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ACTIVE NOT RECRUITING 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

NCT04543617 · View on ClinicalTrials.gov ↗

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).

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

758 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. 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 760 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 Esophageal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 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: NCT04543617 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Florida, Kansas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04543617?

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 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.

Related

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