Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
NCT ID: NCT04732494
Last Updated: 2025-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2021-03-31
2023-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: Tislelizumab plus Ociperlimab
Participants received 200 milligrams (mg) tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Arm B: Tislelizumab plus Placebo
Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Placebo
Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.
Interventions
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Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Placebo
Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have progressive disease during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
3. Have measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. Have confirmed programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% in tumor tissues tested by the central lab.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Exclusion Criteria
2. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
3. Evidence of complete esophageal obstruction not amenable to treatment.
4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Quanzhou First Hospital of Fujian Province
Quanzhou, Fujian, China
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Lanzhou University Second Hospital
Gansu, Gansu, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Meizhou Hospital Affiliated to Sun Yat-sen University
Guangzhou, Guangdong, China
Hainan Third People's Hospital
Sanya, Hainan, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai Provincial People's Hospital
Qinghai, Qinghai, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
People's Hospital of Deyang City
Deyang, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
First Affiliated Hospital of Kunming Medical University
Yunnan, Yunnan, China
Beijing Cancer Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, , China
The First People's Hospital of Changzhou
Changzhou, , China
Fujian Cancer Hospital
Fujian, , China
The First Affiliated Hospital of Fujian Medical University
Fujian, , China
Zhongshan Hospital Xiamen University
Fujian, , China
Cancer Hospital of Shantou University Medical College
Guangdong, , China
Nanfang Hospital of Southern Medical University
Guangdong, , China
Sun Yat-sen University Cancer Center
Guangdong, , China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangdong, , China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangdong, , China
Guangxi Medical University Affiliated Tumor Hospital
Guangxi, , China
Hainan General Hospital
Hainan, , China
Affiliated Hospital of Hebei University
Hebei, , China
The Second Hospital of Anhui Medical University
Hefei, , China
Harbin Medical University Cancer Hospital
Heilongjiang, , China
Henan Cancer Hospital
Henan, , China
The First Affiliated Hospital of Xinxiang Medical University
Henan, , China
The First Affiliated Hospital of Zhengzhou University
Henan, , China
Hubei Cancer Hospital
Hubei, , China
Xiangyang Central Hospital
Hubei, , China
Hunan Cancer Hospital
Hunan, , China
The First Affiliated Hospital of Nanchang University
Jiangxi, , China
The Second Affiliated Hospital of Nanchang University
Jiangxi, , China
Linyi Cancer Hospital
Shandong, , China
Weifang People's Hospital
Shandong, , China
Shanghai Chest Hospital
Shanghai, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
Sichuan Provincial People's Hospital
Sichuan, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
Northern Jiangsu People's Hospital
Yangzhou, , China
Hangzhou Cancer Hospital
Zhejiang, , China
Hwa Mei Hospital, University of Chinese Academy of Sciences
Zhejiang, , China
Centre Hospitalier Universitaire d'Amiens - Hopital Sud
Amiens, Picardie, France
Hôpital de la Timone
Marseille, , France
Hopital Europeen Georges Pompidou - Digestive Oncology
Paris, , France
CHU de Poitiers
Poitiers, , France
Ajou University Hospital
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Jeongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Institut Catala D'Oncologia
L'Hospitalet de Llobregat, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Clinico Universitario de Valencia - Incliva
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Chiayi Chang Gung Memorial Hospital
Chiayi City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Chulabhorn Hospital
Bangkok, , Thailand
Phramongkutklao Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, , Thailand
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, , Thailand
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-004658-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20213241/CTR20210243
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-A1217-203
Identifier Type: -
Identifier Source: org_study_id
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