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zolbetuximab plus pembrolizumab and chemotherapy for gastric cancer (8951-CL-0305) - Clinical Trial

or email

gi-oncology-cru@dm.duke.edu

What is the Purpose of this Study?

Estamos realizando este estudio para determinar si un medicamento llamado zolbetuximab, cuando se combina con pembrolizumab y quimioterapia estándar, es una opción segura y eficaz para tratar el cáncer de estómago.

What is the Condition Being Studied?

Adenocarcinoma gástrico o de la unión gastroesofágica (cáncer de estómago)

Who Can Participate in the Study?

Adults ages 18+ who:

Are diagnosed with advanced or metastatic stomach cancer
Have the following document features to their diagnosis: CLDN18.2 positive, PD-L1 positive, and HER2 negative
Have not received any previous treatment for their cancer

For more information, contact the study team at justinemae.flores@duke.edu.

Grupo etario

Adultos

What is Involved?

Si elige unirse a este estudio, podrá:

Reciba infusiones intravenosas (IV) de zolbetuximab o un placebo (sustancia inactiva sin fármaco) cada 2 u 3 semanas
Reciba infusiones intravenosas de pembrolizumab cada 3 u 6 semanas
Reciba quimioterapia FOLFOX o CAPOX cada 2 u 3 semanas
Hacer extracciones de sangre y dar muestras de orina
Realice tomografías computarizadas o resonancias magnéticas de manera regular.

Study Details

Full Title

[8951-CL-0305] A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive

Principal Investigator