EUCTR2016-004165-58-BE进行中（未招募）1 期
A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF MOXR0916 IN COMBINATION WITHATEZOLIZUMAB VERSUS ATEZOLIZUMAB ALONE IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE INELIGIBLE FOR CISPLATIN-BASED THERAPY
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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
- •- Age >= 18 years
- •- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2
- •- Life expectancy >= 12 weeks
- •- Histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC)
- •- Availability of a representative tumor specimen to enable central testing for determination of PD-L1 status and exploratory research on biomarkers
- •- No prior systemic therapy for inoperable locally advanced or metastatic UC
- •- Ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria:
- •Impaired renal function (glomerular filtration rate [GFR] > 30 but < 60 mililitre/minute); National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 Grade >= 2 audiometric hearing loss (25 Decibel at two contiguous frequencies or more severe);
- •NCI CTCAE v 4.0 Grade >= 2 peripheral neuropathy;
- •ECOG Performance Status of 2
- •- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1
- •- Adequate hematologic and end-organ function
- •- For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of study treatment
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- •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 187
排除标准
- •- Pregnant or lactating, or intending to become pregnant or breast feed during the study or 6 months afterward
- •- Significant cardiovascular disease, such as New York Heart Association cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- •- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease
- •- Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
- •- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug
- •- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment except palliative radiotherapy for bone metastases or soft tissue lesions that is completed > 7 days prior to baseline imaging; radiotherapy for brain metastases; prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment; hormone-replacement therapy or oral contraceptives; patients should be recovered from any toxicities associated with permitted anti-cancer therapies
- •- Prior treatment with CD137 or OX40 agonists, anti- cytotoxic T-lymphocyte-associated protein (CTLA4), anti-PD-1, anti-PD-L1, anti-CD-27, anti- Glucocorticoid-induced tumor necrosis factor receptor (GITR) therapeutic antibody or pathway-targeting agents
- •- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to initiation of study treatment
- •- Untreated central nervous system (CNS) metastases or active (progressing or requiring corticosteroids for symptomatic control) CNS metastases
- •- Any history of leptomeningeal disease
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •- Uncontrolled tumor-related pain
- •- Malignancies other than UC within 5 years prior to Cycle 1, Day 1
- •- Uncontrolled or symptomatic hypercalcemia
- •- History of autoimmune disease
- •- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
- •- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment
- •- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan
- •- Active hepatitis B and C virus infection
- •- Positive HIV test at screening
- •- Active tuberculosis
- •- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Treatment with a live, attenuated vaccine within 4 weeks before initiation of study treatment, or anticipation of need for such a vaccine during the course of the study
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or
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