NCT04543617已完成3 期
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 760
- 试验地点
- 313
- 主要终点
- Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm B: Tiragolumab Placebo + Atezolizumab
Experimental
Participants will receive atezolizumab followed by tiragolumab matching placebo.
干预措施: Tiragolumab Matching Placebo (Drug)
Arm A: Tiragolumab + Atezolizumab
Experimental
Participants will receive atezolizumab followed by tiragolumab.
干预措施: Atezolizumab (Drug)
Arm A: Tiragolumab + Atezolizumab
Experimental
Participants will receive atezolizumab followed by tiragolumab.
干预措施: Tiragolumab (Drug)
Arm C: Tiragolumab Placebo + Atezolizumab Placebo
Placebo Comparator
Participants will receive matching placebos to tiragolumab and atezolizumab.
干预措施: Atezolizumab Matching Placebo (Drug)
Arm B: Tiragolumab Placebo + Atezolizumab
Experimental
Participants will receive atezolizumab followed by tiragolumab matching placebo.
干预措施: Atezolizumab (Drug)
Arm C: Tiragolumab Placebo + Atezolizumab Placebo
Placebo Comparator
Participants will receive matching placebos to tiragolumab and atezolizumab.
干预措施: Tiragolumab Matching Placebo (Drug)
结局指标
主要结局
Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)
时间窗: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Arm A vs Arm C: Overall Survival (OS)
时间窗: From randomization to death from any cause (up to approximately 6 years)
Arm B vs Arm C: OS
时间窗: From randomization to death from any cause (up to approximately 6 years)
次要结局
- Arm B vs Arm C: Investigator-Assessed PFS(From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years))
- Arm A vs Arm B: Investigator-Assessed PFS(From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years))
- Arm A vs Arm B: OS(From randomization to death from any cause (up to approximately 6 years))
- Independent Review Facility (IRF)-Assessed PFS(From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years))
- Investigator-Assessed Confirmed Objective Response Rate (ORR)(From randomization up to approximately 6 years)
- IRF-Assessed Confirmed ORR(From randomization up to approximately 6 years)
- Investigator-Assessed Duration of Objective Response (DOR)(From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years))
- IRF-Assessed DOR(From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years))
- Percentage of Participants With Adverse Events (AEs)(Up to approximately 6 years)
- Serum Concentration of Tiragolumab(Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to approximately 6 years))
- Serum Concentration of Atezolizumab(Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years))
- Percentage of Participants With ADAs to Atezolizumab(Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years))
- Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30(Up to approximately 6 years)
- Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18(Up to approximately 6 years)
- Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab(Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years))
研究者
研究点 (313)
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