Trial intelligence / Profile preview

EXL01 + nivolumab + FOLFOX vs nivolumab + FOLFOX in first-line PD-L1 CPS ≥5 metastatic gastric cancer (BIG)

2023-506753-38-00Phase 2Authorised

Sponsor
GERCOR
Start
Jan 2024
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Live Biotherapeutic Products → Microbiome Therapeutics, Small Molecules
Countries
1
01

Overview

Phase 2, randomised trial in gastric adenocarcinoma, Esophago-Gastric Adenocarcinoma and esophageal adenocarcinoma (EAC) comparing EXL01 + nivolumab + FOLFOX with nivolumab + FOLFOX (2 arms). Primary endpoint: Primary ORR at 4 months. Planned start Jan 2024; status: authorised.

02

Drugs

exl01nivolumabFOLFOX
03

Conditions

gastric adenocarcinomaEsophago-Gastric Adenocarcinomaesophageal adenocarcinoma (EAC)

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