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

RECRUITINGSponsored by Bristol-Myers Squibb
Actively Recruiting
SponsorBristol-Myers Squibb
Started2024-12-10
Est. completion2028-08-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06504615

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

CancerEsophageal Adenocarcinoma (EAC)Esophageal Squamous Cell Carcinoma (ESCC)Gastric AdenocarcinomaGastro-esophageal Junction Adenocarcinoma

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