EUCTR2020-004418-36-DE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9日最近更新:
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
- •Inclusion criteria for the Surveillance Phase
- •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. Patients
- •with carcinomas showing mixed histology's are required to have a dominant transitional cell pattern.
- •TNM classification (based on American Joint Committee on Cancer
- •[AJCC] Cancer Staging Manual, 8th Edition) at pathological examination of surgical resection
- •– Patients who received, or did not receive, platinum-based NAC
- •with tumor stage of (y)pT2-4aN0M0 or (y)pT0-4aN + M0
- •o Patients who have received at least three cycles of a platinum-containing regimen will be considered as having received prior NAC.
- •Surgical resection of MIUC of the bladder
- •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
- •Submission of blood sample for plasma ctDNA testing, collected at
- •least 6 weeks post-surgery
- •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 28 days prior to enrollment
- •Full recovery from cystectomy and enrollment within 24 weeks following cystectomy (Minimum of 6 weeks must have elapsed from
- •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 out of the 16
- •mutations identified 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 28 days prior to randomization, as assessed by the investigator
- •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 >= 1.5 - 109/L (1500/L) without granulocyte colony-stimulating
- •factor support
- •–WBC counts > 2500/L
- •–Lymphocyte count >= 0.3 x 109/L (300/L)
- •–Platelet count >=100 x 109/L (100,000/L) 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
- •General Medical Exclusion Criteria for the Surveillance Phase
- •?Known PD-L1 IHC result for adjuvant therapy. The decision for the adjuvant therapy should not be based on the PD-L1 IHC result. If a cap is in effect limiting enrollment of PD-L1 negative patients, this exclusion criterion will not apply
- •?Pregnancy or breastfeeding
- •?Positive test for 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/µL, and
- •have an undetectable viral load
- •?Patients with active hepatitis B virus (HBV) or hepatitis C
- •-Patients with past HBV infection or resolved HBV infection are eligible.
- •A negative HBV DNA test must be obtained in these patients prior to enrollment.
- •?Patients positive for hepatitis C virus (HCV) antibody are eligible only if
- •polymerase chain reaction is negative for HCV RNA
- •?Active tuberculosis confirmed by a test performed within 3 months prior
- •to treatment initiation
- •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
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (bronchiolitis obliterans), drug-induced pneumonitis, idiopathic
- •pneumonitis, or evidence of active pneumonitis on screening chest CT
- •?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 Surveillance and the Treatment
- •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 halflives
- •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
研究者
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