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

Official record

Identifier

NCT04543617

Recruiting locations

countries

United StatesArgentinaAustraliaAustriaBelgiumChinaFranceGermanyGreeceHungaryIsraelItalyJapanKenyaMoroccoNew ZealandPolandPortugalRussiaSouth AfricaSouth KoreaSpainSwitzerlandTaiwanThailandTurkey (Türkiye)UkraineUnited Kingdom

Interventions studied

TiragolumabAtezolizumabTiragolumab Matching PlaceboAtezolizumab Matching Placebo

Lead sponsor

Hoffmann-La Roche

Target enrolment

760 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Sep 10, 2020

Last updated on the registry

Jul 23, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
* Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
* dCRT treatment according to regional oncology guidelines for esophageal cancer
* Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
* Adequate hematologic and end-organ function prior to randomization
* Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
* Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.

Key Exclusion Criteria:

* 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
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.