Gastric AdenocarcinomaMETAGIONCT06504615
Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France
An observational study of Gastric Adenocarcinoma and Gastro-esophageal Junction Adenocarcinoma, run by Bristol-Myers Squibb at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma (EAC)
- What is being tested?
- nivolumab + chemotherapy
- How many people
- 208 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Dec 2024to 31 Aug 2028
- 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: 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
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Gastric Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma (EAC), Esophageal Squamous Cell Carcinoma (ESCC)
- Being tested
- nivolumab + chemotherapy
- Keywords
- Gastric adenocarcinoma, Gastro-esophageal junction (GEJ) adenocarcinoma, Esophageal adenocarcinoma (EAC), Esophageal squamous cell carcinoma (ESCC)
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumab + chemotherapyDrug
As prescribed by the treating clinician, as per product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma Receives: Drug: nivolumab + chemotherapy | |
| Cohort 2 | Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma Receives: Drug: nivolumab + chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Secondary outcomes (22)
Cause of death (where available)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Disease progression
As assessed by the Site Investigator
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Progression-free survival (PFS)
Measured: Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to treatment discontinuation (TTD)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to failure of strategy (TFS)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to next Treatment (TTNT)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Second progression-free survival (PFS2)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Treatment Free Interval (TFI)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Overall tumor response (ORR)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Response rate
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Duration of response (DOR)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant socio-demographics
Measured: Baseline
Participant clinical characteristics
Measured: Baseline
Participant treatment history
Measured: Baseline
Nivolumab treatment regime
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Chemotherapy treatment regime
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Reason for treatment discontinuation
Measured: 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
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent systemic treatment received post first-line treatment
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent systemic treatment effectiveness
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant adverse events (AEs)
Measured: Up to 3 years
Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L)
Measured: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start10 Dec 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Prospective
- Enrolment
- 208 participants (actual)
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
- NCT06504615
- Sponsor's protocol ID
- CA209-1408
- Acronym
- METAGIO
- Status last verified
- Apr 2026
- First submitted
- 10 Jul 2024
- Last updated
- 3 Apr 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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]
- ClinicalTrials.gov ID
- NCT06504615
- Acronym / sponsor ID
- METAGIO / CA209-1408
- Conditions
- Gastric Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma (EAC), Esophageal Squamous Cell Carcinoma (ESCC)
- Keywords
- Gastric adenocarcinoma, Gastro-esophageal junction (GEJ) adenocarcinoma, Esophageal adenocarcinoma (EAC), Esophageal squamous cell carcinoma (ESCC)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 17 Jul 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: nivolumab + chemotherapyParticipants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma |
| Cohort 2 | – | Drug: nivolumab + chemotherapyParticipants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| nivolumab + chemotherapyAs prescribed by the treating clinician, as per product label | Drug | Cohort 1, Cohort 2 |
Primary outcome
Overall survival (OS)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
22 secondary outcomes
Cause of death (where available)
Time frame: 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
Progression-free survival (PFS)
Time frame: 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
Time to failure of strategy (TFS)
Time frame: 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
Second progression-free survival (PFS2)
Time frame: 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
Overall tumor response (ORR)
Time frame: 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
Duration of response (DOR)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant socio-demographics
Time frame: Baseline
Participant clinical characteristics
Time frame: Baseline
Participant treatment history
Time frame: Baseline
Nivolumab treatment regime
Time frame: 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
Reason for treatment discontinuation
Time frame: 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
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
Subsequent systemic treatment effectiveness
Time frame: 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
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
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 3 Apr 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma and Gastro-esophageal Junction Adenocarcinoma, run by Bristol-Myers Squibb at 2 sites in France.
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 7 inclusion and 5 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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) (time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36). 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 3 Apr 2026.