eoadjuvant immune checkpoint inhibition and novel IO combinations in early-stage colon cancer. The NICHE trial. - Neoadjuvant Immunotherapy in early stage colon cancers (NICHE)

ederlands Kanker Instituut0 个研究点目标入组 268 人开始时间: 待定最近更新: 2024年4月23日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 268

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

年龄范围: 18 至 99（—）

入选标准

•Signed written informed consent;
•Patients at least 18 years of age;
•Non-metastatic adenocarcinoma of the colon (and rectosigmoid considered as
•non-rectal and not undergoing neoadjuvant treatment)
•o No signs of distant metastases on CT-scan and physical examination;
•o dMMR cohorts 3+6: >cT3 and/or N+
•No clinical obstruction;
•No clinical symptoms or radiological suspicion of perforation;
•Colonoscopy must be performed after informed consent to obtain study-specific
•biopsies. If biopsies are not possible, patients cannot be included in the
•WHO performance status of 0 or 1;
•Screening laboratory tests must meet the following criteria and should be
•obtained within 7 days prior to randomization/registration: WBC > 2.0 x 10^9/L,
•ANC > 1.5x10^9/L, platelets > 100 x 10^9/L, Hemoglobin > 5.0mmol/L. Transfusion
•is allowed to obtain an adequate hemoglobin level. Liver function tests: total
•< 1.5 upper limit of normal (ULN) (except for subjects with Gilbert syndrome,
•who can have total bilirubin <3.0 mg/dL); alkaline phosphatase <2.5 ULN;
•transaminases (ASAT/ALAT) <3 x ULN; LDH < 2 x ULN;
•Creatinine clearance (Cockcroft-Gault) of >40 ml/min;
•Women of childbearing potential (WOCBP)* must use appropriate method(s) of
•contraception. WOCBP should use an adequate method to avoid pregnancy for 23
•weeks (30 days plus the time required for nivolumab to undergo five half-lives)
•after the last dose of investigational drug;
•Women of childbearing potential must have a negative serum or urine pregnancy
•test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours
•prior to the start of nivolumab;
•Men who are sexually active with WOCBP must use any contraceptive method with
•a failure rate of less than 1% per year. Men receiving nivolumab and who are
•sexually active with WOCBP will be instructed to adhere to contraception for a
•period of 31 weeks after the last dose of investigational product. Women who
•are not of childbearing potential (i.e., who are postmenopausal or surgically
•sterile as well as azoospermic men do not require contraception;
•CT-scan must be performed within 28 days prior to registration;
•No previous treatment with immune checkpoint inhibitors targeting including
•but not limited to CTLA-4, PD-1 or PD-L1;
•No previous treatment with chemotherapy for colon cancer.
•o For dMMR cohort no previous chemotherapy for any malignancies
•No radiotherapy prior to or planned post-surgery radiotherapy for disease
•under study;
•No active malignancies other than disease under study within 3 years prior to
•inclusion, except for malignancies with a negligible recurrence rate (e.g. <10%
•in 5 years);
•Allergies and Adverse Drug Reaction
•o No history of allergy to study drug components
•o No history of severe hypersensitivity reaction to any monoclonal antibody
•No intercurrent illnesses, including but not limited to infections, unstable
•angina pectoris;
•No underlying medical conditions that, in the Investigator*s opinion, will
•make the administration of the study drug hazardous or obscure the
•interpretation of toxicity determination of adverse events;
另有 2 项未显示

排除标准

•(No) previous treatment with immune checkpoint inhibitors targeting CTLA-4,
•PD-1 or PD-L1;
•No radiotherapy prior to or planned post-surgery radiotherapy within this
•Allergies and Adverse Drug Reaction
•O No history of allergy to study drug components
•O No history of severe hypersensitivity reaction to any monoclonal antibody
•O No history of allergy or severe hypersensitivity to NSAIDs or COX2-I (MSS
•No intercurrent illnesses, including but not limited to infections, unstable
•angina pectoris
•No positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C
•virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
•No live vaccines in the 4 weeks prior to inclusion;
•For patients with MSS tumors: no current use of NSAIDs or COX2-inhibitors at
•registration and no active peptic ulcer, gastrointestinal bleeding, unstable
•ischemic heart disease of thrombus etiology or significant established ischemic
•heart disease, peripheral arterial disease and/or cerebrovascular disease;
•No underlying medical conditions that, in the Investigator*s opinion, will
•make the administration of the study drug hazardous or obscure the
•interpretation of toxicity determination of adverse events;
•No active autoimmune disease or a documented history of autoimmune disease,
•or other medical conditions requiring systemic steroid or immunosuppressive
•medications, except for subjects with vitiligo, diabetes mellitus type 1,
•residual hypothyroidism due to autoimmune condition only requiring hormone
•replacement, psoriasis or resolved childhood asthma/atopy not requiring
•systemic treatment;
•No conditions requiring systemic treatment with either corticosteroids (> 10
•mg daily prednisone equivalents) or other immunosuppressive medications within
•14 days of study drug administration. Inhaled or topical steroids and adrenal
•replacement doses > 10 mg daily prednisone equivalents are permitted in the
•absence of active autoimmune disease;
•No history of uncontrolled medical or psychiatric illness;
•No psychological, familial, sociological or geographical condition
•potentially hampering compliance with the study protocol and follow-up
•No current pregnancy or breastfeeding;
•No active malignancies other than disease under study within 3 years prior to
•inclusion, except for malignancies with a negligible recurrence rate (e.g. <10%
•in 5 years).

研究者

发起方

ederlands Kanker Instituut

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