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

The goal of this research study is to test a new study treatment for a specific type of stomach cancer. It is focused on people whose tumors are CLDN18.2 positive, PD-L1 positive, and HER2 negative. This new study treatment has 3 parts:

1. A study drug called zolbetuximab
2. Another study drug called pembrolizumab
3. Standard chemotherapy (mFOLFOX6 or CAPOX)

The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.

For more information, visit: https://clinicaltrials.gov/study/NCT06901531

Inova Schar Cancer
8081 Innovation Park Drive
Fairfax, VA  22031
 

• You are at least 18 years old when you sign this Informed Consent Form
• Within 28 days before you're assigned to a study treatment group in this study, a doctor has confirmed by imaging tests (like X-rays, CT scans, or MRIs) that your stomach cancer either:
  1. Has grown into nearby tissues but hasn't spread to distant parts of the body (called locally advanced)
  2. Cannot be completely removed by surgery (called unresectable), or
  3. Has spread from where it started to other parts of your body (called metastatic)
• Your confirmed stomach cancer is called either "gastric adenocarcinoma" or "GEJ adenocarcinoma"
• You can do daily activities with little or no help, which is sometimes referred to as Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

You will NOT be able to take part in this study if you:
• Have had a severe allergic reaction to any known ingredients of the study drugs
• Have a serious health condition that could affect your safety during study treatment, according to the study team
• Have taken any other investigational drugs in the 28 days (or another time-period depending on the investigational drug) before joining the study. 

Please discuss any investigational drugs you may have taken with the study team.