HEPAVAC-101 Clinical Trial
IMA970A is a therapeutic cancer vaccine for primary liver cancer based on an off-the-shelf cocktail of 16 peptides, of which 7 are restricted to HLA-A*02; 5 to HLA-A*24 and 4 to HLA class II.
IMA970A, combined with the CV8102 adjuvant (RNAdjuvant®), is going to be evaluated in a single-arm, first-in-man trial entitled HepaVac-101 ,in patients with very early, early and intermediate stage of HCC. Enrollment is predicted to start in Q3 2017. The vaccine administration will follow a single pre-vaccination infusion of low-dose cyclophosphamide acting as an immunomodulator.
A subgroup of enrolled patients will be boosted with a personalized vaccine (APVAC) based on individual mutated antigens.
The IMA970A plus CV8102 are applied without concomitant anti-tumor therapy with the intention to reduce risk of tumor recurrence/progression in patients who have received all indicated standard treatments.
The primary endpoints are safety, tolerability, and immunogenicity. Secondary/exploratory endpoints are additional immunological parameters in blood (e.g. regulatory T-cells, myeloid-derived suppressor cells, impact of the standard therapy on the natural immune response), infiltrating T-lymphocytes in tumor tissue, biomarkers in blood and tissue, disease-free survival/progression-free survival and overall survival.
Below the European and the American trial number:
Europe: EudraCT Number: 2015-003389-10