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)

A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as Chemotherapy) Versus 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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05144854

Enrollment

626

Registered

2021-12-03

Start date

2021-11-05

Completion date

2027-05-31

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Brief 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).

Interventions

Specified dose on specified days

DRUGIpilimumab

Specified dose on specified days

DRUGOxaliplatin

Specified dose on specified days

DRUGCapecitabine

Specified dose on specified days

DRUGS-1

Specified dose on specified days

Sponsors

Ono Pharmaceutical Co. Ltd

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	up to 3 years

Secondary

Measure	Time frame
Objective response rate (ORR) (site investigator assessment)	up to 3 years
Best overall response (BOR) (site investigator assessment)	up to 3 years
Duration of response (DOR) (site investigator assessment)	up to 3 years
Disease control rate (DCR) (site investigator assessment)	up to 3 years
Progression-free survival (PFS) (site investigator assessment)	up to 3 years
Maximum percent change in the sum diameters of the target lesions (site investigator assessment)	up to 3 years
Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)	up to 3 years
Adverse event	Up to 30 days after the last dose
Time to response (TTR) (site investigator assessment)	up to 3 years

Countries

Japan, South Korea, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026