A Phase 3 interventional study of Nivolumab and Tegafur-gimeracil-oteracil potassium in Gastric Cancer, sponsored by Ono Pharmaceutical Co. Ltd. Completed at 108 sites in 4 countries. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Ono Pharmaceutical Co. Ltd · Phase 3, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 800 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Ono Pharmaceutical Co. Ltd is the lead sponsor of 66 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Tegafur-gimeracil-oteracil potassium · Drug: Oxaliplatin · Drug: Capecitabine
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 · Drug: Oxaliplatin · Drug: Capecitabine · Drug: Placebo
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Also known as: BMS-936558, ONO-4538, MDX-1106
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
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.
Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Relapse-free survival (RFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
3-year OS rate
Time frame: 3 years
5-year OS rate
Time frame: 5 years
3-year RFS rate
Time frame: 3 years
5-year RFS rate
Time frame: 5 years
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time frame: Up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time frame: Up to 28 days from last dose
Showing the first 100 of 108 sites across 4 countries.
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Ono Pharmaceutical Co. Ltd