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
3266 - Morphology of tumor-associated macrophages dictates the prognosis of patients with colorectal liver metastases.
Presenter: Matteo Donadon
Session: Poster Display session 2
Resources:
Abstract
1694 - Pembrolizumab (pembro) Plus mFOLFOX or FOLFIRI in Patients With Metastatic Colorectal Cancer (mCRC): KEYNOTE-651 Cohorts B and D
Presenter: Richard Kim
Session: Poster Display session 2
Resources:
Abstract
908 - Romidepsin (FK228) Regulates the Expression of the Immune Checkpoint Ligand PD-L1 and Exerts Synergistic Anti-Tumor Activity with an Anti-PD-1 Antibody in Colon Cancer
Presenter: Hui Li
Session: Poster Display session 2
Resources:
Abstract
3127 - Prognostic significance of circulating regulatory T lymphocytes (Tregs) in patients with metastatic colorectal cancer (mCRC) under treatment with first line chemotherapy.
Presenter: Zafeiris Zafeiriou
Session: Poster Display session 2
Resources:
Abstract
5416 - The SAFFO study: Sex-related prognostic role And cut-oFf deFinition of monocyte-to-lymphocyte ratio (MLR) in metastatic colOrectal cancer
Presenter: Camilla Lisanti
Session: Poster Display session 2
Resources:
Abstract
2518 - SPICE, a phase I study of enadenotucirev in combination with nivolumab in tumors of epithelial origin: analysis of the metastatic colorectal cancer patients in the dose escalation phase
Presenter: Marwan Fakih
Session: Poster Display session 2
Resources:
Abstract
4000 - Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer
Presenter: Niels Halama
Session: Poster Display session 2
Resources:
Abstract
2223 - Microsatellite Instability Status in Metastatic Colorectal Cancer and Effect of Immune Checkpoint Inhibitors on Survival in MSI-High Metastatic Colorectal Cancer
Presenter: Wataru Okamoto
Session: Poster Display session 2
Resources:
Abstract
2569 - Phase II trial of Trametinib (T) and Panitumumab (Pmab) in RAS/RAF wild type (wt) metastatic colorectal cancer (mCRC)
Presenter: Kanan Alshammari
Session: Poster Display session 2
Resources:
Abstract
5402 - Microsatellite instability and immunogenicity in colorectal cancer – do resident memory Tcells (Trm) play a role in colorectal cancer
Presenter: Wei Toh
Session: Poster Display session 2
Resources:
Abstract