1487TiP A randomized non-comparative phase II study of maintenance therapy with FOLFIRI alone or in combination with Tedopi vaccine after induction therapy with FOLFIRINOX in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (TEDOPAM – D17-01 PRODIGE 63 STUDY)

Abstract

Tedopi (OSE2101) is a multiple neoepitope vaccine restricted to HLA-A2 positive patients (Pts) targeting 5 tumor-associated antigens (ACE, HER2, MAGE2, MAGE3, TP53) frequently expressed in pancreatic ductal adenocarcinoma (PDAC). The TEDOPaM - PRODIGE 63 aims to assess the efficacy and safety of Tedopi in advanced PDAC Pts after FOLFIRINOX induction chemotherapy (CT). It was initially a randomized, non-comparative phase II study with 3 arms: FOLFIRI, Tedopi, Tedopi + nivolumab. Following the IDMC meeting in July 2020 (N=29 Pts), suggesting that early CT discontinuation may be deleterious, Sponsor decided to stop the evaluation of Tedopi without CT and maintain a CT backbone with FOLFIRI.