Phase II Study of EXL01 With Nivolumab and FOLFOX as First Treatment for Advanced Gastric Cancer Patients With PD-L1 CPS 5 or Higher

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining EXL01 with nivolumab and FOLFOX as a first treatment for patients with advanced gastric cancer who have a PD-L1 combined positive score CPS of 5 or higher. This phase II multicenter study randomly assigns patients to either the experimental group receiving EXL01 with nivolumab and FOLFOX or a control group receiving just nivolumab and FOLFOX. The study aims to measure how well the cancer responds to these treatments at 4 months using established tumor evaluation criteria. Patients in the experimental group receive nivolumab 240 mg intravenously every two weeks, FOLFOX chemotherapy every two weeks, and take EXL01 orally once daily starting on the first day of each treatment cycle. Those in the control group receive nivolumab and FOLFOX without EXL01. Treatment continues until the cancer progresses, unacceptable side effects occur, or for a maximum of 24 months up to 52 cycles. The study plans to enroll 120 patients, with twice as many assigned to the experimental group. During the study, participants undergo regular CT or MRI scans to assess tumor response, blood tests to monitor health and organ function, and safety evaluations for up to 3 years after starting treatment. Researchers will track outcomes such as overall survival, progression-free survival, duration of response, and safety. Patients will be followed closely with scheduled visits and laboratory tests to monitor treatment effects and side effects throughout the study period.

First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer