Skip to content

A Phase III, Double-blind, Multicenter, Randomized study of Atezolizumab (anti-PD‑L1 antibody) versus Placebo as Adjuvant therapy in Patients with High-Risk Muscle-Invasive Bladder Cancer who are CTDNA positive following cystectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502705-15-00
Acronym
BO42843
Enrollment
112
Registered
2024-02-07
Start date
2021-03-08
Completion date
Unknown
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk muscle-invasive bladder cancer

Brief summary

1.Investigator assessed DFS in patients who are ctDNA-positive within 24 weeks of cystectomy (primary analysis population)

Detailed description

1. OS in patients who are ctDNA-positive within 24 weeks after cystectomy (primary analysis population), 2. Investigator-assessed DFS in in patients who are ctDNA-positive at any time following cystectomy (all-randomized population), 3. IRF- assessed DFS in the primary analysis population, 4. IRF- assessed DFS in all-randomized patients, 5. Investigator-assessed DSS in the primary analysis population, 6. Investigator-assessed DMFS in the primary analysis population, 7. Time to deterioration of function and QoL in the primary analysis population and in the all-randomized population, 8. ctDNA clearance in the primary analysis population, 9. Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 10. Change from baseline in targeted vital signs, 11. Change from baseline in targeted clinical laboratory test results, 12. Serum concentration of atezolizumab at specified timepoints, 13. Incidence of anti-drug antibodies (ADAs) to atezolizumab during the study, 14. Prevalence of ADAs to atezolizumab at baseline

Interventions

DRUGTecentriq concentrate for solution for infusion placebo 0mg

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1.Investigator assessed DFS in patients who are ctDNA-positive within 24 weeks of cystectomy (primary analysis population)

Secondary

MeasureTime frame
1. OS in patients who are ctDNA-positive within 24 weeks after cystectomy (primary analysis population), 2. Investigator-assessed DFS in in patients who are ctDNA-positive at any time following cystectomy (all-randomized population), 3. IRF- assessed DFS in the primary analysis population, 4. IRF- assessed DFS in all-randomized patients, 5. Investigator-assessed DSS in the primary analysis population, 6. Investigator-assessed DMFS in the primary analysis population, 7. Time to deterioration of function and QoL in the primary analysis population and in the all-randomized population, 8. ctDNA clearance in the primary analysis population, 9. Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 10. Change from baseline in targeted vital signs, 11. Change from baseline in targeted clinical laboratory test results, 12. Serum concentration of atezolizumab at

Countries

Belgium, Czechia, France, Germany, Greece, Ireland, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026