Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer

Study Overview
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Brief Summary
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The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.

Official Title
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ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: ONO-4538
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men & women ≥20 years of age Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) Histologically confirmed adenocarcinoma Refractory to or intolerant of standard therapy ECOG Performance Status score 0 or 1 A life expectancy of at least 3 months Exclusion Criteria: Current or past history of severe hypersensitivity to any other antibody products Patients with multiple primary cancers Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment Patients with active, known or suspected autoimmune disease

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-4538 Arm<br>ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | Drug: ONO-4538<br> <br> |
| Placebo Comparator: Placebo Arm<br>Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to study completion (estimated time frame: 30 months), every 2 weeks in principle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Up to study completion (estimated time frame: 30 months), every 2 weeks in principle | 
| Objective response rate |  | Up to study completion (estimated time frame: 30 months), every 6 weeks in principle | 
| Duration of response |  | Up to study completion (estimated time frame: 30 months), every 6 weeks in principle | 
| Safety will be analyzed through the incidence of adverse events, serious adverse events |  | Continuously throughout study treatment and up to 28 days from last dose | 
| Safety will be analyzed through the incidence of laboratory abnormalities |  | Continuously throughout study treatment and up to 28 days from last dose |