Clinical Trials List
Protocol NumberONO-4538-44/CA209649
NCT Number(ClinicalTrials.gov Identfier)NCT02872116
Completed
2017-01-17 - 2020-09-30
Phase III
Terminated1
Study ended1
ICD-10C16
Malignant neoplasm of stomach
A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE 3 STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS OXALIPLATIN PLUS FLUOROPYRIMIDINE IN SUBJECTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION CANCER
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Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
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Sponsor
ONO PHARMACEUTICAL CO., LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/24
Investigators and Locations
Co-Principal Investigator
- Yee Chao Division of Hematology & Oncology
- Chung-Pin Li Division of Hematology & Oncology
- Ming-Huang Chen Division of Hematology & Oncology
- San-Chi Chen Division of Hematology & Oncology
- Rheun-Chuan Lee Division of Radiology
The Actual Total Number of Participants Enrolled
2 Completed
Audit
None
Principal Investigator
Jen-Shi Chen
Linkou Chang Gung Medical Foundation
Taiwan National PI
陳仁熙
Co-Principal Investigator
- Wen-Chi Chou Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
7 Study ended
Condition/Disease
Gastric Cancer,Gastroesophageal Junction Cancer
Objectives
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Test Drug
Nivolumab/Ipilimumab/Oxaliplatin/Fluorouracil/Leucovorin/Capecitabine
Active Ingredient
Nivolumab
Dosage Form
Injection
Dosage
100mg/10ml
Endpoints
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Inclution Criteria
Inclusion Criteria:
Male or Female at least 18 years of age
Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
Male or Female at least 18 years of age
Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
Exclusion Criteria
Exclusion Criteria:
Presence of tumor cells in the brain or spinal cord that have not been treated
Active known or suspected autoimmune disease
Any serious or uncontrolled medical disorder or active infection
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Any positive test result for hepatitis B or C indicating acute or chronic infection
Presence of tumor cells in the brain or spinal cord that have not been treated
Active known or suspected autoimmune disease
Any serious or uncontrolled medical disorder or active infection
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Any positive test result for hepatitis B or C indicating acute or chronic infection
The Estimated Number of Participants
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Taiwan
8 participants
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Global
2032 participants
