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Clinical Trials List

Protocol NumberONO-4538-38/BMS CA209844
NCT Number(ClinicalTrials.gov Identfier)NCT03006705

2017-01-06 - 2022-01-05

Phase III

Terminated8

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C16

Malignant neoplasm of stomach

ONO-4538 Phase III Study A multicenter, double-blind, randomized study in patients with gastric cancer undergoing postoperative adjuvant chemotherapy

  • 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 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 Yan-Shen Shan Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Principal Investigator Yi-Ping Hung Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

6 Completed

Audit

None

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

Co-Principal Investigator

Audit

None

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

Taiwan National PI

陳仁熙

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 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

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Gastric Cancer

Objectives

This is a multicenter, double-blind, randomized study intended to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with ONO-4538 in combination with tegafur–gimeracil–oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy (hereinafter, chemotherapy), in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection. Primary Objective The primary objective of the study is to evaluate the efficacy of postoperative adjuvant chemotherapy with ONO-4538 + chemotherapy in comparison with placebo + chemotherapy in pStage III gastric cancer after D2 or more extensive lymph node dissection based on the primary endpoint of relapsefree survival (RFS). Secondary Objective The secondary objective of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with ONO-4538 + chemotherapy in comparison with placebo + chemotherapy from various perspectives in pStage III gastric cancer after D2 or more extensive lymph node dissection.

Test Drug

Nivolumab

Active Ingredient

Nivolumab

Dosage Form

Solution for Infusion

Dosage

100 mg/vial

Endpoints

Primary Endpoint
Relapse-free survival (RFS) (central assessment)

Secondary Endpoints
1. Relapse Free Survival (RFS) (assessment by the site investigator)
2. 3- and 5-year RFS rate (central assessment and assessment by the site investigator)
3. Overall survival (OS)
4. 3- and 5-year OS rate

Inclution Criteria

Inclusion Criteria
Patients must fulfill all of the following criteria to be enrolled at the time of randomization, after
provision of written informed consent before participation in the study. If a randomized subject does
not meet any of the following criteria before the first dose of study treatment, the subject will be
withdrawn from the study without initiation of study treatment.
1. Sex: Men and women
2. Age (at the time of informed consent): ≥20 years, ≤80 years
3. Patients with histologically confirmed adenocarcinoma of the stomach (including
esophagogastric junction cancer)
4. Patients without a remnant cancer (R0) who have undergone gastrectomy with D2 or more
extensive lymph node dissection (including spleen-preserving [omission of lymph node No.10
dissection]) by laparotomy
5. Pathological Stage IIIA, IIIB, or IIIC gastric carcinoma according to the stage classification of
AJCC/UICC TNM Classification, 7th Edition and the Japanese Classification of Gastric
Carcinoma, 14th Edition, on the basis of overall postoperative findings
6. No hepatic, peritoneal, or distant metastasis, with negative peritoneal cytology
7. No metastasis nor recurrence based on imaging between 28 days prior to surgery and
randomization
8. Able to be randomized between Day 21 and Day 42 (Day 0 defined as the day of surgery)
9. Able to start receiving the investigational product and either protocol-specified chemotherapy,
within 14 days after randomization
10. Able to provide a tumor tissue specimen (preserved tissue specimen or most recent biopsy
tissue specimen) for PD-L1 expression analysis
11. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
12. Have latest laboratory data fulfilling the criteria below within 7 days before randomization. If
the date of laboratory tests at randomization is not within 7 days before the first dose of the
investigational product and either protocol-specified chemotherapy, testing must be repeated
within 7 days before the first dose of the investigational product and either protocol-specified
chemotherapy, and the latest laboratory data within 7 days before randomization must 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 the
testing.
- White blood cells ≥4000/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-fold the
upper limit of normal of the study site (ULN)
- Total bilirubin ≤2.0-fold the ULN
- Creatinine ≤1.5-fold the ULN or creatinine clearance >60 mL/min (measured value or
estimated value using the Cockcroft–Gault formula)
13. Women of childbearing potential (including women without menstruation because of chemical
menopause or other medical causes)#1 must agree to use contraception#2 from the time of
informed consent until at least 5 months after the last dose of study treatment or concomitant
chemotherapies, whichever is later. Women must also agree not to breastfeed from the time of
informed consent until at least 5 months after the last dose of the investigational product or
concomitant chemotherapies, whichever is later.
14. Men must agree to use contraception#2 from the time of the first dose of the investigational
products until at least 7 months after the last dose of the investigational products or
concomitant chemotherapies, whichever is 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 or
mechanical contraception such as intrauterine devicesare regarded as having childbearing
potential.
#2
: Patients must agree to use at least two of the following different contraceptive methods:
vasectomy or 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 randomization will be excluded from the study. If a
randomized subject meets any of the following criteria before the first dose of study treatment, the
subject will be withdrawn from the study without initiation of study treatment.
1. Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone
therapy) for gastric cancer
2. A ≥15% decrease of body weight from preoperative baseline at randomization
3. Unable to take medication orally
4. Multiple primary cancers (with the exception of completely resected basal cell carcinoma,
stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial
bladder cancer, or any other cancer that has not recurred for at least 5 years)
5. Unresolved postoperative complications (e.g., postoperative infection, ruptured suture,
gastrointestinal hemorrhage, pancreatic leakage) at the time of randomization
6. A current or past history of severe hypersensitivity to any other antibody products
7. Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune
disease
8. A current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on
imaging (preferably computed tomography [CT]) or clinical findings
9. Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
10. Pericardial fluid, pleural effusion, or ascites requiring treatment
11. A history of transient ischemic attack, cerebrovascular accident, thrombosis or
thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days
before randomization
12. A history of any of the following uncontrollable or significant cardiovascular diseases:
- 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 (including a pacemaker)
13. Receiving or requiring anticoagulant therapy (other than antiplatelet therapy including lowdose aspirin)
14. Uncontrollable diabetes mellitus
15. Systemic infection requiring treatment
16. Contraindicated for oxaliplatin or capecitabine (CapeOX group only)
17. Contraindicated for tegafur–gimeracil–oteracil potassium (S-1 group only)
18. 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
19. Any surgery other than for gastric cancer (any surgery involving general anesthesia) within 28
days before randomization
20. Surgery (any surgery involving local or topical anesthesia) within 14 days before
randomization
21. Received any radiopharmaceuticals (except for examination or diagnostic use of
radiopharmaceuticals) within 56 days before randomization
22. A positive test result for any of the following: 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 (HBs) antigen, or hepatitis C virus (HCV) antibody
23. A negative HBs antigen test, but a positive test result for either HBs antibody or hepatitis B
core (HBc) antibody, with a detectable level of hepatitis B virus-deoxyribonucleic acid (HBVDNA)
24. Pregnant, breastfeeding, or possibly pregnant
25. Received any other unapproved drug within 28 days (or within 90 days for antibody products)
before randomization
26. Grade ≥2 peripheral neuropathy (CapeOX group only)
27. Experienced grade ≥3 adverse drug reactions in chemotherapy including oxaliplatin or
capecitabine (CapeOX group only)
28. Experienced grade ≥3 adverse drug reactions in chemotherapy including tegafur–gimeracil–
oteracil potassium (S-1 group only)
29. Previously received ONO-4538 (MDX-1106 or BMS-936558), anti-PD-1 antibody, anti-PDL1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody or other
therapeutic antibodies or pharmacotherapies for the regulation of T-cells
30. Judged to be incapable of providing consent for certain reasons, such as concurrent dementia
31. Other patients inappropriate for this study in the opinion of the investigator or subinvestigator

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    700 participants

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