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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
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.
MD Anderson
Houston, Texas, United States
Response to Treatment at 6 Months
Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence
Time frame: 6 months
Treatment-Emergent Adverse Events
Number and percentage of patients with Treatment-Emergent Adverse Events (TEAEs)
Time frame: 7 months
Serious Adverse Events
Number and percentage of patients with Serious Adverse Events (SAEs )
Time frame: 7 months
NCI-CTCAE Grading
Number and percentage of patients with at least one NCI-CTCAE v5.0 grade increase or decrease
Time frame: 7 months
Response to Therapy at 3 Months
Percentage of patients with ctDNA clearance and no radiographic evidence of recurrence
Time frame: 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,
Time frame: 7 months
Overall Survival
Overall survival (OS), measured as the time from start of study treatment until death from any cause.
Time frame: 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.
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Time frame: 6 months