease \[routinely performed, older images may be used if requirements are met\]), which takes up to 4 weeks. Thereafter, patients receive indicated standard treatment followed by recovery, which lasts for at least 4 weeks and up to 12 weeks. The main-phase with full safety surveillance starts with the patient's signature of the 2nd informed consent (IC 2) and lasts until the end of the EoV (End-of-Visit, Visit 10) Visit (4-6 weeks after last vaccination). For each patient this main-phase lasts up to approx. 6.5 months consisting of up to 4 weeks screening 2, about 4.5 months vaccination period and about 4 weeks follow up (until EOV Visit \[Visit 10\]).
The study treatment is applied without any concomitant anti-tumor therapy, with the intention to reduce the risk of tumor recurrence/progression in patients who have received all indicated standard treatments.
Overall, it is planned to treat about 40 patients with IMA970A (off-the-shelf vaccine) plus CV8102 (adjuvant) plus a single low-dose of pre-vaccination CY acting as an immunomodulator in the HepaVac-101 study.
Patients are requested to sign the 1st informed consent (IC 1) for screening 1 procedures (blood drawings for Human Leukocyte Antigen (HLA) typing and for cellular immunomonitoring, capture of demographics and staging of disease \[routinely performed, older images may be used if requirements are met\]), which takes up to 4 weeks. Thereafter, patients receive indicated standard treatment followed by recovery, which lasts for at least 4 weeks and up to 12 weeks. The main-phase with full safety surveillance starts with the patient's signature of the 2nd informed consent (IC 2) and lasts until the end of the EoV (End-of-Visit, Visit 10) Visit (4-6 weeks after last vaccination). For each patient this main-phase lasts up to approx. 6.5 months consisting of up to 4 weeks screening 2, about 4.5 months vaccination period and about 4 weeks follow up (until EOV Visit \[Visit 10\]).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: