Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France (METAGIO)

April 2, 2026 updated by: Bristol-Myers Squibb

A French, Prospective, Observational, Multicenter Study of Patients Treated With Nivolumab Plus Chemotherapy as First Line Treatment in Advanced or Metastatic Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma or Gastric Adenocarcinoma [METAGIO]

A study to estimate the overall survival in real-life conditions in France of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • France
      • Paris, France, 75002
        • Local Institution - 0001
      • Paris, France
        • Kappa Santé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants in France diagnosed with Gastric Adenocarcinoma, Gastro-Esophageal Junction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or Esophageal Squamous Cell Carcinoma (ESCC) and treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy

Description

Inclusion Criteria:

Cohorts 1 & 2

  • Adult participants (at least 18 years of age at time of treatment decision)
  • Participants treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy (according to the French current marketing authorization) for the treatment of Gastric Adenocarcinoma, Gastro-Esophageal Junction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or Esophageal Squamous Cell Carcinoma (ESCC) and prior to study participation.
  • Participants who provided oral informed consent to participate in the study

Cohort 1 only • Diagnosis of untreated HER2 negative advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma or EAC whose tumor express PD-L1 with a CPS ≥5

Cohort 2 only

• Diagnosis of untreated unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression (TPS) ≥1%

Exclusion Criteria:

Cohorts 1 & 2

  • Participants with a primary diagnosis of a cancer other than advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC, within the past 5 years.
  • Participants currently enrolled in an interventional clinical trial for his/her advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC.
  • Pregnant women
  • Participants under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma
Drug: nivolumab + chemotherapy
As prescribed by the treating clinician, as per product label
Cohort 2
Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma
Drug: nivolumab + chemotherapy
As prescribed by the treating clinician, as per product label

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant treatment history
Time Frame: Baseline
Baseline
Participant socio-demographics
Time Frame: Baseline
Baseline
Cause of death (where available)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Disease progression
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
As assessed by the Site Investigator
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Progression-free survival (PFS)
Time Frame: Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to treatment discontinuation (TTD)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to failure of strategy (TFS)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to next Treatment (TTNT)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Second progression-free survival (PFS2)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Treatment Free Interval (TFI)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Overall tumor response (ORR)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Response rate
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Duration of response (DOR)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant clinical characteristics
Time Frame: Baseline
Baseline
Nivolumab treatment regime
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Chemotherapy treatment regime
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Reason for treatment discontinuation
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent non-systemic treatment received post first-line treatment
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent systemic treatment received post first-line treatment
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent systemic treatment effectiveness
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant adverse events (AEs)
Time Frame: Up to 3 years
Up to 3 years
Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L)
Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-1408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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