Trial Outcomes & Findings for EO2040 in Combination With Nivolumab, for Treatment of Patients With Minimal Residual Disease of Colorectal Cancer (NCT NCT05350501)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2025-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants
BMI	39 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
Response to Treatment at 6 Months	0 Participants

SECONDARY outcome

Timeframe: 7 months

Number and percentage of patients with Treatment-Emergent Adverse Events (TEAEs)

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
Treatment-Emergent Adverse Events	1 Participants

SECONDARY outcome

Timeframe: 7 months

Number and percentage of patients with Serious Adverse Events (SAEs )

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
Serious Adverse Events	1 Participants

SECONDARY outcome

Timeframe: 7 months

Number and percentage of patients with at least one NCI-CTCAE v5.0 grade increase or decrease

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
NCI-CTCAE Grading	1 Participants

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
Response to Therapy at 3 Months	0 Participants

SECONDARY outcome

Timeframe: 7 months

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,

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
DIsease-free Survival	14 weeks

SECONDARY outcome

Timeframe: 7 months

Overall survival (OS), measured as the time from start of study treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
Overall Survival	7 months

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 Participants 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.
Immunogenicity and Cross-reactivity	1 Participants

Adverse Events

Patients With Minimal Residual Disease of Colorectal Cancer

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 participants at risk 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.
General disorders Injection site reaction	100.0% 1/1 • Number of events 1 • 7 months 1

Other adverse events

Other adverse events
Measure	Patients With Minimal Residual Disease of Colorectal Cancer n=1 participants at risk 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.
Metabolism and nutrition disorders Hyperglycemia	100.0% 1/1 • Number of events 1 • 7 months 1
General disorders Pyrexia	100.0% 1/1 • Number of events 1 • 7 months 1
Infections and infestations Rash pustular	100.0% 1/1 • Number of events 1 • 7 months 1
Investigations Blood thyroid stimulating hormone decreased	100.0% 1/1 • Number of events 1 • 7 months 1
Investigations Blood creatinine increased	100.0% 1/1 • Number of events 1 • 7 months 1
Endocrine disorders Hypothyroidism	100.0% 1/1 • Number of events 1 • 7 months 1

Additional Information

Dr Jan Fagerberg

Enterome

Phone: +33175772785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place