Randomized phase II study of FOLFOXIRI plus BEVACIZUMAB plus ATEZOLIZUMAB versus FOLFOXIRI plus BEVACIZUMAB as first-line treatment of unresectable metastatic colorectal cancer patients - AtezoTRIBE

G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 个研究点目标入组 201 人开始时间: 2021年6月18日最近更新: 2021年8月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 201

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•Written informed consent to study procedures and to molecular analyses
•Histologically proven diagnosis of colorectal cancer
•Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease
•At least one measurable lesion according to RECIST1.1 criteria
•Availability of a tumoral sample
•Male or female of 18-75 years of age
•ECOG PS < or = 2 if aged < 71 years, ECOG PS = 0 if aged 71-75 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
•Neutrophils > 1.5 x 109/L, Platelets >100 x 109/L, Hgb >9 g/dl
•Total bilirubin 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (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 1.25 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.
•Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate ¿1 g of protein/24 hr
•Male subjects with female partners of childbearing potential must be willing to use adequate contraception as outlined in Section 5.5 – Contraception, starting with the first dose of study therapy through 6 months after the last dose of bevacizumab and within 5 months after the last dose of atezolizumab.
•Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
•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.
•Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.5 – Contraception, for the course of the study starting with the first dose of study therapy through 6 months after the last dose of bevacizumab and within 5 months after the last dose of atezolizumab.
•Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
•Will and ability to comply with the protocol
•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 134
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 67

排除标准

•Clinically significant cardiovascular disease
•Previous treatment with bevacizumab
•Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
•Untreated brain metastases or spinal cord compression or primary brain tumours
•Pregnant or lactating women
•History of autoimmune disease
•History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis on screening chest CT scan
•Positive test for HIV
•Active HBV test or HCV
•Active tuberculosis
•Prior allogenic bone marrow transplantation or solid organ transplant
•Treatment with systemic corticosteroids or other systemic immunosuppressive medications
•Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of the atezolizumab formulation
•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
•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
•If receiving a RANKL inhibitor (e.g. denosumab), unwilling to adopt alternative treatment such as (but not limited to) bisphosphonates, while receiving atezolizumab.

研究者

发起方

G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST

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