Recruiting PHASE2 INTERVENTIONAL 2-arm NCT06253611

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

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)

Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions Gastric Cancer

Interventions EXL01 FOLFOX regimen Nivolumab

Updated 7 times since 2024 Last updated: Sep 16, 2025 Started: Apr 16, 2024 Primary completion: Sep 30, 2027 Completion: Apr 30, 2029

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Gastric Cancer and is currently actively recruiting participants. GERCOR - Multidisciplinary Oncology Cooperative Group leads this study, which shows 7 recorded versions since 2024 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

7 versions recorded

Oct 2025 — Present [monthly]

Recruiting PHASE2
Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE2
Jul 2025 — Sep 2025 [monthly]

Recruiting PHASE2
Sep 2024 — Jul 2025 [monthly]

Recruiting PHASE2
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting

▶ Show 2 earlier versions

Jul 2024 — Aug 2024 [monthly]

Not Yet Recruiting PHASE2
Mar 2024 — Jul 2024 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GERCOR - Multidisciplinary Oncology Cooperative Group

Data source: GERCOR - Multidisciplinary Oncology Cooperative Group

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Angers, France , Avignon, France , Besançon, France , Bordeaux, France , Brest, France , Caen, France , Cholet, France , Clermont-Ferrand, France , Créteil, France , Dijon, France and 18 more locations