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)

Phase 3Active Not RecruitingNCT05144854

Ono Pharmaceutical Co., Ltd.626 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

626

Conditions

Gastric Cancer

Interventions

ONO-4538DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (57)

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Osaki Citizen Hospital

Osaki-shi, Miyagi, Japan

Osaka University Hospital

Suita-shi, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Outcomes

Primary Outcomes

Overall survival (OS)

Time frame: up to 3 years

Secondary Outcomes

Progression-free survival (PFS) (site investigator assessment)

Time frame: up to 3 years

Objective response rate (ORR) (site investigator assessment)

Time frame: up to 3 years

Best overall response (BOR) (site investigator assessment)

Time frame: up to 3 years

Duration of response (DOR) (site investigator assessment)

Time frame: up to 3 years

Disease control rate (DCR) (site investigator assessment)

Time frame: up to 3 years

Time to response (TTR) (site investigator assessment)

Time frame: up to 3 years

Maximum percent change in the sum diameters of the target lesions (site investigator assessment)

Time frame: up to 3 years

Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)

Time frame: up to 3 years

Adverse event

Time frame: Up to 30 days after the last dose