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)

Phase 2Active Not RecruitingNCT06256328

Ono Pharmaceutical Co. Ltd210 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

210

Conditions

Gastric Cancer

Interventions

ONO-4578DRUG

Specified dose, once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma * Patients have not been treated with systemic chemotherapy as first-line therapy * Patients who can provide tumor tissue samples Exclusion Criteria: * Patients unable to take oral medicines * Patients with HER2-positive * Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine * Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment * Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis * Patients with headache and/or nausea associated with brain metastasis

Locations (63)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

NHO Shikoku Cancer Center

Matsuyama, Ehime, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

NHO Kyushu Cancer Center

Outcomes

Primary Outcomes

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

Time frame: up to 2years

Secondary Outcomes

Overall survival (OS)

Time frame: up to 2years

Objective response rate (ORR) (site investigator assessment)

Time frame: up to 2years

Best overall response (BOR) (site investigator assessment)

Time frame: up to 2years

Duration of response (DOR) (site investigator assessment)

Time frame: up to 2years

Disease control rate (DCR) (site investigator assessment)

Time frame: up to 2years

Time to response (TTR) (site investigator assessment)

Time frame: up to 2years

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

Time frame: up to 2years

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

Time frame: up to 2years

Adverse event (AE)

Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0

Time frame: Up to 30 days after the last dose