Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Study Overview
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Brief Summary
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The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab 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, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.

Official Title
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A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Tegafur-gimeracil-oteracil potassium
* Drug: Oxaliplatin
* Drug: Capecitabine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed adenocarcinoma of the stomach Patients without a remnant cancer (R0) who have undergone gastrectomy Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 Exclusion Criteria: Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer Multiple primary cancers A current or past history of severe hypersensitivity to any other antibody products Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab group<br>Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off. | Drug: Nivolumab<br>* Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).<br>* Other names: MDX-1106;Drug: Tegafur-gimeracil-oteracil potassium<br>* Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off<br>Drug: Oxaliplatin<br>* Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.<br>Drug: Capecitabine<br>* Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.<br>|
| Placebo Comparator: Placebo group<br>Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off. | Drug: Tegafur-gimeracil-oteracil potassium<br>* Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off<br>Drug: Oxaliplatin<br>* Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.<br>Drug: Capecitabine<br>* Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.<br>Drug: Placebo<br>* Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival (RFS) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 5 years | 
| 3-year OS rate |  | 3 years | 
| 5-year OS rate |  | 5 years | 
| 3-year RFS rate |  | 3 years | 
| 5-year RFS rate |  | 5 years | 
| Safety will be analyzed through the incidence of adverse events, serious adverse events |  | Up to 28 days from last dose | 
| Safety will be analyzed through the incidence of laboratory abnormalities |  | Up to 28 days from last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX