Trials / Active Not Recruiting
Active Not RecruitingNCT04660344
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 761 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | ctDNA positive participants will receive 1680 mg IV, every 4 weeks (Q4W) on Day 1 of each 28-day cycle. |
| OTHER | Placebo | ctDNA positive participants will receive placebo IV, Q4W on Day 1 of each 28-day cycle |
| DEVICE | Signatera | Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. |
Timeline
- Start date
- 2021-05-03
- Primary completion
- 2025-06-15
- Completion
- 2026-10-01
- First posted
- 2020-12-09
- Last updated
- 2026-03-27
Locations
148 sites across 24 countries: United States, Argentina, Belgium, Brazil, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Poland, Russia, Singapore, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04660344. Inclusion in this directory is not an endorsement.