A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this observational study is to assess the effectiveness and safety of nivolumab in participants with previously untreated advanced or metastatic Gastric Cancer (GC), Gastro-oesophageal Junction (GEJ) Adenocarcinoma, or Oesophageal Adenocarcinoma (EAC).

Official Title
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A National, Prospective, Non-interventional Study (NIS) of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Patients With HER2 Negative Advanced or Metastatic Gastric, Gastro-oesophageal Junction or Oesophageal Adenocarcinoma Whose Tumours Express PD-L1 With a CPS ≥5

Conditions
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Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of HER2 negative advanced or metastatic HER2-negative GC, GEJ adenocarcinoma or EAC whose tumours express PD-L1 with a CPS ≥ 5 Whose physician has decided to start a treatment with nivolumab (according to the German marketing authorization) for the treatment of GC, GEJ adenocarcinoma or EAC and prior to study participation Exclusion Criteria: Previous malignancy within 3 years or concomitant malignancy, except: those with a 5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer. Participants currently included in an interventional clinical trial for their advanced or metastatic GC, GEJ adenocarcinoma or EAC. Participants who have completed their participation in an interventional trial or who are not receiving any study drug anymore and who are only in the follow-up Phase for OS can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.

Ages Eligible for Study
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Minimum Age: 18 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 or metastatic gastric cancer (GC), gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma (EAC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Defined as time since initial diagnosis and treatment with nivolumab to either the first disease progression date or last known tumour assessment date, or death due to any cause, whichever occurs first. | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 
| Overall response rate (ORR) | Defined as investigator assessed complete response, partial response, stable disease, or progressive disease. | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 
| Duration of response | Defined as time from response to progression | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 
| Incidence of Adverse Events (AEs) |  | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 
| Overall Survival (OS) | Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause. | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 
| OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS) |  | From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPDIVO®, Nivolumab, Advanced or Metastatic, Gastric Cancer, Prospective Study, Gastro-oesophageal junction, Oesophageal Cancer