Abstract 1563
Background
FOLFIRINOX (5FU, folinic acid [FA], irinotecan [Iri], oxaliplatin [Ox]) is a 1st-line standard in fit Pts with aPDAC. Anti-PD-(L)1 as single agents have failed in aPDAC and new combination immunotherapies are needed. Tedopi (OSE2101) is a multiple neoepitope vaccine restricted to HLA-A2 positive Pts targeting 5 tumor-associated antigens (ACE, HER2, MAGE2, MAGE3, TP53) frequently expressed in PDAC. This study aims to assess the efficacy and safety of Tedopi alone and in combination with anti-PD-1 nivolumab or FOLFIRI as maintenance therapy in aPDAC Pts after FOLFIRINOX induction CT.
Trial design
TEDOPaM is a 3-arm, Fleming 2-stage, open-label, randomized, non-comparative phase II study. 156 Pts with recurrent or advanced, pathologically proven PDAC; ECOG PS 0-1; HLA-A2 genotype; controlled disease (PR or SD) after 8 cycles of FOLFIRINOX; adequate organ functions, are randomized (1:1:1, stratified on center, tumor stage, best response to FOLFIRINOX) into 3 arms:Table:
830TiP
Arm A (reference): FOLFIRI (n = 52) | IV; FA 400 mg/m2, Iri 180 mg/m2, 5FU bolus 400 mg/m2 + continuous 2400 mg/m2/46h |
Arm B: Tedopi (n = 52) | Subcutaneous injection on D1 Q3W/6 doses then Q8W until month 12 [M12] then Q12W up to M24 |
Arm C: Tedopi + nivolumab (n = 52) | Tedopi + nivolumab 360 mg IV on D1 Q3W/6 doses then 480 mg Q4W up to M24 |
In Arms B and C, reintroduction of FOLFIRI at disease progression or unacceptable toxicity. Primary endpoint: overall survival rate at M12. Secondary: progression-free survival (CT-scan Q8W), duration of disease control, safety, response rate, RECIST v1.1/iRECIST comparison, HRQoL, Q-TWiST. Interim analysis after inclusion of 20 Pts in each arm. Translational research on tumor tissue (initial FFPE biopsy and optional re-biopsy at inclusion): RNAseq (cancer and stroma), mutation burden, MMR status, immune infiltrates; and in blood (before and on-treatment): cytokine panel, PBMC phenotyping, vaccine-antigen specific T-cells, TCR repertoire, extracellular vesicles to explore biomarkers and pharmacodynamics effects of Tedopi ± nivolumab.
Clinical trial identification
NCT03806309.
Editorial acknowledgement
Legal entity responsible for the study
GERCOR.
Funding
OSE Immunotherapeutics.
Disclosure
C. Neuzillet: Honoraria (self), Not related to the abstract: Amgen; Honoraria (self), Not related to the abstract: AstraZeneca; Research grant / Funding (institution), Not related to the abstract: Celgene; Honoraria (self), Travel / Accommodation / Expenses, Not related to the abstract: MSD; Research grant / Funding (institution), Travel / Accommodation / Expenses, PI of the TEDOPaM Clinical Trial: OSE Immunotherapeutics; Honoraria (self), Not related to the abstract: Roche; Honoraria (self), Not related to the abstract: Servier. V. Hautefeuille: Honoraria (self), Not related to the abstract: Amgen; Honoraria (self), Not related to the abstract: Novartis; Honoraria (self), Not related to the abstract: Ipsen; Honoraria (self), Not related to the abstract: Pfizer; Honoraria (self), Not related to the abstract: AAA; Honoraria (self), Not related to the abstract: Sanofi; Honoraria (self), Not related to the abstract: Merck; Honoraria (self), Not related to the abstract: Servier; Honoraria (self), Not related to the abstract: Lilly. A. Lambert: Advisory / Consultancy: Janssen; Advisory / Consultancy: Merck KGaA; Advisory / Consultancy: Bayer; Honoraria (self): Servier/Pfizer. D. Vernerey: Advisory / Consultancy: OSE Immunotherapeutics; Advisory / Consultancy: HalioDX; Advisory / Consultancy: Pfizer; Advisory / Consultancy: CellProthera. All other authors have declared no conflicts of interest.
Resources from the same session
2078 - Comprehensive genomic profiling and clinical outcomes in patients (pts) with fibroblast growth factor receptor rearrangement-positive (FGFR2+) cholangiocarcinoma (CCA) treated with pemigatinib in the fight-202 trial
Presenter: Antoine Hollebecque
Session: Poster Display session 2
Resources:
Abstract
3879 - Efficacy of derazantinib (DZB) in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) expressing FGFR2-fusion or FGFR2 mutations/amplifications
Presenter: Michele Droz Dit Busset
Session: Poster Display session 2
Resources:
Abstract
4679 - It’s Not Only About Weight Loss: Tackling Pancreatic Cancer-Associated Cachexia
Presenter: Ana Leonor Matos
Session: Poster Display session 2
Resources:
Abstract
2276 - Frequency and clinicopathological characteristics of biliary tract carcinomas harboring the FGFR2-fusion gene: a prospective observational study (PRELUDE study)
Presenter: Masafumi Ikeda
Session: Poster Display session 2
Resources:
Abstract
2773 - Post-hoc analyses of a subgroup of patients with advanced biliary tract cancer (BTC) who crossed over to treatment with etoposide toniribate (EDO-S7.1) in a randomized Phase II study
Presenter: Ulrich-Frank Pape
Session: Poster Display session 2
Resources:
Abstract
4479 - Capecitabine +Best supportive care (BSC) or Erlotinib +BSC has Overall survival (OS) benefit over BSC alone in unresectable/metastatic Gall bladder cancer(GBC) patients with ECOG PS-III. Results from a phase II Randomised controlled trial (RCT)
Presenter: Babita Kataria
Session: Poster Display session 2
Resources:
Abstract
4843 - FGFR2 fusions and its effect of patient (pt) outcomes in intrahepatic cholangiocarcinoma (iCCA)
Presenter: Daniel Almquist
Session: Poster Display session 2
Resources:
Abstract
2324 - The Clinical Outcomes of Systemic Chemotherapy in Patients with Unresectable or Metastatic Combined Hepatocellular-cholangiocarcinoma (HCC-CCA): Retrospective Study of 120 Patients
Presenter: Eojin Kim
Session: Poster Display session 2
Resources:
Abstract
3678 - High PD-L1 expression is associated with treatment response to pembrolizumab in patients with advanced biliary tract cancer.
Presenter: Gilhyang Kim
Session: Poster Display session 2
Resources:
Abstract
3901 - Genomic profiling in Chinese biliary tract cancer patients with PI3K/AKT/mTOR pathway and RAS gene mutations
Presenter: Jingyu Cao
Session: Poster Display session 2
Resources:
Abstract