Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Daily Clinical Practice

N/AActive Not RecruitingNCT07663786

Bristol-Myers Squibb726 enrolled

Overview

This study uses existing cancer registry and health record data to understand how nivolumab is used in routine care in the Netherlands for adults with advanced cancers of the esophagus, gastroesophageal junction, or stomach.

Study Type

OBSERVATIONAL

Enrollment

726

Conditions

Esophageal Adenocarcinoma Gastro-esophageal Junction Adenocarcinoma Gastric Adenocarcinoma

Interventions

NivolumabDRUG

As per product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Registered in the Netherlands Cancer Registry (NCR) * Diagnosed with Esophageal Adenocarcinoma (EAC), Gastro-esophageal Junction Adenocarcinoma (GEJAC), or Gastric Adenocarcinoma (GAC) from 01-Aug-2022 to 31-Jul-2024 * Age ≥18 years at diagnosis * Unresectable advanced (cT4B) or synchronous metastatic (cM1) disease at diagnosis * (Cohort 2) Programmed cell Death Ligand 1 (PD-L1) CPS ≥5 * (Cohort 3) Received nivolumab as part of first-line treatment Exclusion Criteria: * Neuro-endocrine carcinomas or non-epithelial cancers of esophagus/ gastroesophageal junction /stomach * Positive HER2 expression

Locations (1)

Amsterdam UMC

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Overall survival (OS) among participants treated with first-line nivolumab

Time from start of first-line nivolumab to death from any cause among participants in Cohort 3. Associations between baseline demographic, clinical, and treatment characteristics and overall survival will be evaluated using Cox proportional hazards models.

Time frame: Up to 24 months

Secondary Outcomes

Number of participants who underwent Programmed cell Death Ligand 1 (PD-L1) testing prior to treatment initiation

Associations between baseline demographic and clinical characteristics and likelihood of PD-L1 testing will be evaluated using logistic regression models.

Time frame: Baseline

Number of participants by Programmed cell Death Ligand 1 (PD-L1) diagnostic antibody

Time frame: Baseline

Number of participants tested for Programmed cell Death Ligand1 (PD-L1) who meet Combined Positive Score (CPS) thresholds

Time frame: Baseline

Number of participants eligible for first-line nivolumab treatment

Time frame: Baseline

Number of eligible participants who received first-line nivolumab treatment

Associations between baseline demographic and clinical characteristics and receipt of first-line nivolumab will be evaluated using logistic regression models.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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