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Clinical Trials in China / NCT04660344
Active, not recruiting Phase 3

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy

NCT04660344 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2021-05-03
Last updated
2026-03-27

Condition(s) studied

Muscle-invasive Bladder Cancer

Investigational drug(s) / intervention(s)

Atezolizumab →PlaceboSignatera

Atezolizumab: ctDNA positive participants will receive 1680 mg IV, every 4 weeks (Q4W) on Day 1 of each 28-day cycle.

Placebo: ctDNA positive participants will receive placebo IV, Q4W on Day 1 of each 28-day cycle

Signatera: Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up.

Study summary

This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Inclusion Criteria for the Surveillance Phase: * Histologically confirmed MIUC (also termed transitional cell carcinoma \[TCC\]) of the bladder * Tumor, nodes, and metastases (TNM) classification (based on American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: For participants treated with prior neoadjuvant chemotherapy (NAC): tumor stage of ypT2-4a or ypN+ and M0. For participants who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0 * Surgical resection of MIUC of the bladder * Participants who have not received prior platinum-based NAC must be ineligible for cisplatin-based adjuvant chemotherapy, have refused it, or will not receive it based on physician's decision * ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood * Tumor programmed death ligand (PD-L1) expression per immunohistochemistry (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 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 participant' whole exome sequencing (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 and Independent Review Facility * Eastern cooperative oncology group (ECOG) performance status of ≤ 2 * Life expectancy ≥12 weeks * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs Exclusion Criteria: 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 * Pregnancy or breastfeeding * Positive test for human immunodeficiency virus (HIV), with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a cluster of differentiation 4 (CD4) count ≥ 200 per microliter (/µL), and have an undetectable viral load * Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV). Participants with past HBV infection or resolved HBV infection are eligible. A negative HBV deoxyribonucleic acid (DNA) test must be obtained in these participants prior to enrollment. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA * Active tuberculosis (TB) 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. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Participants with controlled type I diabetes mellitus (T1DM) 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 (MI) within the previous 3 months, unstable arrhythmias, or unstable angina Cancer-Specific Exclusion Criteria for the Surveillance Phase: * Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollment * Adjuvant chemotherapy or radiation therapy for 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 * Malignancies other than UC within 5 years prior to study enrollment Additional Exclusion Criteria for the Treatment Phase: * Any 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 * Adjuvant chemotherapy or radiation therapy for 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 randomization to the treatment phase * Positive test for HIV, with the following exception: Participants 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 * Participants with active HBV or HCV * Active tuberculosis confirmed by a test performed within 3 months prior to treatment initiation

Primary outcome measure(s)

Trial sites (148)

FacilityCityRegionStatus
Cancer Care Centers of Brevard Rockledge Florida
Optum Health Care Las Vegas Nevada
Cleveland Clinic Cleveland Ohio
AHN Cancer Institute ? Allegheny General Hospital Pittsburgh Pennsylvania
Centro Medico Austral Buenos Aires Argentina
Instituto Alexander Fleming Buenos Aires Argentina
AZ KLINA Brasschaat Belgium
UZ Gent Ghent Belgium
Oncocentro Serviços Medicos E Hospitalares Ltda Fortaleza Ceará
CETUS Hospital Dia Oncologia Belo Horizonte Minas Gerais
Hospital Erasto Gaertner Curitiba Paraná
Hospital Moinhos de Vento Porto Alegre Rio Grande do Sul
Hospital Sao Lucas - PUCRS Porto Alegre Rio Grande do Sul
Hospital Nossa Senhora da Conceicao Porto Alegre Rio Grande do Sul
*X*Fundação Pio XII Hospital de Câncer de Barretos Barretos São Paulo
Hospital Amaral Carvalho Jaú São Paulo
Instituto do Cancer do Estado de Sao Paulo - ICESP São Paulo São Paulo
Hospital Alemao Oswaldo Cruz São Paulo São Paulo
Friendship Hospital, Capital Medical University Beijing China
the First Hospital of Jilin University Changchun China
Hu Nan Provincial Cancer Hospital Changsha China
Chongqing Cancer Hospital Chongqing China
The First Affiliated Hospital of Fujian Medical University Fuzhou China
The First Affiliated Hospital of Guangzhou Medical University Guangzhou China
Jiangsu Cancer Hospital Nanjing China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) Nanjing China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing China
Zhongshan Hospital Fudan University Shanghai China
Fudan University Shanghai Cancer Center Shanghai China
Tianjin Cancer Hospital Tianjin China
Yantai Yu Huangding Hospital Yantai China
Clinica del Country Bogotá Colombia
Instituto Cancerología Medellin Medellín Colombia
Oncomedica S.A. Montería Colombia
Fakultni nemocnice Olomouc Olomouc Czechia
Fakultni nemocnice v Motole Prague Czechia
Fakultni Thomayerova nemocnice Praha 4 - Krc Czechia
ICO Paul Papin Angers France
Institut Sainte Catherine Avignon France
Hopital Saint Andre Bordeaux France

+ 108 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Hoffmann-La Roche trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04660344 on ClinicalTrials.gov ↗ ← All trials in China