Trial Profile

Gut Microbiome Intervention With EXL01 in Combination With Nivolumab and FOLFOX as First-line Treatment for Patients With PD-L1 CPS ≥5 Metastatic Gastric Cancer: A Randomized GERCOR Phase II Study (BIG)

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 14 Oct 2025

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At a glance

Drugs EXL-01 (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Nivolumab (Primary) ; Oxaliplatin (Primary)
Indications Adenocarcinoma; Carcinoma; Gastric cancer; Oesophageal cancer
Focus Therapeutic Use
Acronyms BIG

22 Sep 2025 Planned End Date changed from 1 Dec 2029 to 1 Apr 2029.
22 Sep 2025 Planned primary completion date changed from 1 Apr 2027 to 1 Sep 2027.
17 Jun 2025 Planned End Date changed from 1 Mar 2029 to 1 Dec 2029.

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