A clinical trial to investigate EO4010, a novel cancer vaccine therapy, with an immune checkpoint blocker, in patients with previously treated metastatic colorectal carcinoma.
Key facts
- Where
- Besancon Cedex, Montpellier Cedex 5 és Paris Cedex 12, FranciaországSee the 3 sites
- Phase
- 1/2. fázis
Where in Franciaország
- CHU BesanconBesancon Cedex, FranciaországNo longer taking part
- Institut Regional Du Cancer De MontpellierMontpellier Cedex 5, FranciaországNo longer taking part
- Hopital Saint AntoineParis Cedex 12, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Enterome
- Trial code
- EU 2023-509509-62-00
- Record updated
- 2025. június 11.
- Original description
The primary objective of this trial is to evaluate safety and tolerability of EO4010 in combination with nivolumab and/or with bevacizumab in patients with unresectable, previously treated locally advanced or mCRC.Read full original descriptionShow less
A global multicenter phase 1/2 trial of EO4010, a novel microbial-derived peptide therapeutic vaccine, in combination with nivolumab and/or bevacizumab, for treatment of patients with previously treated metastatic colorectal carcinoma (the "AUDREY" study).
The primary objective of this trial is to evaluate safety and tolerability of EO4010 in combination with nivolumab and/or with bevacizumab in patients with unresectable, previously treated locally advanced or mCRC.
Inclusion: HLA-A2 positive patients with advanced non-resectable colorectal adenocarcinoma which is mismatch repair proficient and microsatellite stable, who have been previously treated with, or are not considered candidates therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents; Progression during or within 3 months following the latest administration of standard therapies (outlined above); at an age ≥ 18 years; ECOG performance status 0 to 1.
Exclusion: patients treated with dexamethasone > 2 mg/day or equivalent (i.e., 13 mg/day of prednisone) within 14 days before first administration of EO4010; who have received any prior treatment with compounds targeting PD1, PD-L1, CTLA-4, or similar compounds, trifluridine/tipiracil (TAS-102) or regorafenib; treated with radiotherapy within 12 weeks, and cytotoxic chemotherapy therapy within 28 days (or 5 half-lives of the compound(s) administered if longer) before study treatment start; with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition that, in the opinion of the Investigator, would interfere with the interpretation of patient safety or study results or that would prohibit the understanding or rendering of informed consent; Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation; history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV); with the significant abnormal laboratory values hematology, liver and renal function; With persistent Grade ≥ 2 toxicities (according to NCI-CTCAE v5.0). except alopecia, neuropathy, and other persisting toxicities not constituting a safety risk based on Investigator’s judgment; With uncontrolled central nervous system (CNS) metastasis.