Status:
RECRUITING
Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Gastric Adenocarcinoma
Gastro-esophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
Brief 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 gastroe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06504615
Start Date
December 10 2024
End Date
August 31 2028
Last Update
December 13 2024
Active Locations (2)
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1
KAPPA SANTE Institution
Paris, France, 75002
2
Kappa Santé
Paris, France