EUCTR2014-005603-25-BE进行中（未招募）1 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) VERSUS OBSERVATION AS ADJUVANT THERAPY IN PATIENTS WITH HIGH RISK MUSCLE INVASIVE UROTHELIAL CARCINOMA AFTER SURGICAL RESECTIO
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
- 800
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
- •- Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
- •- Patients with upper urinary tract urothelial carcinoma (UTUC) will be limited to no more than approximately 10% of the study population
- •- Tumor Nodes Metastasis (TNM) classification at pathological examination of surgical resection- For patients treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for patients with UTUC); For patients not treated with prior neoadjuvant chemotherapy: tumor stage of pT3-T4a or pN+ (pT3-4 or pN+ for patients with UTUC)
- •- Surgical resection of muscle-invasive UC of the bladder, or upper urinary tract
- •- Muscle-invasive UC with programmed death ligand 1 (PD-L1) expression per immunohistochemistry (IHC) prospectively determined on the surgical resection or lymph node dissection tumor specimens by a central laboratory
- •- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 6 weeks prior to randomization
- •- Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
- •- Eastern Cooperative Oncology Group performance status score of <=2
- •- Life expectancy >=12 weeks
- •- Adequate hematologic and end-organ function
- •- For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, and agreement to refrain from donating eggs during this
- •same period
- •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 352
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 448
排除标准
- •- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- •- Adjuvant chemotherapy or radiation therapy for UC following surgical resection
- •- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •- Malignancies other than UC within 5 years prior to Cycle 1, Day 1
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •- History of autoimmune disease
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •- Tested Positive for HIV
- •- Patients with active hepatitis B virus and tuberculosis
- •- Prior allogeneic stem cell or solid organ transplant
- •- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
- •- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
研究者
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