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

This is a randomized non-comparative, multicenter phase II study in patients with PD-L1 PD-L1 combined positive score (CPS) ≥5 advanced gastric cancer to evaluate the efficacy and safety of nivolumab and FOLFOX in combination with EXL01 as first-line treatment. After signing the informed consent form, and upon confirmation of the patient's eligibility, patients will be randomized in a 2:1 ratio to either the nivolumab and FOLFOX plus EXL01 arm (experimental) or the nivolumab and FOLFOX arm (control). In both arms, treatment will be given until PD, unacceptable toxicity or for a maximum of 24 months (52 cycles).

NCT Number	NCT06253611
Lead Sponsor	GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions	Gastric Cancer
Enrollment	120 participants
Start Date	2024-04-16
Primary Completion	2027-09 (estimated)
Study Completion	2029-04 (estimated)
Updated on ClinicalTrials.gov	2025-09-22