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

Titre officiel

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

Sommaire:

Il s’agit d’une étude de phase III, internationale, à répartition aléatoire et à double insu, contrôlée par placebo, visant à évaluer l’efficacité et l’innocuité d’un traitement adjuvant par atézolizumab par rapport à un placebo chez les participants atteints d’un cancer de la vessie à envahissement musculaire (CVEM) chez qui on détecte de l’ADN tumoral circulant (ADNtc) et qui présentent un risque élevé de récidive après une cystectomie.

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov