Informations générales (source: ClinicalTrials.gov)
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]
Observational
Bristol-Myers Squibb (Voir sur ClinicalTrials)
décembre 2024
août 2028
13 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | ASSOUAD Sabine | 18/09/2025 17:50:08 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Kappa Santé - Paris - France | Contact (sur clinicalTrials) | ||||
| KAPPA SANTE Institution - 75002 - Paris - France | Nathalie Texier, Site 0001 | Contact (sur clinicalTrials) | |||
Critères
Tous
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%
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%
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