Last updated 2 months ago
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy
800 patients around the world
Available in Argentina, United States, Brazil, Spain
Hoffmann-La Roche
19Research sites
800Patients around the world
This study is for people with
Bladder Cancer
Muscle-Invasive Bladder Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically confirmed MIUC (also termed TCC) of the bladderTNM classification (based on AJCC Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: 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 M0Surgical resection of MIUC of the bladderPatients who have received prior platinum-based NAC.Patients who have not received prior platinum-based NAC, have refused, or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy.ctDNA assay developed based on tumor tissue specimen and matched normal DNA from 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 24 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery.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) reportAbsence 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 investigatorECOG Performance Status of <= 2Life expectancy >=12 weeksAdequate hematologic and end-organ function, investigator decisionFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
- 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 breastfeedingPositive 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 loadPatients with active hepatitis B virus 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 proteinsKnown hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulationHistory of autoimmune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be 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, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.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 anginaAny approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollmentAdjuvant chemotherapy or radiation therapy for UC following cystectomyTreatment 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 enrollmentMalignancies other than UC within 5 years prior to study enrollmentAny approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to randomization to the treatment phase Hormone-replacement therapy or oral contraceptives are allowed.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 randomization to the treatment phasePatients with active hepatitis B virus or hepatitis CActive tuberculosis confirmed by a test performed within 3 months prior to treatment initiation
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Centro Médico Austral OMI - CABA
Recruiting
Hospital Erasto Gaertner
Recruiting
CETUS Hospital Dia Oncologia - Belo Horizonte
Recruiting
Clínica Viver - Santa Maria
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
Beneficência Portuguesa de São Paulo
Recruiting
Hospital Moinhos de Vento
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
StudyIMvigor011
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Muscle-Invasive Bladder Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04660344
