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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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 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

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
Intervention / Treatment
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

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

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

Bristol-Myers Squibb

Investigators

  • 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)

December 10, 2024

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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