Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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

NCT04660344 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 761 participants
Start Date 2021-05-03
Est. Completion 2026-09-13
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 761 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04660344 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Rio Grande do Sul, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04660344?

The interventions under investigation include: Atezolizumab (DRUG), Placebo (OTHER), Signatera (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04660344?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial