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HepaVac-101 first-in-man therapeutic cancer vaccine phase I/II clinical trial for hepatocellular carcinoma patients.

2018; Lippincott Williams & Wilkins; Volume: 36; Issue: 15_suppl Linguagem: Inglês

10.1200/jco.2018.36.15_suppl.tps3135

1527-7755

Luigi Buonaguro, Andrea Mayer-Mokler, Roberto S. Accolla, Yuk Ting, Regina Heidenreich, Antonio Avallone, Ester Simeone, Alfred Koenigsrainer, Markus Loeffler, Cécile Gouttefangeas, Christian Flohr, Joerg Ludwig, Hans‐Georg Rammensee, Mercedes Iñarrairaegui, Sven Francque, Tanguy Chaumette, Toni Weinschenk, Carsten Reinhardt, Senta Ulrike Gnad-Vogt, Harpreet Singh,

vaccines and immunoinformatics approaches

TPS3135 Background: HCC is the third leading cause of death from cancer globally with an extremely variable 5-year survival rate. The HepaVac-101 phase I/II, first-in-man, therapeutic cancer vaccine single-arm clinical trial is performed as part of the HepaVac project, funded by the European Commission's 7th Framework Program under the Grant Agreement Nr. 602893 (www.hepavac.eu). The HepaVac-101 trial identification numbers are NCT03203005 (Clinical trials.gov) and 2015-003389-10 (EudraCT). and Methods: The therapeutic cancer vaccine IMA970A is a multi-peptide-based HCC vaccine composed of 16 newly discovered and overexpressed tumor-associated peptides (TUMAPs) directly identified from resected HCC tissues. Of these TUMAPs, 7 are restricted to HLA-A*02, 5 to HLA-A*24 and 4 to HLA class II. CV8102 is a novel RNA based immunostimulatory agent inducing a balanced Th1/Th2 immune response. A total of 40 patients with very early, early and intermediate stage of HCC are enrolled to be treated with a single pre-vaccination infusion of low-dose cyclophosphamide, followed by 9 intradermal vaccinations consisting of IMA970A plus CV8102. The study drugs are applied without concomitant anti-tumor therapy, in order to reduce risk of tumor recurrence/progression in patients having received all indicated standard treatments and without evidence of active disease. The primary endpoints of the HepaVac-101 clinical trial are safety, tolerability, and immunogenicity. Secondary/exploratory endpoints are additional immunological parameters in circulation, infiltrating T-lymphocytes in tumor tissue, biomarkers in blood and tissue, DFS/PFS and OS. Once safety of this vaccination approach has been established in the first 10 patients the addition of a checkpoint inhibitor will be considered. Suitable patients enrolled at Tuebingen are invited to participate in a trial extension investigating an actively personalized vaccine (APVAC). The HepaVac-101 trial is conducted in 6 centers located in 5 European countries. Five centers are actively recruiting patients. As of the time of abstract submission, 4 HCC patients have been screened for HLA haplotype and 1 is eligible for vaccination. Clinical trial information: NCT03203005.