Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06504615
- Status
- Active Not Recruiting
Conditions
- Esophageal Adenocarcinoma (EAC)
- Esophageal Squamous Cell Carcinoma (ESCC)
- Gastric Adenocarcinoma
- Gastro-esophageal Junction Adenocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- nivolumab + chemotherapy — DRUGAs prescribed by the treating clinician, as per product label
Study Details
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.
Key Dates
- Start date
- Dec 10, 2024
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 208 participants (actual)
Arms
- Arm: Cohort 1Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma
- Arm: Cohort 2Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma
Primary Outcome Measure
Overall survival (OS) [ Time Frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 ]
Related Studies
- Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric CancerPHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
- Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor MalignanciesPHASE2 · Recruiting · Dan Zandberg · Pittsburgh, Pennsylvania
- Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric AdenocarcinomaPHASE2 · Recruiting · University of Wisconsin, Madison · Madison, Wisconsin
- Magnetic Sentinel Lymph Node Mapping in Gastric CancerPHASE1 · Not Yet Recruiting · M.D. Anderson Cancer Center · Houston, Texas