drugset / Trial / NCT05144854

A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

NCT05144854

Phase 3 Active not recruiting 626 enrolled Ono Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Timeline

Start
2021-11-05
Primary completion
2025-10-20
Completion
2027-05

Drugs

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

Indications