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NCT04660344 · ClinicalTrials.gov registry record · Phase 3
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 3 study of Muscle-invasive Bladder Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 761
- Enrollment target
- 20
- Study locations
NCT04660344 is a Phase 3 study of Muscle-invasive Bladder Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 761 participants, below the 1,260-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT04660344, a Phase 3 study of Muscle-invasive Bladder Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 761 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Atezolizumab
- OTHER Placebo
- DEVICE Signatera
Study Locations (20)
Other
- Centro Medico Austral - Buenos Aires
- Instituto Alexander Fleming - Buenos Aires
- AZ KLINA - Brasschaat
- UZ Gent - Ghent
- AZ Delta (Campus Rumbeke) - Roeselare
Rio Grande do Sul
- Hospital Moinhos de Vento - Porto Alegre
- Hospital Sao Lucas - PUCRS - Porto Alegre
- Hospital Nossa Senhora da Conceicao - Porto Alegre
São Paulo
- *X*Fundação Pio XII Hospital de Câncer de Barretos - Barretos
- Hospital Amaral Carvalho - Jaú
California
- UCLA Department of Medicine - Santa Monica
Colorado
- Rocky Mountain Cancer Center - Denver - Littleton
Florida
- Cancer Care Centers of Brevard - Rockledge
Nevada
- Optum Health Care - Las Vegas
North Carolina
- Wake Forest Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 761 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2026-09-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04660344
The ClinicalTrials.gov registry entry for NCT04660344 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 761 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,260-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (40% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Muscle-invasive Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT04660344 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Rio Grande do Sul, São Paulo.
Frequently Asked Questions
What is clinical trial NCT04660344 about?
NCT04660344 is a clinical study titled "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". 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 f...
What is the current status of trial NCT04660344?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 761 participants. The study started on 2021-05-03. Estimated completion is 2026-09-13.
What conditions does trial NCT04660344 study?
This clinical trial studies the following conditions: Muscle-invasive Bladder Cancer.
What interventions are being tested in trial NCT04660344?
The interventions under investigation include: Atezolizumab (DRUG), Placebo (OTHER), Signatera (DEVICE).
Who is sponsoring clinical trial NCT04660344?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04660344 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Nevada, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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