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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

A Phase III, Double-blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-risk Muscle-invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

NCT04660344•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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
+4 more criteria

Exclusion Criteria

•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
+10 more criteria

Locations (161)

UCLA Department of Medicine

Santa Monica, California, United States

Rocky Mountain Cancer Center - Denver

Littleton, Colorado, United States

Cancer Care Centers of Brevard

Rockledge, Florida, United States

Optum Health Care

Las Vegas, Nevada, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

AHN Cancer Institute ? Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Centro Medico Austral

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

AZ KLINA

Brasschaat, Belgium

Key Dates

Start Date

May 3, 2021

Primary Completion Date

June 15, 2025

Completion Date

September 13, 2026

Last Updated

February 13, 2026

Enrollment

761

ACTUAL participants

Conditions

Muscle-invasive Bladder Cancer

Interventions

Atezolizumab

DRUG

Placebo

OTHER

Signatera

DEVICE

Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

NCT06567743

High-Risk Non-Muscle-Invasive Bladder Cancer

View study

RECRUITINGNA

Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study

NCT07339761

Bladder CancerNon-Muscle-Invasive Bladder Cancer (NMIBC)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study

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