Overview

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 Canc

Status:
Not yet recruiting

Trial end date:
2027-05-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ono Pharmaceutical Co. Ltd

Treatments:

Capecitabine
Ipilimumab
Nivolumab
Oxaliplatin
Tegafur

Criteria

Inclusion Criteria:

1. Participants with unresectable advanced or recurrent gastric cancer (including
esophagogastric junction cancer) that has been histologically confirmed to be
predominant adenocarcinoma

2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1

3. Participants who have a life expectancy of at least 3 months

Exclusion Criteria:

1. Participants with a history or complications of multiple cancers

2. Participants with a complication or history of severe hypersensitivity to any other
antibody products

3. Participants with concurrent autoimmune disease or a history of chronic or recurrent
autoimmune disease.