EUCTR2014-004684-20-DE进行中（未招募）1 期
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF Atezolizumab (Anti-PD-L1 ANTIBODY) IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL CARCINOMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 915
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
- •- Unresectable advanced or metastatic RCC with clear-cell histology and/or component of sarcomatoid carcinoma
- •- Measurable disease, as defined by RECIST v1.1 - Karnofsky performance status >= 70
- •- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 28 calendar days prior to randomization: ANC >= 1500 cells/µL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1) WBC counts >= 2500/µL Lymphocyte count >= 300/µL Platelet count >= 100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1) Hemoglobin >=9.0 g/dL AST, ALT, and alkaline phosphatase =< 2.5 × the upper limit of normal (ULN), with the following exceptions: Patients with documented liver metastases: AST and ALT =<5 × ULN Patients with documented liver or bone metastases: alkaline phosphatase =< 5 × ULN
- •Serum bilirubin =<1.5 × ULN
- •Patients with known Gilbert disease who have serum bilirubin level =<3 × ULN may be enrolled.
- •INR and aPTT =<1.5 × ULN, unless on a stable dose of warfarin Serum albumin > 2.5 g/dL Creatinine clearance >= 30 mL/min (Cockcroft-Gault formula or based on 24 hour urine collection)
- •- Patients with a history of treated asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria:
- •Evaluable or measurable disease outside the CNS
- •Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord)
- •No history of intracranial or spinal cord hemorrhage
- •No evidence of significant vasogenic edema
- •No ongoing requirement for corticosteroids as therapy for CNS disease No stereotactic radiation within 14 days
- •No evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases.
- •Following treatment, these patients may then be eligible without the need for an additional brain scan prior to enrollment [or randomization], if all other criteria are met.
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of atezolizumab and bevacizumab or 30 days after the last dose of sunitinib
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures that result in a failure rate of < 1% per year, and agreement to refrain from donating sperm, for at least 6 months after the last dose of atezolizumab or bevacizumab or 30 days after the last dose of sunitinib
- •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 581
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 249
排除标准
- •Prior treatment with active or experimental systemic agents for treatment of RCC, including treatment in the neoadjuvant or adjuvant setting. Prior treatment with placebo in adjuvant setting is allowed.
- •Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments
- •Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated at least 14 days prior to Cycle 1, Day 1.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •Uncontrolled hypercalcemia (? 1.5 mmol/L ionized calcium or Ca ? 12 mg/dL or corrected serum calcium greater than the upper limit of normal]) or symptomatic hypercalcemia refractory to bisphosphonate therapy or denosumab
- •Pregnant and lactating , or intending to become pregnant during the study
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Malignancies other than RCC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent). Contact the Medical Monitor if there are concerns or if clarification is needed.
- •History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see the protocol for a more comprehensive list of autoimmune diseases) Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study.
- •Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or Patients with active hepatitis C
- •Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
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