EUCTR2020-004418-36-GR进行中（未招募）1 期
A PHASE III, DOUBLE-BLIND, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) VERSUS PLACEBO ASADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE BLADDER CANCER WHO ARE CTDNA-POSITIVE FOLLOWING CYSTECTOMY
F. Hoffman-La Roche Ltd.0 个研究点目标入组 495 人开始时间: 2021年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 495
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 at time of signing Informed Consent Form
- •Histologically confirmed muscle-invasive urothelial carcinoma (MIUC) (also termed transitional cell carcinoma [TCC]) of the bladder
- •TNM classification (based on American Joint Committee on Cancer [AJCC] Cancer Staging Manual, 7th Edition) at pathological examination of surgical resection
- •– For patients treated with prior NAC: tumor stage of ypT2-4a or ypN+ and M0
- •– For patients who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0
- •Surgical resection of MIUC of the bladder
- •Patients who have not received prior platinum-based neoadjuvant chemotherapy (NAC), have refused, or are ineligible (unfit”) for cisplatin-based adjuvant chemotherapy
- •pT2N0 patients who have not received prior platinum-based NAC regardless of cisplatin ineligibility are eligible.
- •Availability of a surgical tumor specimen that is suitable (adequate quality and quantity) for use in determining PD L1 expression, WES evaluable (ctDNA assay designability) report, and for exploratory biomarker research assessed by central laboratory testing
- •Submission of a post-surgery matched blood sample for the identification of somatic mutations in tumor tissue
- •Availability of a WES-evaluable (ctDNA assay designablility) report that is based on tumor tissue specimen and matched blood
- •Tumor PD-L1 expression per IHC that is evaluable by central testing of a representative tumor tissue specimen
- •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 4 weeks prior to enrollment
- •Full recovery from cystectomy and enrollment within 14 weeks following cystectomy (Minimum of 6 weeks must have elapsed from surgery)
- •Additional Inclusion Criteria for the Treatment Phase
- •Blood for plasma ctDNA sample evaluated to be ctDNA-positive, defined as the presence of two or more mutations based on patient’s WES evaluable (ctDNA assay designability) report
- •Absence of residual disease and absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of <=2
- •Life expectancy >=12 weeks
- •Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- •– ANC >= 1.5x10^9/L (1500/uL) without granulocyte colony stimulating factor support
- •– WBC counts >2500/uL
- •– Lymphocyte count >= 0.3x10^9/L (300/uL)
- •– Platelet count >=100x10^9/L (100,000/uL) without transfusion
- •– Hemoglobin >= 90 g/L (9 g/dL)
- •Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception with a failure rate of <1% per year and agreement to refrain from donating eggs during the treatment period and for 5 months after the final dose of atezolizumab.
- •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 198
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 297
排除标准
- •Pregnancy or breastfeeding
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- •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
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •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
- •Prior allogeneic stem cell or solid organ transplant
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the patient at high risk from treatment complications
- •Additional Exclusion Criteria for the Treatment Phase
- •Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollment or randomization to the treatment phase
- •Adjuvant chemotherapy or radiation therapy for urothelial carcinoma (UC) following cystectomy
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to enrollment or randomization to the treatment phase
- •Malignancies other than UC within 5 years prior to study enrollment
- •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
- •Receipt of therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to Cycle 1, Day 1
- •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
- •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
- •Serum albumin <2.5 grams per deciliter (g/dL)
- •Positive test for human immunodeficiency virus (HIV), with the following exception:
- •- Patients with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a CD4 count >= 200/uL, and have an undetectable viral load.
- •Patients with active hepatitis B virus or hepatitis C
- •Active tuberculosis
- •Additional Medication-Related Exclusion Criteria for the Treatment Phase:
- •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
- •Treatment with systemic immunostimulatory agents (including, but not limited to, IFNs, IL-2) within 4 weeks or 5
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