EUCTR2019-001501-24-IT进行中（未招募）1 期
PHASE II STUDY OF AVELUMAB AND CETUXIMAB AND MODIFIED FOLFOXIRI AS INITIAL THERAPY FOR RAS WILD-TYPE UNRESECTABLE METASTATIC COLORECTAL CANCER PATIENTS - AVETRIC
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 个研究点目标入组 58 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically proven diagnosis of colorectal adenocarcinoma;
- •Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
- •At least one measurable lesion according to RECIST 1.1.;
- •Availability of a tumour tissue sample (primary tumour and/or metastatic sites);
- •Male or female of 18-75 years of age;
- •ECOG PS =2 for patients aged =70 years; ECOG PS 0 for patients aged 71 to 75 years;
- •Life expectancy of at least 12 weeks;
- •Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse;
- •RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) wild-type status of primary colorectal cancer or related metastasis (local or central laboratory assessment);
- •Adequate haematological function: neutrophils >1.5 x 109/L, platelets >100 x 109/L, haemoglobin >9 g/dl;
- •Adequate liver and renal function: total bilirubin 1.5 time the upper-normal limits (UNL) of the normal values and AST (SGOT) and/or ALT (SGPT) <2.5 x UNL (or <5 x UNL in case of liver metastases) alkaline phosphatase <2.5 x UNL (or <5 x UNL in case of liver metastases); creatinine clearance =50 mL/min or serum creatinine 1.5 x UNL;
- •INR or aPTT =1.5 × ULN. Patients who are on therapeutic doses of anti-coagulants are eligible if they are on a stable dose of anti-coagulant for 28 days with stable INR and PTT values;
- •Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 continuous months, are surgically sterile, or are sexually inactive;
- •Subjects and their partners must be willing to avoid pregnancy during the trial and until 6 months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator (barriere contraceptive measure or oral contraception);
- •Will and ability to comply with the protocol;
- •Written informed consent to study procedures and to molecular analyses.
- •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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Radiotherapy to any site within 4 weeks before the study;
- •Previous adjuvant oxaliplatin-containing chemotherapy;
- •Previous treatment with cetuximab;
- •Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents;
- •Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer);
- •Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the trial treatment and/or if the subject has not fully recovered from the surgery within
- •4 weeks of the trial treatment, or anticipation of the need for major surgical procedure during the course of the study;
- •Subjects receiving immunosuppressive agents for any reason should be tapered off these drugs before initiation of the trial treatment
- •All subjects with brain metastases;
- •Symptomatic peripheral neuropathy > 2 grade NCI-CTCAE v5.0;
- •Other co-existing malignancies or previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ;
- •Prior organ transplantation;
- •Significant acute or chronic infections;
- •Active autoimmune disease;
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis on screening chest CT scan;
- •Known prior severe hypersensitivity to investigational product or any component in its formulations;
- •Pregnant or lactating women.
- •Known alcohol or drug abuse;
- •History of uncontrolled intercurrent illness included but not limited to:
- •a.Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower);
- •b.or, uncontrolled active infection requiring antibiotics at the time of initiation of study treatment.
- •Clinically significant cardiovascular disease
- •Uncontrolled coagulopathy;
- •Lack of upper gastrointestinal tract integrity or malabsorption syndrome; active inflammatory bowel disease;
- •All other significant disease which, in the opinion of the Investigator, might impair the subject’s tolerance of trial treatment;
- •Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements;
- •Administration of a live, attenuated vaccine within 4 weeks prior to start of study treatment or anticipation that such a live attenuated vaccine will be required during the study. Note: administration of inactivated vaccines is allowed (for example, inactivated influenza vaccines);
- •Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor [TNF] agents) within 2 weeks prior to start of study treatment, or requirement for systemic immunosuppressive medications during the trial. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed;
- •Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to start of study treatment;
- •Legal incapacity or limited legal capacity.
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