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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?

We are doing this study to find out if a drug called zolbetuximab, when it is combined with pembrolizumab and standard chemotherapy, is a safe and effective option for treating stomach cancer.

What is the Condition Being Studied?

Gastric or Gastroesophageal Junction Adenocarcinoma (Stomach Cancer)

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.

Age Group

Adults

What is Involved?

If you choose to join this study, you will:

Get intravenous (IV) infusions of either zolbetuximab or a placebo (inactive substance with no drug in it) every 2 or 3 weeks
Get IV infusions of pembrolizumab every 3 or 6 weeks
Get FOLFOX or CAPOX chemotherapy every 2 or 3 weeks
Have blood draws and give urine samples
Have regular CT or MRI scans

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