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

Last updated: December 12, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Digestive System Neoplasms

Gastric Cancer

Treatment

nivolumab + chemotherapy

Clinical Study ID

NCT06504615
CA209-1408
  • Ages > 18
  • All Genders

Study 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 gastroesophageal junction cancer.

Eligibility Criteria

Inclusion

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- andplatinum-based chemotherapy (according to the French current marketingauthorization) for the treatment of Gastric Adenocarcinoma, Gastro-EsophagealJunction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or EsophagealSquamous 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

Exclusion Criteria:

Cohorts 1 & 2

  • Participants with a primary diagnosis of a cancer other than advanced or metastaticgastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC, within the past 5 years.

  • Participants currently enrolled in an interventional clinical trial for his/heradvanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC.

  • Pregnant women

  • Participants under guardianship

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: nivolumab + chemotherapy
Phase:
Study Start date:
December 10, 2024
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • KAPPA SANTE Institution

    Paris, 75002
    France

    Active - Recruiting

  • Kappa Santé

    Paris,
    France

    Site Not Available

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