EUCTR2016-000202-11-IT进行中（未招募）1 期
A Phase III, open-label, multicenter, three-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab and atezolizumab monotherapy vs. regorafenib in patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma - A Phase III, open-label, multicenter, three-arm, randomized study to investigate the efficacy and sa
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 363
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
- •Disease specific inclusion criteria:
- •Histologically confirmed adenocarcinoma originating from the colon or
- •rectum (Stage IV American Joint Committee on Cancer 7th edition)
- •Experienced disease progression on at least two prior systemic
- •chemotherapy regimens for mCRC
- •1. Prior systemic cytotoxic chemotherapy must include ALL of the
- •following agents:
- •a) Fluoropyrimidines
- •b) Irinotecan
- •c) Oxaliplatin
- •2. Patients who have received prior anti-angiogenic therapy (e.g.,
- •bevacizumab) and/or anti epidermal growth factor receptor therapy
- •(e.g., cetuximab) are eligible.
- •3. Patients must have had documented disease progression within 3
- •months of the last systemic therapy administration.
- •4. Patients who were intolerant to prior systemic chemotherapy
- •regimens are eligible if there is documented evidence of clinically
- •significant intolerance despite adequate supportive measures.
- •5. For patients who had disease recurrence within 6 months of
- •completing adjuvant chemotherapy, the adjuvant regimen can be
- •considered as one chemotherapy regimen for metastatic disease.
- •General inclusion criteria:
- •Signed Informed Consent Form
- •Age = 18 years
- •In the investigator's judgment, patient is able to comply with the
- •requirements and assessments of the study protocol
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Anticipated life expectancy = 3 months
- •Able to comply with the requirements and assessments of the study
- •Adequate hematologic and end organ function, defined by the following
- •laboratory results obtained within 14 days prior to first dose of study
- •drug treatment:
- •1.Hemoglobin = 9 g/dL, platelet count = 100,000/mm3, ANC =
- •2.Creatinine clearance = 30 mL/min
- •3.Amylase and lipase = 1.5 x the upper limit of normal (ULN)
- •4.Serum bilirubin = 1.5x ULN; patients with known Gilbert's disease may
- •have a bilirubin = 3.0x ULN
- •5.AST, ALT, and alkaline phosphatase (ALP) = 2.5 ULN with the following
- •exceptions:
- •a)Patients with documented liver metastases: AST and/or ALT = 5 x ULN
- •b)Patients with documented liver or bone metastases: ALP = 5 x ULN
- •6.INR and PTT = 1.5 x 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 agree to appropriately use an
- •effective form of contraception (failure rate of < 1% per year) during the
- •treatment period, within 5 months after the last dose of atezolizumab, and within 3 months after the last dose of cobimetinib and regorafenib.
- •7.A woman of childbearing potential is defined as a sexually mature
- •woman without prior ophorectomy or hysterectomy who have had
- •menses within the last 12 months.
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排除标准
- •Cancer-related exclusion criteria:
- •After the approximate 5% cap for MSI-high patients is reached, only
- •MSI-stable patients will be eligible.
- •Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or
- •anticipation of needing such procedure while receiving study treatment.
- •Treatment with any anti-cancer agent within 14 days prior to Cycle 1
- •Uncontrolled tumor-related pain. Patients requiring narcotic pain
- •medication must be on a stable regimen at study entry.
- •Uncontrolled pleural effusion, pericardial effusion or ascites requiring
- •repeated drainage more than once every 28 days. Indwelling drainage
- •catheters (e.g., PleurX ) are allowed.
- •Active or untreated CNS metastases are excluded. Patients with
- •treated and asymptomatic CNS metastases are eligible,
- •Exclusion criteria related to study medication:
- •Any cancer immunotherapy including CD137 agonists, anti-programmed
- •death-1, anti PD L1, or anti CTLA4; Any MEK or ERK inhibitor; and
- •Regorafenib
- •Patients with active malignancy (other than CRC) or a prior malignancy
- •within the past 3 years are excluded. Patients with completely resected
- •cutaneous melanoma (early stage), basal cell carcinoma, cutaneous
- •squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma
- •in-situ, and localized prostate cancer are eligible.
- •Exclusion criteria based on organ function or medical history:
- •Cardiovascular:
- •Unstable angina, new onset angina within last 3 months, myocardial
- •infarction within last 6 months and current congestive heart failure New
- •York Heart Association Class II or higher.
- •Left ventricular ejection fraction below institutional lower limit of
- •normal or below 50%, whichever is lower.
- •Poorly controlled hypertension, defined as a blood pressure
- •consistently above 150/90 mmHg despite optimal medical management.
- •Infections:
- •HIV infection
- •Severe infections within 2 weeks prior to Cycle 1 Day 1
- •Signs or symptoms of significant infection within 2 weeks prior to Cycle
- •Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- •Active or chronic viral hepatitis B or C infection
- •History of or evidence of retinal pathology on ophthalmologic
- •examination that is considered a risk factor for central serous
- •retinopathy, retinal vein occlusion, or neovascular macular degeneration
- •Patients will be excluded if they currently have risk factors for retinal
- •vein occlusion
- •Autoimmune conditions and immunomodulatory drugs:
- •History of autoimmune disease
- •History of idiopathic pulmonary fibrosis, organizing pneumonia,
- •bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic
- •pneumonitis
- •Other medical conditions or medications:•Any hemorrhage or bleeding event CTCAE Grade 3 or higher within 28
- •days of Cycle 1 Day 1
- •Foods, supplements or drugs that are potent CYP3A4 enzyme inducer or
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