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A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma
- Cancer
- Esophageal Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- an-yang-shi
- bei-jing-shi
- Beijing
- chang-chun-shi
- chang-sha-shi
- Cheng Du Shi
- Chengde
- Chengdu
- Chongqing
- Daegu
- fo-shan-shi
- fu-zhou-shi
- Fuzhou
- Goyang-si
- guang-zhou-shi
- hang-zhou-shi
- Harbin
- he-fei-shi
- Hefei Shi
- Hong Kong Island
- jilin-city
- Kaohsiung City
- Krung Thep Maha Nakhon
- lian-yun-gang-shi
- linyi
- Luo Yang Shi
- nan-jing-shi
- Nanjing
- New Territories
- Seongnam-si
- Seoul
- shan-tou-shi
- shang-hai-shi
- Shanghai
- shen-zhen-shi
- Shenyang
- Tainan City
- Taipei City
- tambon-kho-hong
- tian-jin-shi
- wei-fang-shi
- wu-han-shi
- xi-an-shi
- xia-men-shi
- xin-xiang-shi
- yang-zhou-shi
- zheng-zhou-shi
Trial Identifier:
NCT04540211 YO42138
Trial Summary
The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma (EC). Participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase: Arm A: Atezolizumab plus Tiragolumab and PC Arm B: Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab matching placebo plus tiragolumab matching placebo (Arm B).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04540211, YO42138
Trial Identifier
Atezolizumab, Tiragolumab, Paclitaxel, Cisplatin, Atezolizumab Matching Placebo, Tiragolumab Matching Placebo
Treatments
Esophageal Cancer
Condition
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically confirmed EC
- Unresectable locally advanced, unresectable recurrent, or metastatic disease
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and end-organ function
- Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 90 days after the final dose
- Male participants with partners of childbearing potential must commit to the use of two methods of contraception and must not donate sperm for the study duration and 90 days after the final dose
Exclusion Criteria
- Palliative radiation treatment for EC within 4 weeks prior to initiation of study treatment
- Evidence of complete esophageal obstruction not amenable to treatment
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Active or history of autoimmune disease or immune deficiency or leptomeningeal disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Malignancies other than EC within 2 years prior to screening with a negligible risk of metastasis or death adequately treated with expected curative outcome
- Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with any investigational therapy prior to initiation of study treatment
- Poor peripheral venous access
- Prior allogeneic stem cell or solid organ transplantation
- Concurrent participation in another therapeutic clinical trial
For the latest version of this information please go to www.forpatients.roche.com