Observational study of nivolumab and chemotherapy for advanced gastric and esophageal cancers 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]
This study looks at how well nivolumab combined with chemotherapy helps adults with advanced stomach and esophageal cancers live longer after starting treatment in France.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | nivolumab, chemotherapy |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06504615 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the overall survival of adult patients treated with nivolumab in combination with chemotherapy as a first-line treatment for advanced or metastatic gastric and gastroesophageal junction cancers in France. Participants must have received this treatment prior to joining the study, and the study will analyze real-life outcomes in this patient population. The focus is on patients with specific tumor characteristics, including PD-L1 expression levels.
Who should consider this trial
Good fit: Ideal candidates include adults with untreated advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, esophageal adenocarcinoma, or esophageal squamous cell carcinoma who have specific PD-L1 expression levels.
Not a fit: Patients with primary diagnoses of cancers other than advanced or metastatic gastric or esophageal cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of nivolumab combined with chemotherapy, potentially improving treatment strategies for patients with advanced gastric and esophageal cancers.
How similar studies have performed: Other studies have shown promising results with similar approaches using nivolumab in combination with chemotherapy for these types of cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris and 1 other locations
- KAPPA SANTE Institution — Paris, France (Recruiting)
- Kappa Santé — Paris, France (Not_yet_recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.