Study Details

Open

A Study of Zolbetuximab Together with Pembrolizumab and Chemotherapy in Adults with Gastric Cancer

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 (mFOLFOX or CAPOX) Researchers want to know if this combination is safe and if it works better than current treatments for people living with this specific type of stomach cancer

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will meet with the study team to see if you are eligible to take part in the study. This will include an exam, labs, and imaging. If you are eligible, you may be enrolled in 1 of 2 study treatment groups (A and B) : Study Group A will receive either: • Zolbetuximab + pembrolizumab + chemotherapy (mFOLFOX6, which is a combination of oxaliplatin, leucovorin, and fluorouracil), or • Zolbetuximab+ pembrolizumab + chemotherapy (CAPOX, which is a combination of oxaliplatin and capecitabine) Study Group B will receive either: • Placebo + pembrolizumab + chemotherapy (mFOLFOX6, which is a combination of oxaliplatin, leucovorin, and fluorouracil), or • Placebo + pembrolizumab + chemotherapy (CAPOX, which is a combination of oxaliplatin and capecitabine) This means you will have a 50% chance of being assigned to either group A or B. The assignment is random, which means a computer will assign you to one of the groups by chance, like flipping a coin. After you complete treatment, you will be asked to return to clinic to meet with the study team to see how you are doing. You may also be contacted over the phone.

Incentives

In-person visits:
At least 8 visits, depending on how long you continue on treatment

Phone or online visits:
Survival follow up may be completed by phone every 12 weeks

Total length of participation:
36 months

Looking for Specific Volunteers

Able to participate:

Participant has histologically confirmed gastric or GEJ adenocarcinoma.
Participant has predicted life expectancy ≥ 12 weeks in the opinion of the investigator.
Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization.
Participant agrees not to participate in another interventional study while receiving study intervention in the present study.

Not eligible if:

Participant has prior severe allergic reaction or intolerance to (zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX).
Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis.
Participant has significant gastric bleeding and/or untreated gastric ulcers that would preclude the participant from participation per investigator's judgment.
Participant has a known history of a positive test for HIV infection or known active hepatitis B (positive HBsAg) or hepatitis C infection.
Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.

Contact the Team

Visit Location

Contact & Visit Location

Additional Study Information

Principal Investigator

Ashwin Somasundaram
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Colorectal)

IRB Number

25-0880

ClinicalTrials.gov

NCT06901531