8951-0305

A Phase 3, Double-Blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) for the first-line treatment of locally advanced, unresectable, or metastatic gastric or gastroesophageal adenocarcinoma in participants whose tumors are HER2-negative, Claudin (CLDN) 18.2-positive, and whose combined positive scores (CPS) are greater than or equal to 1.


Principal Investigator

Dott.ssa Virginia Quarà


Contact Information for Access


Phase

FASE III


Status

ATTIVO




Objective of the study

To evaluate the efficacy of zolbetuximab plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) compared with placebo plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) (as first-line treatment).


Pathologies

Gastrointestinal tumor (GI tumor)


Medication

Zolbetuximab in combination with pembrolizumab + (CAPOX or mFOLFOX6)


Who is eligible to participate in the study?

Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
Patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (HER2-negative, Claudin (CLDN) 18.2-positive, and with a Combined Positive Score (CPS) of 1 or higher) who have not received any prior treatment.


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