Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Daily Clinical Practice

NCT07663786 | Active Not Recruiting FDA Drug

• 1 other identifier: CA209-1583
• Study Type: observational
• Target: 726
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Adenocarcinoma; Gastro-esophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Keywords

Esophageal Adenocarcinoma; Gastro-esophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 months

Secondary Outcomes (5)

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

  Baseline

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

  Baseline

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

  Baseline

• Number of participants eligible for first-line nivolumab treatment

  Baseline

• Number of eligible participants who received first-line nivolumab treatment

  Up to 24 months

Study Arms (3)

Advanced/metastatic EAC/GEJAC/GAC participants

Participants diagnosed with HER2-negative unresectable advanced (cT4B) or synchronous metastatic (cM1) esophageal adenocarcinoma (EAC), gastro-esophageal junction adenocarcinoma (GEJAC), or gastric adenocarcinoma (GAC)

Cohort 2: Participants eligible for first-line nivolumab

Subset of Cohort 1 who are eligible for nivolumab treatment according to the European Medicines Association (EMA) approved indication

Cohort 3: Participants treated with first-line nivolumab

Subset of Cohort 2 who received nivolumab as part of first-line treatment

Drug: Nivolumab

Interventions

Nivolumab DRUG

As per product label

Cohort 3: Participants treated with first-line nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults in the Netherlands diagnosed with HER2-negative unresectable advanced or synchronous metastatic Esophageal Adenocarcinoma (EAC), Gastro-esophageal Junction Adenocarcinoma (GEJAC), or Gastric Adenocarcinoma (GAC) diagnosed between 01-Aug-2022 and 31-Jul-2024

You may qualify if:

• 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

You may not qualify if:

• Neuro-endocrine carcinomas or non-epithelial cancers of esophagus/ gastroesophageal junction /stomach
• Positive HER2 expression

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: October 9, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)