A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

Official Title

A Phase III, Open-Label, Multicentre, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

Summary:

This Phase III, open-label, randomized, multicentre study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants will be randomized by a 1:1 ratio into atezolizumab group or control group.

Trial Description

Primary Outcome:

  • Disease-Free Survival (DFS), as Assessed by Investigator
Secondary Outcome:
  • Overall Survival (OS)
  • Disease-Specific Survival (DSS), as Assessed by Investigator
  • Distant Metastasis-Free Survival (DMFS)
  • Non-Urinary Tract Recurrence-Free Survival (NURFS)
  • Percentage of Participants with Adverse Events (AEs)
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
  • European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score
  • Minimum Observed Serum Atezolizumab Concentration (Cmin)
  • Maximum Observed Serum Atezolizumab Concentration (Cmax)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society