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

Trial Details

NCT ID

NCT06253611

Phase

PHASE2

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Status

RECRUITING

Cancer Type

Gastric Cancer

Locations (sample)

Angers, France
Avignon, France
Besançon, France
Bordeaux, France
Brest, France

Key Eligibility Criteria

Patients must have dated and signed an approved written informed consent form. This must be obtained before the performance of any protocol-related…
Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study,
Target Population
Inoperable, advanced, or metastatic gastric cancer or gastroesophageal junction or distal esophageal carcinoma and histologically confirmed predomi…

For full eligibility, visit ClinicalTrials.gov.

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