Esophageal AdenocarcinomaNCT07663786
Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Daily Clinical Practice
An observational study of Esophageal Adenocarcinoma and Gastro-esophageal Junction Adenocarcinoma, run by Bristol-Myers Squibb at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
- What is being tested?
- Nivolumab
- How many people
- 726 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Oct 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Neuro-endocrine carcinomas or non-epithelial cancers of esophagus/ gastroesophageal junction /stomach
- Positive HER2 expression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENDURANCE: Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Dutch Daily Clinical Practice. Part B1
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
- Being tested
- Nivolumab
- Keywords
- Esophageal Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (5)
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.
Measured: Baseline
Number of participants by Programmed cell Death Ligand 1 (PD-L1) diagnostic antibody
Measured: Baseline
Number of participants tested for Programmed cell Death Ligand1 (PD-L1) who meet Combined Positive Score (CPS) thresholds
Measured: Baseline
Number of participants eligible for first-line nivolumab treatment
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start9 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663786
- Sponsor's protocol ID
- CA209-1583
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDURANCE: Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Dutch Daily Clinical Practice. Part B1
- ClinicalTrials.gov ID
- NCT07663786
- Acronym / sponsor ID
- CA209-1583
- Conditions
- Esophageal Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
- Keywords
- Esophageal Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 726 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: NivolumabSubset of Cohort 2 who received nivolumab as part of first-line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Neuro-endocrine carcinomas or non-epithelial cancers of esophagus/ gastroesophageal junction /stomach
- Positive HER2 expression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAs per product label | Drug | Cohort 3: Participants treated with first-line nivolumab |
Primary outcome
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.
5 secondary outcomes
Number of participants who underwent Programmed cell Death Ligand 1 (PD-L1) testing prior to treatment initiation
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
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Adenocarcinoma and Gastro-esophageal Junction Adenocarcinoma, run by Bristol-Myers Squibb at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) among participants treated with first-line nivolumab (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.