Actively Recruiting
First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer
Led by GERCOR - Multidisciplinary Oncology Cooperative Group · Updated on 2025-09-22
120
Participants Needed
37
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide signed informed consent before any study procedures.
- Patients must be willing and able to follow study visits, treatment schedules, and tests.
- Diagnosis of inoperable, advanced, or metastatic gastric cancer, gastroesophageal junction, or distal esophageal adenocarcinoma.
- PD-L1 combined positive score (CPS) of 5 or higher confirmed locally and centrally.
- No prior systemic treatment for advanced or metastatic disease; prior neoadjuvant/adjuvant therapy allowed if completed at least 6 months earlier.
- At least one measurable tumor lesion by CT or MRI according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Adequate blood counts and organ function within 14 days before starting treatment.
- Corrected QT interval ≤450 msec for males and ≤470 msec for females.
- Availability of tumor tissue samples for research.
- Registered in a national health care system.
- Age 18 years or older.
- Women not pregnant or breastfeeding and agreeing to contraception as required.
- Fertile males agreeing to contraception and refraining from sperm donation as required.
You will not qualify if you...
- Known HER-2 positive or unknown HER-2 status.
- Active brain metastases or history of leptomeningeal carcinomatosis.
- Uncontrollable ascites.
- Prior malignancy within 3 years except certain locally cured cancers.
- Active or suspected autoimmune diseases except certain controlled conditions.
- Symptomatic interstitial lung disease.
- Prior treatment with immune checkpoint inhibitors or similar therapies.
- Need for systemic corticosteroids >10 mg prednisone equivalent within 14 days before randomization.
- Persistent toxicity grade >1 from prior cancer treatments.
- Major surgery within 28 days before treatment start without full recovery.
- Use of unplanned antitumor therapies during the study.
- Gastrointestinal obstruction, poor oral intake, or swallowing difficulties.
- Known gastrointestinal malabsorption.
- Participation in another investigational study within 28 days before treatment.
- Prior allogeneic bone marrow or solid organ transplantation.
- Fecal microbiota transplant within 3 months prior to screening.
- Current or planned probiotics use during treatment.
- Excessive alcohol intake beyond defined moderate limits.
- Known allergies to study drugs or components.
- Recent or active gastrointestinal parasitic infection.
- Active inflammatory or serious chronic intestinal diseases.
- Active or chronic hepatitis B, C, or HIV infections unless controlled as specified.
- Use of live vaccines within 28 days before randomization or during study.
- Ongoing use of antiviral drugs sorivudine or related agents.
- Dihydropyrimidine dehydrogenase deficiency.
- Any condition interfering with study evaluation or safety.
- Peripheral sensory neuropathy with functional impairment.
- Clinically significant active heart disease or recent myocardial infarction.
- Known hypersensitivity to 5-FU, oxaliplatin, leucovorin, or their excipients.
- Inability to comply with medical follow-up due to social, geographical, or psychiatric reasons.
- Under legal protection or incapable of giving consent.
AI-Screening
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Trial Site Locations
Total: 37 locations
1
Institut de Cancerologie de L'Ouest Paul Papin
Angers, France
Not Yet Recruiting
2
Clinique Sainte Catherine
Avignon, France
Actively Recruiting
3
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France
Actively Recruiting
4
Institut Bergonie
Bordeaux, France
Not Yet Recruiting
5
Centre Hospitalier Universitaire Morvan
Brest, France
Not Yet Recruiting
6
Centre Francois Baclesse
Caen, France
Not Yet Recruiting
7
Centre Hospitalier de Cholet
Cholet, France
Actively Recruiting
8
Centre Hospitalier Universitaire Clermont Ferrand - Site Estaing
Clermont-Ferrand, France
Not Yet Recruiting
9
Centre Hospitalier Henri Mondor
Créteil, France
Not Yet Recruiting
10
Centre Georges Francois Leclerc
Dijon, France
Actively Recruiting
11
Centre Hospitalier Universitaire Grenoble Alpes - Site Nord - Hopital Michallon
La Tronche, France
Not Yet Recruiting
12
Centre Hospitalier Universitaire de Lille
Lille, France
Actively Recruiting
13
Hopital Leon Berard
Lyon, France
Actively Recruiting
14
Hopital Prive Jean Mermoz
Lyon, France
Not Yet Recruiting
15
Hopital La Timone
Marseille, France
Not Yet Recruiting
16
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Not Yet Recruiting
17
Centre Hospitalier Universitaire Nantes - Hopital Hotel Dieu
Nantes, France
Not Yet Recruiting
18
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
19
Centre Hospitalier Cochin
Paris, France
Not Yet Recruiting
20
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France
Not Yet Recruiting
21
Hopital Europeen Georges Pompidou
Paris, France
Not Yet Recruiting
22
Hopital Saint Antoine
Paris, France
Actively Recruiting
23
Hopital Saint-Louis
Paris, France
Not Yet Recruiting
24
Institut Curie
Paris, France
Not Yet Recruiting
25
Institut Gustave Roussy
Paris, France
Not Yet Recruiting
26
Institut Mutualiste Montsouris
Paris, France
Not Yet Recruiting
27
Centre Hospitalier Universitaire de Poitiers - Hopital de La Miletrie
Poitiers, France
Actively Recruiting
28
Centre Hospitalier Universitaire Reims Hopital Robert Debre
Reims, France
Actively Recruiting
29
Institut Jean Godinot
Reims, France
Not Yet Recruiting
30
Centre Hospitalier Universitaire de Rennes
Rennes, France
Not Yet Recruiting
31
Hopital D'Instruction Des Armées Bégin
Saint-Mandé, France
Not Yet Recruiting
32
Centre Hospitalier Saint-Malo
St-Malo, France
Not Yet Recruiting
33
Institut de Cancerologie Strasbourg Europe
Strasbourg, France
Not Yet Recruiting
34
Centre Hospitalier Universitaire Tours - Hopital Trousseau
Tours, France
Not Yet Recruiting
35
CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE NANCY Site Brabois
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
36
Hopital Paul Brousse
Villejuif, France
Actively Recruiting
37
Medipole Hopital Mutualiste Lyon-Villeurbanne
Villeurbanne, France
Not Yet Recruiting
Research Team
M
Marie-Line GARCIA LARNICOL, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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