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Clinical Trials List

Protocol NumberONO-4538-37
NCT Number(ClinicalTrials.gov Identfier)NCT02746796

2016-07-05 - 2020-07-05

Phase II

Terminated10

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C16

Malignant neoplasm of stomach

ONO-4538 Phase II/III Study Multicenter, Open-Label, Randomized Study in Patients with Unresectable Advanced or Recurrent Gastric Cancer

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    ONO Pharmaceutical Co. Ltd./Bristol-Myers Squibb Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Yee Chao Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

6 Completed

Audit

CRO

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 陳彥仰 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Li-Tzong Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Principal Investigator Jaw-Yuan Wang Division of Gastroenterological Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 林建良 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 楊陽生 Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Li-Yuan Bai 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Completed

Audit

None

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

10 Completed

Audit

None

Principal Investigator Jaw-Yuan Wang 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

None

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Condition/Disease

Advanced or Recurrent Gastric Cancer

Objectives

This is a multicenter, open-label, randomized study aimed to evaluate the efficacy and safety of ONO-4538 in combination with chemotherapy using fluoropyrimidines and platinum agents (SOX therapy, tegafur–gimeracil–oteracil potassium + oxaliplatin; CapeOX therapy, capecitabine + oxaliplatin), in comparison with SOX therapy or CapeOX therapy (hereinafter, chemotherapy) alone, in human epidermal growth factor receptor type-2 (HER2)-negative, unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy.

Test Drug

Nivolumab

Active Ingredient

Nivolumab

Dosage Form

Solution for Infusion

Dosage

100 mg/vial

Endpoints

Primary Outcome Measures :
1. Progression-free survival (central assessment by IRRC) (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 48 months) ]
2. Overall survival (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]

Secondary Outcome Measures :
1. Objective response rate (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
2. Progression-free survival (assessment by the site investigator)(only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
3. Duration of response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
4. Disease control rate (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
5. Time to response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
6. Best overall response (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
7. Percent change in the sum of diameters of target lesions (only Part 2) [ Time Frame: Up to study completion (estimated time frame: 54 months) ]
8. Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Up to 28 days from last dose ]
9. Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Up to 28 days from last dose ]

Inclution Criteria

Inclusion Criteria
After providing written consent before participation in the study, patients must fulfill all of the following criteria for randomization. If a randomized subject is found not to meet any of the following criteria before the first dose of the investigational products, the subject will not be started on the study treatment but will be withdrawn from the study.
1. Sex: Men and women
2. Age (at the time of informed consent): 20 years and older
3. Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be adenocarcinoma and has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
For patients who have received neoadjuvant or adjuvant chemotherapy, the last regimen must be completed by at least 180 days before randomization in the study.
4. Have measurable lesions as defined in RECIST Guideline Version 1.1 on CT or MRI images within 14 days before randomization in the study
5. Able to provide tumor tissue specimens (archival or fresh biopsy specimens) for PD-L1 expression analysis (prior to randomization in Part 2). For patients who are unable to undergo another biopsy, archival specimens may be used as an alternative. If archival specimens are provided for analysis, it is desirable that subjects do not receive systemic anticancer agents after collection of these specimens.
6. ECOG PS score 0 or 1
7. Have a life expectancy of at least 3 months
8. Have latest laboratory data meeting the criteria below within 7 days before randomization. If the date of the laboratory tests at randomization is not within 7 days before the first dose of the investigational products, testing should be repeated within 7 days before the first dose of the investigational products, and the latest laboratory data before the first dose of the investigational products must be confirmed to meet the following criteria. Of note, laboratory data will not be valid if the patient has received a granulocyte colony stimulating factor (G-CSF) or blood transfusion within 14 days before testing.
・ White blood cells 3000/mm3 and neutrophils 1500/mm3
・ Platelets 100000/mm3
・ Hemoglobin 9.0 g/dL
・ Aspartate aminotransferase (glutamic-oxaloacetic transaminase) (AST [GOT]) and alanine aminotransferase (glutamic-pyruvic transaminase) (ALT [GPT]) 3.0  upper limit of normal (ULN) of the study site (or 5.0  ULN in patients with liver metastases)
・ Total bilirubin 2.0  ULN
・ Creatinine 1.5  ULN or creatinine clearance (either measured value or estimated value using the Cockcroft-Gault equation) >60 mL/min
9. Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons)#1 must agree to use contraception#2 from the time of informed consent until at least 23 weeks after the last dose of the investigational products or the combined chemotherapy, whichever comes later. Also, women must agree not to breastfeed from the time of informed consent until at least 18 weeks after the last dose of the investigational products or the combined chemotherapy, whichever comes later.
10. Men must agree to use contraception#2 from the start of the study treatment until at least 31 weeks after the last dose of the investigational products or the combined chemotherapy, whichever comes later.
#1: Women of childbearing potential are defined as all women after the onset of menstruation who are not post-menopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Post-menopause is defined as amenorrhea for 12 consecutive months without specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception such as contraceptive barriers are regarded as having childbearing potential.
#2: Patients must agree to use at least two of the following different contraceptive methods: vasectomy and condoms for male patients or male partners of female patients, and tubal ligation, pessary, intrauterine devices, and oral contraceptives for female patients or female partners of male patients.

Exclusion Criteria

Exclusion Criteria
Patients meeting any of the following criteria at assessment for randomization will be excluded from the study. If a randomized subject is found to meet any of the following criteria before the first dose of the investigational products, the subject will not be started on the study treatment but will be withdrawn from the study.
1. Patients with HER2-positive or indeterminate gastric cancer (Determination for positive is made on the basis of the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry [IHC], or 2+ by IHC and positive by in situ hybridization [ISH]).
2. Have marked malnutrition. Patients will be excluded from the study if they are receiving enteral nutrition or intravenous hyperalimentation, or require continuous infusion therapy with
hospitalization. Patients whose nutritional status is well controlled for at least 28 days before randomization may be enrolled in the study.
3. Unable to take oral medicines
4. Have multiple cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder cancer, and any other cancers that have not recurred for at least 5 years)
5. Have a current or past history of severe hypersensitivity to any other antibody products
6. Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
7. Have a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging (preferably CT) or clinical findings
8. Have concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
9. Have brain or meninx metastases. Patients may be randomized for the study if they are asymptomatic and require no treatment.
10. Have pericardial fluid, pleural effusion, or ascites requiring treatment
11. Have uncontrollable, tumor-related pain
12. Have experienced a transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before randomization
13. Have a history of uncontrollable or significant cardiovascular disease meeting any of the following;
・ myocardial infarction within 180 days before randomization
・ uncontrollable angina pectoris within 180 days before randomization
・ New York Heart Association (NYHA) Class III or IV congestive heart failure
・ uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure 150 mmHg or diastolic blood pressure 90 mmHg lasting 24 hours or more)
・ arrhythmia requiring treatment
14. Are receiving or require anticoagulant therapy (other than antiplatelet therapy including low-dose aspirin) for a disease
15. Have uncontrollable diabetes mellitus
16. Have systemic infection requiring treatment
17. Are contraindicated for oxaliplatin
18. Are contraindicated for a tegafur–gimeracil–oteracil potassium combination drug or capecitabine (Part 1 only)
19. Are contraindicated for fluoropyrimidines that are used as a combination in Part 2 (either tegafur–gimeracil–oteracil potassium combination drug or capecitabine) (Part 2 only)
20. Require or, within 28 days before randomization, have received systemic corticosteroids (except for temporary use, e.g., for examination, prophylaxis of allergic reactions, or reduction of radiotherapy-related edema) or immunosuppressants
21. Have undergone surgical adhesion of the pleura or pericardium within 28 days before randomization
22. Have undergone surgery (any surgery involving general anesthesia) within 28 days before randomization
23. Have undergone surgery (any surgery involving local or topical anesthesia) within 14 days before randomization
24. Have received radiotherapy for gastric cancer within 28 days before randomization or radiotherapy for bone metastases within 14 days before randomization
25. Have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before randomization
26. Have a positive test result for human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody, human T-lymphotropic virus-1 (HTLV-1) antibody, hepatitis B surface protein (HBs) antigen, or hepatitis C virus (HCV) antibody
27. Have a negative HBs antigen test, but have a positive test result for either HBs antibody or HBc antibody with a detectable level of hepatitis B virus-deoxyribonucleic acid (HBV-DNA)
28. Are pregnant or breastfeeding, or possibly pregnant
29. Have received any other unapproved drug (e.g., marketed drugs unapproved for gastric cancer, investigational use of drugs, unapproved combined formulations, unapproved dosage forms) within 28 days (or within 90 days for antibody products) before randomization
30. With peripheral neuropathy of Grade ≥2
31. History of adverse reactions of Grade ≥3 in previous adjuvant therapy containing tegafur–gimeracil–oteracil potassium combination drug or capecitabine.
32. Have previously received ONO-4538 (MDX-1106 or BMS-936558), anti-programmed cell death-1 (PD-1) antibody, anti-PD-L1 antibody, anti-programmed cell death-ligand 2 (PD-L2) antibody, anti-CD137 antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells
33. Are incapable of providing consent for specific reasons, such as concurrent dementia
34. Are otherwise inappropriate for this study in the investigator’s or subinvestigator’s opinion.

The Estimated Number of Participants

  • Taiwan

    65 participants

  • Global

    650 participants

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