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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: Active Phase 3 study of Muscle-invasive Bladder Cancer, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
INV-DFS, defined as the time from randomization to the first occurrence of a DFS event, defined as any of the following: * Local (pelvic) recurrence of urothelial carcinoma (UC) (including soft tissue and regional lymph nodes); * Urinary tract recurrence of UC (including all pathological stages and grades); * Distant metastasis of UC; * Death from any cause.
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 |
What the registry record for NCT04660344 still lists
NCT04660344 is an interventional study that assigns participants to a tested intervention. The registered 761 participants enrollment target is mid-sized for trials with a published cap, below the 1,260-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (40% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Muscle-invasive Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04660344's enrollment target sits among peer trials
761 4th of 10 higher than 7 of 10 other Muscle-invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
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-
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Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma At High-Risk Recurrence
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RECRUITING
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