A phase 2 trial of EO2040, a miCrobiaL-derived peptide therApeUtic vaccine, in combination with nivolumab, for treatment of patients with circulating tumor DNA-dEfined minimal residual disease of colorectal cancer stage II, III, or IV after completion of curative therapy (the CLAUDE study). - CLAUDE study

Enterome SA0 个研究点目标入组 34 人开始时间: 2022年8月9日最近更新: 2024年2月19日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Enterome SA
入组人数: 34

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1.Provided written informed consent prior to any study-related procedures (Consent #1 is for screening part #1 procedures, Consent #1B specifically for patients recruited in Germany to a prolonged screening for ctDNA after curative resection of liver metastases, and a final Consent #2 for screening part #2 procedures; see Section 7.2 and Section 7.3, respectively).
•2.Histological confirmation of colorectal cancer (confirmation at initial diagnosis is sufficient).
•3.Post R0-resection (i.e. microscopically margin-negative resection and no gross or microscopic tumor remaining in the primary tumor bed) of stages II, III, or IV CRC and completion of all planned standard of care perioperative and/or adjuvant therapies.
•a.Note, if there is doubt the patient has received all relevant standard of care therapy, the patient should be discussed with the trial Medical Monitor, who can also defer the case for decision by the Global Coordinating Investigator.
•4.Presence of minimal residual disease as defined by a positive ctDNA assay after completion of all planned standard of care therapies.
•a.Note, patients may be identified for enrollment with any CLIA-certified, or similar certification outside of the USA, ctDNA assay for MRD as standard of care or in a surveillance trial. However, MRD status will be confirmed with the Signatera assay prior to initiation of study therapy (i.e. within the screening part #2 procedures) for all patients who have not had a Signatera research grade testing where all parameters from the testing can be provided for the current trial.
•5.Age = 18 years old.
•6.Human leukocyte antigen (HLA)-A2 positive.
•7.No evidence of radiographic disease (computer tomography or magnetic resonance imaging; optimized to detect metastatic disease, e.g. with contrast as applicable) that requires immediate therapeutic intervention as assessed by the treating physician, within 28 days of (before or after) a positive ctDNA assay.
•a.Note, if there are lesions on scanning which are highly suspicious for being metastatic CRC even if no immediate therapeutic intervention is needed, this is a clear indication to NOT enroll the patient in the trial. At doubt the case should be discussed with the trial Medical Monitor, who can also defer the case for decision by the Global Coordinating Investigator.
•b.Note, if the scanning is not done within -7 days/+28 days of the positive Signatera assay which is accepted as confirmatory test for the trial, the scanning needs to be repeated within the screening part #2 procedures.
•8.ECOG performance status 0 or 1 (see Section 12.1).
•9.Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to start of study therapy.
•10.Considering the embryofetal toxicity of the immune checkpoint inhibitor (ICI) shown in animals’ models, the following recommendations for contraception must be followed:
•a.If not surgically sterile, female patients of childbearing potential age must use highly effective contraception from signing the Informed Consent Form (ICF) through 6 months after the last treatment dose administered. Highly effective contraception includes (according to Clinical Trial Facilitation Group: Recommendations related to contraception and pregnancy testing in clinical trials [104]):
•i.combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal,
•ii.progestogen-only hormonal contraception

排除标准

•1.Patients treated with dexamethasone > 2 mg/day or equivalent (i.e., 13 mg/day of prednisone) within 14 days before start of study therapy, unless required to treat an adverse event (AE).
•Note: patient should not receive treatment with dexamethasone > 2 mg/day or equivalent at the actual time of a screening visit (single time point assessment), and within 14 days before the start of study treatment (unless required to treat an AE); the latter part of the criterion should be checked at the time of start of treatment.
•2.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.
•3.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.
•4.Patients who have received any prior treatment with compounds targeting PD1, PD-L1, CTLA-4, or similar compounds where general resistance against therapeutic vaccination approaches might have developed.
•5.Patients with the following abnormal laboratory values:
•a.Hemoglobin < 10 g/dL (6.2 mmol/L); transfusion is acceptable to reach the value.
•b.Absolute neutrophil count decrease (<1.5 x109/L).
•c.Platelet count decrease (< 75 ×109/L).
•d.Total bilirubin > 1.5 ×upper limit of normal (ULN; according to the performing laboratory’s reference ranges); except participants with Gilbert Syndrome who must have a total bilirubin level of < 3.0 xULN.
•e.Alanine aminotransferase (ALT) > 3 ×ULN.
•f.Aspartate aminotransferase (AST) > 3 ×ULN.
•g.Serum creatinine increase (> 1.5 ×ULN).
•h.Abnormal thyroid function per local laboratory levels; note, patients with hypothyroidism only requiring hormone replacement therapy, and patients with long term (judged by the treating physician) stable antithyroid therapy due to hyperthyroidism, are permitted to enroll. Patients with abnormal thyroid laboratory values judged by the treating physician as clinically non-relevant are also eligible.
•6.Patients with presence of other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoiesis of unknown potential allowed).
•7.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:
•a.Bacterial sepsis, COVID-19, or other similarly severe infections (clinical assessment is the basis for exclusion of severe infections; if clinical suspicion, adequate testing should be performed to exclude severe infections).
•b.New York Heart Association > Grade 2 congestive heart failure within 6 months prior to start of study therapy (see Section 12.2).
•c.Uncontrolled or significant cardiovascular disease, including:
•i.myocardial infarction within 6 months prior to start of study therapy,
•ii.uncontrolled/unstable angina within 6 months prior to start of study therapy,
•iii.diagnosed or suspected congenital long QT syndrome, and
•iv.any history of clinically significant ventricular arrhythmias
•d.Stroke within 6 months prior to start of study therapy.
•e.Concurrent neurodegenerative disease.

研究者

发起方

Enterome SA

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