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)

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Nivolumab; Drug: Capecitabine; Drug: Placebo; Drug: ONO-4578; Drug: Oxaliplatin; Drug: S-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06256328

ONO-4578-08

Details and patient eligibility

About

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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups, including a placebo group

ONO-4578+Nivolumab+chemotherapy

Experimental group

Treatment:

Drug: S-1

Drug: Oxaliplatin

Drug: ONO-4578

Drug: Capecitabine

Drug: Nivolumab

placebo+Nivolumab+chemotherapy

Placebo Comparator group

Treatment:

Drug: S-1

Drug: Oxaliplatin

Drug: Placebo

Drug: Capecitabine

Drug: Nivolumab