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).
Study Type
OBSERVATIONAL
Enrollment
600
Local Institution - 0001
Hamburg, Germany
Overall Survival (OS)
Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months
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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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)
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Time frame: From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months