A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy (IMvigor011)
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy (IMvigor011)
ClinicalTrials.gov ID: NCT04660344
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2024-10-15
Brief 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.
Official Title:
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
Intervention / Treatment:
- Drug: Atezolizumab
- Other: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-05-03 |
| Primary Completion (Estimated) | 2025-04-30 |
| Study Completion (Estimated) | 2026-07-29 |
| Enrollment (Estimated) | 800 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
BO42843
|