drugset / Trial / 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)

NCT06256328

Phase 2 Active not recruiting 226 enrolled Ono Pharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2024-01-10
Primary completion
2025-10-09
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986310 Small molecule
Background Capecitabine Small molecule
Background Nivolumab Monoclonal antibody
Background Oxaliplatin Small molecule
Background S-1 Small molecule

Indications