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A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
Sponsor: Ono Pharmaceutical Co., Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma. Participants will: * Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy. * Make visits to the clinic for checkups and tests. * Answer questions about their health throughout the trial.
Official title: A Phase 3, Randomized, Multicenter, Double-blind Study of the Efficacy and Safety of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With HER2-negative, PD-L1-Positive Advanced or Metastatic Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2027-02
Completion Date
2031-01
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
ONO-4578
ONO-4578 will be administered to participants at a specified dose once daily.
Placebo
Matching placebo for ONO-4578 will be administered to participants once daily.
Nivolumab
Nivolumab will be administered to participants at a specified dose on specified days.
Oxaliplatin
Oxaliplatin will be administered to participants at a specified dose on specified days.
Capecitabine
Capecitabine will be administered to participants at a specified dose on specified days.
Tegafur-gimeracil-oteracil potassium (S-1)
S-1 will be administered to participants at a specified dose on specified days.
Fluorouracil
Fluorouracil will be administered to participants at a specified dose on specified days.
Leucovorin Calcium
Leucovorin Calcium will be administered to participants at a specified dose on specified days.
Levoleucovorin
Levoleucovorin will be administered to participants at a specified dose on specified days.