Colorectal CancerPhase 2CLAUDENCT05350501
EO2040 in Combination With Nivolumab, for Treatment of Patients With Minimal Residual Disease of Colorectal Cancer
A Phase 2 study testing EO2040 in people with Colorectal Cancer, run by Enterome at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- EO2040
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 23 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
- Patients under treatment with immunostimulatory or immunosuppressive medications, including herbal remedies, or herbal remedies known to potentially interfere with major organ function.
- Patients who have received treatment with any other investigational agent, or participation in another clinical trial
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Trial of EO2040, a miCrobiaL-derived Peptide therApeUtic Vaccine, in Combination With Nivolumab, for Treatment of Patients With ctDNA-dEfined Minimal Residual Disease of CRC Stage II, III, or IV After Curative Therapy
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.
Read the detailed description
The microbiome-derived therapeutic vaccine concept utilized in conjunction with anti-Programmed cell Death protein 1 (PD1) blockade is an innovative option for testing of a rational immunotherapy in colorectal cancer. The concept as such, including the combination with nivolumab, has already been tested in the clinical setting (i.e. in recurrent glioblastoma and adrenal tumors) and shown to be well tolerated.
- Conditions
- Colorectal Cancer
- Being tested
- EO2040
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EO2040Drug
Also called Nivolumab
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: EO2040 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Treatment at 6 Months
Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence
Measured: 6 months
Secondary outcomes (7)
Treatment-Emergent Adverse Events
Number and percentage of patients with Treatment-Emergent Adverse Events (TEAEs)
Measured: 7 months
Serious Adverse Events
Number and percentage of patients with Serious Adverse Events (SAEs )
Measured: 7 months
NCI-CTCAE Grading
Number and percentage of patients with at least one NCI-CTCAE v5.0 grade increase or decrease
Measured: 7 months
Response to Therapy at 3 Months
Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence
Measured: 3 months
DIsease-free Survival
Disease-free survival (DFS) defined as the time from start of study treatment to the date of first documented colorectal cancer (CRC) recurrence or death due to any cause,
Measured: 7 months
Overall Survival
Overall survival (OS), measured as the time from start of study treatment until death from any cause.
Measured: 7 months
Immunogenicity and Cross-reactivity
Percentage of patients with a positive tetramer staining in peripheral blood mononuclear cells for the two microbial-derived peptides which are part of the therapeutic vaccine EO2040.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Mar 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Why it stopped: the study recruitment is significantly behind expectations as only one single patient has started treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enterome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Fagerberg, MD, Study director, Enterome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350501
- Sponsor's protocol ID
- EOCRC1-22
- Acronym
- CLAUDE
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2022
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of EO2040, a miCrobiaL-derived Peptide therApeUtic Vaccine, in Combination With Nivolumab, for Treatment of Patients With ctDNA-dEfined Minimal Residual Disease of CRC Stage II, III, or IV After Curative Therapy
- ClinicalTrials.gov ID
- NCT05350501
- Acronym / sponsor ID
- CLAUDE / EOCRC1-22
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study recruitment is significantly behind expectations as only one single patient has started treatment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- EnteromeIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The microbiome-derived therapeutic vaccine concept utilized in conjunction with anti-Programmed cell Death protein 1 (PD1) blockade is an innovative option for testing of a rational immunotherapy in colorectal cancer. The concept as such, including the combination with nivolumab, has already been tested in the clinical setting (i.e. in recurrent glioblastoma and adrenal tumors) and shown to be well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Minimal Residual Disease of Colorectal Cancer | Experimental | Drug: EO2040Patients With Circulating Tumor DNA-defined Minimal Residual Disease of Colorectal Cancer Stage II, III, or IV After Completion of Curative Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EO2040Also: NivolumabEO2040, 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. | Drug | Patients With Minimal Residual Disease of Colorectal Cancer |
Primary outcome
Response to Treatment at 6 Months
Time frame: 6 months
Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence
7 secondary outcomes
Treatment-Emergent Adverse Events
Time frame: 7 months
Serious Adverse Events
Time frame: 7 months
NCI-CTCAE Grading
Time frame: 7 months
Response to Therapy at 3 Months
Time frame: 3 months
DIsease-free Survival
Time frame: 7 months
Overall Survival
Time frame: 7 months
Immunogenicity and Cross-reactivity
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Fagerberg, MD study director
Enterome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EO2040 in people with Colorectal Cancer, run by Enterome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to Treatment at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.