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)

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Ipilimumab; Drug: Oxaliplatin; Drug: S-1; Drug: ONO-4538; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05144854

ONO-4538-113

Details and patient eligibility

About

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).

Enrollment: 626 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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626 participants in 2 patient groups

ONO-4538 + ipilimumab + chemotherapy

Experimental group

Treatment:

Drug: Capecitabine

Drug: ONO-4538

Drug: S-1

Drug: Oxaliplatin

Drug: Ipilimumab

Chemotherapy

Active Comparator group

Treatment:

Drug: Capecitabine

Drug: S-1

Drug: Oxaliplatin