Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Nivolumab

Oxaliplatin

Leucovorin

Fluorouracil

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Nivolumab 240 mg IV q2w and FOLFOX q2w plus EXL01 orally once daily

Oxaliplatin 85 mg/m², leucovorin 400 mg/m², bolus of 5-FU 400 mg/m², continuous 5-FU 2400/m² in 46 hours; every 2 weeks

FOLFOX regimen

Orally 1 capsule/day, starting on day 1 of each FOLFOX/nivolumab treatment.

EXL01

Marie-Line GARCIA LARNICOL, MD

Romain Cohen, MD

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).

The primary objective of the study is to assess the objective response rate (ORR) at 4 months (based on Response Evaluation Criteria in Solid Tumor \[RECIST\] criteria) of patients with PD-L1 CPS ≥ 5 advanced gastric cancer treated by EXL01 plus nivolumab and FOLFOX as first-line treatment.

With a randomization ratio of 2:1 it will be necessary to randomize 40 patients in the control arm, 80 patients in the experimental arm and so a total of 120 evaluable patients in the study. Randomization will be stratified by PD-L1 expression level, center, and prior gastrectomy.

In the experimental arm, the primary analysis will be on modified intent-to-treat (mITT) population. Confirmative analysis will be conducted firstly in the ITT population and secondly, in the Per Protocol (PP). Analyses of safety will be conducted in safety population.

The Kaplan-Meier method will be used to estimate time to event endpoints and described using the median and event-free rates over time with CI.

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

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)

ORR measured at 4 months post randomization

OS with nivolumab plus FOLFOX with or without EXL01

PFS per RECIST v 1.1 and iRECIST of nivolumab plus FOLFOX with or without EXL01

Safety of nivolumab plus FOLFOX with or without EXL01

The incidence of specific immune-related AEs (hepatitis, colitis, myositis, endocrinopathies)

DoR with FOLFOX plus nivolumab with or without EXL01

ORR per RECIST v 1.1 criteria nivolumab plus FOLFOX with or without EXL01.

2-year and 3-year OS rate of nivolumab plus FOLFOX with or without EXL01

1-year and 2-year PFS rates per RECIST v 1.1 and iRECIST (immune RECIST) criteria with nivolumab plus FOLFOX with or without EXL01

Spots Global Cancer Trial Database for exl01

Every month we try and update this database with for exl01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for exl01

Every month we try and update this database with for exl01 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for exl01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.