Phase
Condition
Adenocarcinoma
Digestive System Neoplasms
Gastric Cancer
Treatment
nivolumab + chemotherapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
KAPPA SANTE Institution
Paris, 75002
FranceActive - Recruiting
Kappa Santé
Paris,
FranceSite Not Available
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