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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Hope
Uronis
Protocol Number
PRO00117684
NCT ID
NCT06901531
Phase
III
Enrollment Status
Pending Open to Enrollment