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A 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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502052-30-00
Acronym
YO42137
Enrollment
167
Registered
2024-07-19
Start date
2020-10-27
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Esophageal Squamous Cell Carcinoma

Brief summary

1. Progression-Free Survival as determined by the investigator (for tiragolumab + atezolizumab compared with double placebo), 2. Overall survival (for tiragolumab + atezolizumab compared with double placebo), 3. Overall Survival (for placebo + atezolizumab compared with double placebo)

Detailed description

1. Progression-Free Survival as determined by the investigator (for placebo + atezolizumab compared with double placebo), 2. Progression-Free Survival as determined by the investigator (for tiragolumab + atezolizumab compared with placebo + atezolizumab), 3. Overall Survival (for tiragolumab + atezolizumab compared with placebo + atezolizumab), 4. Progression-Free Survival as determined by the independent review facility (IRF) (for tiragolumab + atezolizumab compared with placebo + atezolizumab and double placebo), 5. Confirmed ORR as determined by the investigator (for tiragolumab + atezolizumab compared with placebo + atezolizumab and double placebo), 6. Confirmed ORR as determined by an IRF, 7. Duration of response as determined by the investigator, 8. Duration of response as determined by the IRF, 9. Proportion of patients with clinically meaningful changes in physical functioning, role functioning, global health status/quality of life, and dysphagia, as measured by the respective scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire and the European Organisation for Research and Treatment of Cancer Quality of Life-Esophageal Cancer, Module 18 Questionnaire, 10. Incidence and severity of adverse events, 11. Severity for all events will be graded according to NCI CTCAE v5.0, and severity for CRS will also be graded according to the ASTCT consensus grading scale., 12. Serum concentration of tiragolumab and atezolizumab at specified timepoints, 13. Prevalence of anti-drug antibody (ADAs) to tiragolumab at baseline and incidence of ADAs to tiragolumab during the study, 14. Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGTiragolumab

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Progression-Free Survival as determined by the investigator (for tiragolumab + atezolizumab compared with double placebo), 2. Overall survival (for tiragolumab + atezolizumab compared with double placebo), 3. Overall Survival (for placebo + atezolizumab compared with double placebo)

Secondary

MeasureTime frame
1. Progression-Free Survival as determined by the investigator (for placebo + atezolizumab compared with double placebo), 2. Progression-Free Survival as determined by the investigator (for tiragolumab + atezolizumab compared with placebo + atezolizumab), 3. Overall Survival (for tiragolumab + atezolizumab compared with placebo + atezolizumab), 4. Progression-Free Survival as determined by the independent review facility (IRF) (for tiragolumab + atezolizumab compared with placebo + atezolizumab and double placebo), 5. Confirmed ORR as determined by the investigator (for tiragolumab + atezolizumab compared with placebo + atezolizumab and double placebo), 6. Confirmed ORR as determined by an IRF, 7. Duration of response as determined by the investigator, 8. Duration of response as determined by the IRF, 9. Proportion of patients with clinically meaningful changes in physical functioning, role functioning, global health status/quality of life, and dysphagia, as measured by the respective

Countries

Austria, Belgium, France, Germany, Greece, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026