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OpenTrials
Active, Not Recruiting

NCT Number: NCT07663786

Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Daily Clinical Practice

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Esophageal Adenocarcinoma Adenocarcinoma Of Esophagus Gastric Adenocarcinoma Gastro-esophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

As per product label

Primary outcomes

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

    Time frame: Up to 24 months

    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.

Secondary outcomes

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

    Time frame: Baseline

  4. Number of participants eligible for first-line nivolumab treatment

    Time frame: Baseline

  5. Number of eligible participants who received first-line nivolumab treatment

    Time frame: Up to 24 months

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

ENDURANCE: Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Dutch Daily Clinical Practice. Part B1

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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