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EO2040 in Combination With Nivolumab, for Treatment of Patients With Minimal Residual Disease of Colorectal Cancer

NCT05350501 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-09-29

Study results available
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Summary

The current study will evaluate the microbiome-derived therapeutic vaccine EO2040 in combination with nivolumab in patients with circulating tumor DNA-defined Minimal Residual Disease (MRD) of colorectal cancer stage II, III, or IV after completion of standard curative therapy.

Conditions

Interventions

DRUG

EO2040

EO2040, is a therapeutic peptide vaccine composed of two microbial-derived peptides mimicking cytotoxic T cell (CD8+ T cell) epitopes from the Tumor Associated Antigens (TAAs) combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). The peptide mix EO2040, i.e. drug product (DP), will be emulsified with the adjuvant Montanide. EO2040 will be given in combination with nivolumab, which is an anti-PD1. Nivolumab is approved for use for the treatment of multiple cancer types, including subtypes of CRC (mismatch repair deficient or microsatellite instability-high metastatic disease after prior treatment). However, it is not currently approved for ctDNA defined MRD of CRC.

Sponsors & Collaborators

  • Enterome

    lead INDUSTRY

Principal Investigators

  • Jan Fagerberg, MD · Enterome

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-01-23
Completion
2024-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350501 on ClinicalTrials.gov