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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2026-04-17

No results posted yet for this 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

Interventions

DRUG

Tiragolumab

Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

DRUG

Atezolizumab

Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

DRUG

Tiragolumab Matching Placebo

Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

DRUG

Atezolizumab Matching Placebo

Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Kenya
  • Morocco
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04543617 on ClinicalTrials.gov