NCT06256328

A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	ONO-4578	Specified dose, once daily
DRUG	Oxaliplatin	Specified dose on specified days
DRUG	Capecitabine	Specified dose on specified days
DRUG	S-1	Specified dose on specified days
DRUG	Nivolumab	Specified dose on specified days
DRUG	Placebo	Specified dose, once daily

Timeline

• Start date: 2024-01-10
• Primary completion: 2025-10-09
• Completion: 2027-07-31
• First posted: 2024-02-13
• Last updated: 2026-03-13

Locations

63 sites across 3 countries: Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study