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Active, Not Recruiting

NCT Number: NCT06504615

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gastric Adenocarcinoma Adenocarcinoma Adenocarcinoma Of Esophagus Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Adenocarcinoma (EAC) Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma (ESCC) Gastro-esophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kappa Santé, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab + chemotherapy

Drug

As prescribed by the treating clinician, as per product label

Primary outcomes

  1. Overall survival (OS)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

Secondary outcomes

  1. Cause of death (where available)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  2. 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

  3. Progression-free survival (PFS)

    Time frame: Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36

  4. Time to treatment discontinuation (TTD)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  5. Time to failure of strategy (TFS)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  6. Time to next Treatment (TTNT)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  7. Second progression-free survival (PFS2)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  8. Treatment Free Interval (TFI)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  9. Overall tumor response (ORR)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  10. Response rate

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  11. Duration of response (DOR)

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  12. Participant socio-demographics

    Time frame: Baseline

  13. Participant clinical characteristics

    Time frame: Baseline

  14. Participant treatment history

    Time frame: Baseline

  15. Nivolumab treatment regime

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  16. Chemotherapy treatment regime

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  17. Reason for treatment discontinuation

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  18. 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

  19. 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

  20. Subsequent systemic treatment effectiveness

    Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36

  21. Participant adverse events (AEs)

    Time frame: Up to 3 years

  22. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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]

Acronym: METAGIO

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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