Efficacy of immunotherapy in patients with MMR-deficient localized colon cancer scheduled for curative surgery- A prospective, phase II study - Reset

Rigshospitalet0 个研究点目标入组 85 人开始时间: 2021年11月15日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•Have histologically confirmed localized dMMR stage cT1N0M0 to cT4N2M0 (stage I to III) colon carcinoma.
•Have indication for elective curative intended surgery without neoadjuvant chemo-therapy.
•Be = 18 years of age on the date of signing the informed consent.
•Provide written informed consent prior to registration according to the local regula-tory requirements.
•Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Have adequate bone marrow function:
•oHemoglobin = 6.2 mmol/L or = 10 g/dL
•oAbsolute neutrophil count (ANC) = 1.5 × 109/L
•oPlatelet count = 100 × 109/L
•Have adequate kidney function:
•oGlomerular filtration rate (GFR) = 60 mL/min or creatinine =1.5 X upper lim-it of normal (ULN)
•Have adequate liver function:
•oTotal bilirubin = 1.5 × ULN
•oAlanine aminotransferase (ALT): 10–70 U/L for males and 10–45 U/L for fe-males or = 2.5 × ULN
•oAlkaline phosphatase: 35–105 U/L or = 2.5 × ULN
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 42
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 43

•Has any serious or uncontrolled medical disorder that, in the opinion of the investi-gator or treating physician, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
•Has an autoimmune disorder (except thyroiditis with replacement therapy and type I diabetes mellitus).
•Has received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody/drug specifically targeting the T-cell co-stimulation or checkpoint pathways.
•Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active chronic or acute Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA is detected).
•Has a condition 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 autoim-mune disease.
•Has a history of allergy to study drug components or a history of severe hypersensi-tivity reaction to any monoclonal antibody

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