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

NCT05350501 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: EOCRC1-22
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Response to Treatment at 6 Months

  Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence

  6 months

Secondary Outcomes (7)

• Treatment-Emergent Adverse Events

  7 months

• Serious Adverse Events

  7 months

• NCI-CTCAE Grading

  7 months

• Response to Therapy at 3 Months

  3 months

• DIsease-free Survival

  7 months

Study Arms (1)

Patients With Minimal Residual Disease of Colorectal Cancer

EXPERIMENTAL

Patients With Circulating Tumor DNA-defined Minimal Residual Disease of Colorectal Cancer Stage II, III, or IV After Completion of Curative Therapy

Drug: EO2040

Interventions

EO2040 DRUG

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.

Also known as: Nivolumab

Patients With Minimal Residual Disease of Colorectal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to receive study treatment, a patient must meet all the criteria below:
• Provided written informed consent prior to any study-related procedures .
• Histological confirmation of colorectal cancer.
• Post R0-resection of stages II, III, or IV CRC and completion of all planned standard of care adjuvant therapies.
• Presence of minimal residual disease as defined by a positive ctDNA assay after completion of all planned standard of care therapies.
• Age ≥ 18 years old.
• Human leukocyte antigen (HLA)-A2 positive.
• No evidence of radiographic disease
• Predefined performance status
• Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to randomization.
• Considering the embryofetal toxicity of the immune checkpoint inhibitor (ICI) shown in animals' models, recommendations for contraception must be followed.
• Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

You may not qualify if:

• Patients who meet any of the following criteria will not be eligible to participate in the study:
• Patients treated with dexamethasone \> 2 mg/day or equivalent .
• Patients 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.
• Patients with persistent Grade ≥ 2 toxicities (according to NCI-CTCAE v5.0). Toxicities must be resolved for at least 2 weeks to Grade 1 or less. However, alopecia, neuropathy, and other persisting toxicities not constituting a safety risk based on Investigator's judgment are acceptable.
• Patients who have received any prior treatment with compounds targeting PD1, PD-L1, Cytotoxic T-lymphocyte-associated Antigen 4 (CTLA-4), or similar compounds where general resistance against therapeutic vaccination approaches might have developed.
• Patients with defined abnormal laboratory values:
• Patients with presence of other concomitant active, invasive malignancies .
• Patients 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 suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome)..
• Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Patients with a history or known presence of tuberculosis.
• Pregnant and breastfeeding patients.
• Patients with a history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV).
• Patients who have received live or attenuated vaccine therapy used for prevention of infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the first dose of study drug.
• Patients with a history of hypersensitivity to any excipient, or active substance, present in the pharmaceutical forms of applicable study treatments.

Sponsors & Collaborators

• Enterome: lead

Study Sites (1)

MD Anderson

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr Jan Fagerberg
• Organization: Enterome

info@enterome.com

+33175772785

Study Officials

• Jan Fagerberg, MD

  Enterome

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 28, 2022
• Study Start: March 1, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: September 29, 2025
• Results First Posted: December 19, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)