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

JRCT ID: jRCT2031200166

Registered date:20/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Locally Advanced Esophageal Squamous Cell Carcinoma
• Date of first enrollment: 26/11/2020
• Target sample size: 750
• Countries of recruitment: ARGENTINA,Japan,AUSTRALIA,Japan,AUSTRIA,Japan,BELGIUM,Japan,CHINA,Japan,CZECH,Japan,FRANCE,Japan,GERMANY,Japan,GREECE,Japan,HUNGARY,Japan,ISRAEL,Japan,ITALY,Japan,NEW ZEALAND,Japan,POLAND,Japan,PORTUGAL,Japan,KOREA,Japan,RUSSIA FEDERATION,Japan,SOUTH AFRICA,Japan,SPAIN,Japan,SWITZERLAND,Japan,TAIWAN,Japan,THAILAND,Japan,TURKEY,Japan,UKRAINE,Japan,UNITED KINGDOM,Japan,UNITED STATES,Japan,GEORGIA,Japan,KENYA,Japan,MOROCCO,Japan
• Study type: Interventional

Intervention(s)

Tiragolumab:600 mg administered by IV infusion on Day 1 of each 21-day cycle
Atezolizumab:1200 mg administered by IV infusion on Day 1 of each 21-day cycle

Outcome(s)

Primary Outcome

Efficacy
Observation/Inspection, RECIST v1.1

Secondary Outcome

Safety,Efficacy,Phamacokinetics
Observation/Inspection, RECIST v1.1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 and is not expected to undergo tumor resection during the course of the study
- Definitive concurrent chemoradiation treatment according to regional oncology guidelines for esophageal cancer
- Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens, collected prior to initiation of definitive concurrent chemoradiotherapy
- Adequate hematologic and end-organ function

Exclude 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

Related Information

• Primary Sponsor: Clinical trials information
• Secondary ID(s): NCT04543617