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

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
Headshot of Hope Elizabeth Uronis
Associate Professor of Medicine
Protocol Number
IRB: PRO00117684
NCT: NCT06901531
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF
More Information