Suspended

SKYSCRAPER-07Tiragolumab and Atezolizumab for Unresectable Esophageal Squamous Cell Carcinoma Post-Chemoradiotherapy

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What is being tested

Tiragolumab

+ Atezolizumab

+ Tiragolumab Matching Placebo

Drug
Who is being recruted

Esophageal Squamous Cell Carcinoma+12

+ Carcinoma

+ Carcinoma, Squamous Cell

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: September 2020
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 28, 2020

Actual date on which the first participant was enrolled.

This is a treatment study focusing on individuals with a type of esophageal cancer called squamous cell carcinoma that cannot be removed by surgery, or those who are unable or unwilling to undergo surgery. The cancer in these individuals has not worsened after undergoing a specific treatment called definitive concurrent chemoradiotherapy (dCRT). The main goal of this study is to evaluate the effectiveness and safety of using a combination of two drugs, tiragolumab and atezolizumab, compared to a placebo. This research is important as it aims to find a better treatment option for this type of cancer, potentially improving patient care and outcomes. Participants in this study are randomly assigned to one of three groups. The first group receives both tiragolumab and atezolizumab, the second group receives a placebo that matches tiragolumab and atezolizumab, and the third group receives a double placebo. The study measures the effects of these treatments by looking at how long participants live without their cancer getting worse (progression-free survival), and how long participants live overall (overall survival). These measurements help researchers understand the potential benefits and risks of the treatment.

Official TitleA Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
NCT04543617
Principal SponsorHoffmann-La Roche
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

760 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Esophageal Squamous Cell CarcinomaCarcinomaCarcinoma, Squamous CellDigestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesEsophageal NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNeoplasms, Squamous Cell

Criteria

7 exclusion criteria prevent from participating
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
Prior allogeneic stem cell or solid organ transplantation
Active or history of autoimmune disease or immune deficiency
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive atezolizumab followed by tiragolumab.

Group II

Experimental
Participants will receive atezolizumab followed by tiragolumab matching placebo.

Group III

Placebo
Participants will receive matching placebos to tiragolumab and atezolizumab.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 165 locations

Suspended

UZ Antwerpen

Edegem, BelgiumOpen UZ Antwerpen in Google Maps
Suspended

UZ Leuven Gasthuisberg

Leuven, Belgium
Suspended

CHU de Liège (Sart Tilman)

Liège, Belgium
Suspended

Anyang Tumor Hosptial

Anyang, China
Suspended165 Study Centers