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RecruitingNCT06504615

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

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]

Sponsor

Bristol-Myers Squibb

Enrollment

500 participants

Start Date

Dec 10, 2024

Study Type

OBSERVATIONAL

Conditions

Gastric AdenocarcinomaEsophageal Squamous Cell Carcinoma (ESCC)Gastro-esophageal Junction AdenocarcinomaEsophageal Adenocarcinoma (EAC)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

Interventions

DRUGnivolumab + chemotherapy

As prescribed by the treating clinician, as per product label

Locations(2)

KAPPA SANTE Institution

Paris, France

Kappa Santé

Paris, France

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NCT06504615

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