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the study recruitment is significantly behind expectations as only one single patient has started treatment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response to Treatment at 6 Months | Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events | Number and percentage of patients with Treatment-Emergent Adverse Events (TEAEs) | 7 months |
| Serious Adverse Events | Number and percentage of patients with Serious Adverse Events (SAEs ) |
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Inclusion Criteria:
To be eligible to receive study treatment, a patient must meet all the criteria below:
Exclusion Criteria:
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.
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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| Name | Affiliation | Role |
|---|---|---|
| Jan Fagerberg, MD | Enterome | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Minimal Residual Disease of Colorectal Cancer | Patients With Circulating Tumor DNA-defined Minimal Residual Disease of Colorectal Cancer Stage II, III, or IV After Completion of Curative Therapy 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Minimal Residual Disease of Colorectal Cancer | Patients With Circulating Tumor DNA-defined Minimal Residual Disease of Colorectal Cancer Stage II, III, or IV After Completion of Curative Therapy 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response to Treatment at 6 Months | Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence | Posted | Count of Participants | Participants | 6 months |
|
7 months
1
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Minimal Residual Disease of Colorectal Cancer | Patients With Circulating Tumor DNA-defined Minimal Residual Disease of Colorectal Cancer Stage II, III, or IV After Completion of Curative Therapy 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA (26.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jan Fagerberg | Enterome | +33175772785 | info@enterome.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2022 | Sep 15, 2025 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2024 | Sep 15, 2025 | SAP_004.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 7 months |
| NCI-CTCAE Grading | Number and percentage of patients with at least one NCI-CTCAE v5.0 grade increase or decrease | 7 months |
| Response to Therapy at 3 Months | Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence | 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, | 7 months |
| Overall Survival | Overall survival (OS), measured as the time from start of study treatment until death from any cause. | 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. | 6 months |
| Participants |
| No |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Number | kg/m2 |
|
|
|
| Secondary | Treatment-Emergent Adverse Events | Number and percentage of patients with Treatment-Emergent Adverse Events (TEAEs) | Posted | Count of Participants | Participants | 7 months |
|
|
|
| Secondary | Serious Adverse Events | Number and percentage of patients with Serious Adverse Events (SAEs ) | Posted | Count of Participants | Participants | 7 months |
|
|
|
| Secondary | NCI-CTCAE Grading | Number and percentage of patients with at least one NCI-CTCAE v5.0 grade increase or decrease | Posted | Count of Participants | Participants | 7 months |
|
|
|
| Secondary | Response to Therapy at 3 Months | Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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, | Posted | Number | weeks | 7 months |
|
|
|
| Secondary | Overall Survival | Overall survival (OS), measured as the time from start of study treatment until death from any cause. | Posted | Number | months | 7 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |