High-risk muscle-invasive bladder cancer
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Investigator assessed DFS in patients who are ctDNA-positive within 24 weeks of cystectomy (primary analysis population) | — |
Secondary
| Measure | Time 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