A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

Official Title

A Phase III, Double-Blind, Multicentre, 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

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 ctDNA positive and are at high risk for recurrence following cystectomy.

Trial Description

Primary Outcome:

• IRF-assessed DFS in Participants Who Are ctDNA Positive Within 20 Weeks of Cystectomy

• Overall survival (OS) in Participants Who Are ctDNA Positive Within 20 weeks After Cystectomy
• IRF-assessed DFS in All Randomized Participants
• Investigator-Assessed DFS in Primary Analysis Population
• Investigator-Assessed DFS in All Randomized Participants
• Investigator-Assessed Disease-Specific Survival in Primary Analysis Population
• Investigator-Assessed Distant Metastasis-Free Survival in Primary Analysis Population
• Time to Deterioration of Function and Quality of Life (QoL) in Primary Analysis Population and in All Randomized Population
• ctDNA Clearance in Primary Analysis Population
• Percentage of Participants With Adverse Events
• Serum Concentration of Atezolizumab
• Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab
• Prevalence of ADAs to Atezolizumab

View this trial on ClinicalTrials.gov