A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world setting.

Detailed Description
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The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.

Official Title
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A Non-interventional Observational Study of Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced / Recurrent Gastric Cancer

Conditions
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Stomach Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed advanced or recurrent gastric cancer Have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable Have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study. Exclusion Criteria: Treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (participants who have received prior perioperative chemotherapy and participants who have received prior bisphosphonates for osseous metastases may be enrolled) Confirmed to be positive for HER2 Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects Initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site. Judged by the investigators to be inappropriate for enrollment in this study

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with previously untreated advanced/recurrent gastric cancer (GC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | Up to approximately 4 years | 
| Objective response rate (ORR) |  | Up to approximately 4 years | 
| Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |  | Up to approximately 4 years | 
| Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation |  | Up to approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | Up to approximately 4 years | 
| Duration of response (DOR) |  | Up to approximately 4 years | 
| Duration of treatment (DOT) |  | Up to approximately 4 years | 
| Time to next treatment (TNT) |  | Up to approximately 4 years | 
| Number of participants who have received subsequent therapy |  | Up to approximately 4 years | 
| Incidence of Adverse Events (AEs) |  | Up to approximately 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nivolumab, Advanced or Recurrent, Gastric Cancer