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NCT04543617 · ClinicalTrials.gov registry record · Phase 3

A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

A Phase 3 study of Esophageal Squamous Cell Carcinoma, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
760
Enrollment target
20
Study locations

NCT04543617 is a Phase 3 study of Esophageal Squamous Cell Carcinoma that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 760 participants, above the 346-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT04543617, a Phase 3 study of Esophageal Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
760 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).

Conditions Studied

Esophageal Squamous Cell Carcinoma

Interventions

  • DRUG Atezolizumab
  • DRUG Tiragolumab
  • DRUG Tiragolumab Matching Placebo
  • DRUG Atezolizumab Matching Placebo

Study Locations (20)

Other

  • Instituto de Investigaciones Metabolicas (Idim) - Buenos Aires
  • Fundacion Favaloro - Buenos Aires
  • Centro Oncologico Riojano Integral (CORI) - La Rioja
  • Tiroler Landeskrankenanstalten Ges.M.B.H. - Innsbruck
  • Klinikum Klagenfurt am Wörthersee - Klagenfurt
  • Ordensklinikum Linz Barmherzige Schwestern - Linz
  • AKH - Medizinische Universität Wien - Vienna
  • UZ Antwerpen - Edegem
  • UZ Leuven Gasthuisberg - Leuven
  • CHU de Liège (Sart Tilman) - Liège
  • Anyang Tumor Hosptial - Anyang
  • Cancer Hospital Chinese Academy of Medical Sciences. - Beijing
  • Affiliated Hospital of Bengbu Medical College - Bengbu
  • Hunan Cancer Hospital - Changsha

Florida

  • Florida Cancer Specialists - Fort Myers (Broadway) - Fort Myers

Kansas

  • Cancer Center of Kansas - Wichita

New York

  • Great Lakes Cancer Center - Williamsville

Queensland

  • Princess Alexandra Hospital - Woolloongabba

Victoria

  • Austin Health - Heidelberg

Western Australia

  • St John of God Hospital - Subiaco

Trial Details

FieldValue
Enrollment Target 760 participants
Start Date 2020-09-28
Est. Completion 2027-03-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04543617

The ClinicalTrials.gov registry entry for NCT04543617 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 760 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 346-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (120% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Esophageal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Atezolizumab is the first listed.

NCT04543617 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Florida, Kansas.

Frequently Asked Questions

What is clinical trial NCT04543617 about?

NCT04543617 is a clinical study titled "A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy". The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following defin...

What is the current status of trial NCT04543617?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 760 participants. The study started on 2020-09-28. Estimated completion is 2027-03-31.

What conditions does trial NCT04543617 study?

This clinical trial studies the following conditions: Esophageal Squamous Cell Carcinoma.

What interventions are being tested in trial NCT04543617?

The interventions under investigation include: Atezolizumab (DRUG), Tiragolumab (DRUG), Tiragolumab Matching Placebo (DRUG), Atezolizumab Matching Placebo (DRUG).

Who is sponsoring clinical trial NCT04543617?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04543617 being conducted?

This trial has 20 study locations across Florida, Kansas, New York, Queensland, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.