Status:
TERMINATED
EO2040 in Combination With Nivolumab, for Treatment of Patients With Minimal Residual Disease of Colorectal Cancer
Lead Sponsor:
Enterome
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 colorec...
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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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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Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05350501
Start Date
March 1 2023
End Date
January 23 2024
Last Update
September 29 2025
Active Locations (1)
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1
MD Anderson
Houston, Texas, United States, 77030