A Study of Atezolizumab with or without Tiragolumab (Anti-TIGITAntibody) in Patients with Unresectable Esophageal Squamous CellCarcinoma whose Cancers have not Progressed following DefinitiveConcurrent Chemoradiotherapy.

Phase 1

• Conditions: Esophageal squamous cell carcinoma; MedDRA version: 21.0Level: LLTClassification code 10055476Term: Esophageal squamous cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001178-31-PL
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-14
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Age >=18 years
• Eastern Cooperative Oncology Group 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 and is not expected to undergo tumor resection during the
course of the study
• Definitive concurrent chemoradiation treatment (dCRT) according to regional
oncology guidelines for esophageal cancer
• Representative archival formalin-fixed, paraffin-embedded tumor
specimens, collected prior to initiation of dCRT
• Adequate hematologic and end-organ function
•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 to avoid exposing the embryo..

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 465

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 Common
Terminology Criteria for Adverse Events, Version 5.0 (NCI 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
• Malignancy 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 EGFR
inhibitors, with therapeutic intent for esophageal cancer prior to
randomization.
• Severe infection within 4 weeks prior to randomization, including, but
not limited to, hospitalization for complications of infection, bacteremia,
or severe pneumonia, or any active infection that, in the opinion of the
investigator, could impact patient safety.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified