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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Gastro-esophageal Junction Adenocarcinoma; Esophageal Squamous Cell Carcinoma (ESCC); Esophageal Adenocarcinoma (EAC); Gastric Adenocarcinoma

Treatments: Drug: nivolumab + chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT06504615

CA209-1408

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Cohort 1

Description:

Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma

Treatment:

Drug: nivolumab + chemotherapy

Cohort 2

Description:

Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Treatment:

Drug: nivolumab + chemotherapy