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Gastric CancerPhase 2BIGNCT06253611

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

A Phase 2 study testing Nivolumab, FOLFOX regimen and EXL01 in people with Gastric Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 37 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Nivolumab, FOLFOX regimen and EXL01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
37 sitesFrance
Study dates
16 Apr 2024to Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have dated and signed an approved written informed consent form. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care.
  • Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study,
  • Target Population
  • Inoperable, advanced, or metastatic gastric cancer or gastroesophageal junction or distal esophageal carcinoma and histologically confirmed predominant adenocarcinoma,
  • Expression of PD-L1 with a combined positive score (PD-L1 CPS) ≥5, Note: information must be available at the time of inclusion, the examination will be performed locally in the center and secondarily confirmed centrally,
  • No prior systemic cancer treatment given as primary therapy for advanced nonresectable or metastatic disease, Note: if patient received neoadjuvant/adjuvant therapy, this therapy should be completed at least 6 months prior to the diagnosis of metastatic or recurrent disease is made. Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization,
Show all 31Show fewer
  • At least one measurable lesion as assessed by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and feasibility of repeated radiological assessments; radiographic tumor assessment should be performed within 28 days prior to randomization,
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1,
  • Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization of study treatment:
  • White blood cell ≥ 2000/μL;
  • Neutrophils ≥ 2000/μL;
  • Platelets ≥ 100.000/μL;
  • Hemoglobin ≥ 9.0 g/dL;
  • Serum albumin ≥ 30 g/L;
  • Serum creatinine level ≤ 150 μM and calculated creatinine clearance (Cockcroft-Gault) > 50 mL/minute,
  • Total bilirubin ≤ 1.5 x upper normal limit (ULN);
  • Alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present);
  • Aspartame aminotransferase (AST) ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present);
  • Potassium ≥ 1.0 x lower limit of normal (LLN),
  • Magnesium ≥ 1.0 x LLN,
  • Calcium ≥ 1.0 x LLN,
  • Baseline-corrected QT interval ≤ 450 msec for males and ≤ 470 msec for females,
  • Availability of a representative tumor tissue specimen for exploratory translational research; tumor tissue samples, either formalin- fixed paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections (minimum of 20 positively charged slides) from primary or metastatic site must be submitted to the central laboratory,
  • Registration in a national health care system (PUMa-Protection Universelle Maladie included.
  • Age and reproductive status
  • Age ≥ 18 years,
  • Women must not be pregnant, breastfeeding, or expecting to conceive during the study,
  • Reproductive status:
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the start of study drug,
  • WOCBP must agree to use an adequate method of contraception or birth control for the duration of study treatment and 5 months (nivolumab), 9 months (oxaliplatin), 6 months (5-FU) or at least 1 month (EXL01) of the patient's last dose of the study drug,
  • Males who are fertile and sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment and 6 months (nivolumab, oxaliplatin, or 5-FU) or at least 1 month (EXL01) after the last dose of study treatment. In addition, males must be willing to refrain from sperm donation during this time,

Who cannot join

  • Target Disease Exceptions
  • Known HER-2 positive status or unknown HER-2 status before inclusion,
  • Active brain metastases or known history of leptomeningeal carcinomatosis,
  • Ascites, which cannot be controlled with appropriate interventions,
  • Exclusion criteria related to medical history and concurrent disease
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast,
Show all 47Show fewer
  • Active, known, or suspected autoimmune disease; type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted,
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity,
  • Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co- stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents,
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days (2 weeks) of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted prior to randomization in the absence of active autoimmune disease,
  • Persistence of toxicity (The National Cancer Institute Common Terminology Criteria for Adverse Event [NCI CTCAE] v 5.0) grade >1 related to prior anticancer treatments,
  • Major surgery within 28 days (4 weeks) prior to first dose of study treatment, Note: Participants who had surgery >4 weeks prior to screening must have recovered adequately from any toxicity and/or complications from the surgery or trauma prior to starting study intervention.
  • Concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy),
  • GI obstruction, poor oral intake, or difficulty in taking oral medication or difficulties in swallowing; nasogastric tubes are not permitted,
  • Known GI malabsorption,
  • Is currently participating in or has participated in a study with an investigational compound within 28 days prior to the first dose of study treatment, Note: Participants who have entered the follow-up phase of an investigational study may participate so long as it has been at least 3 months since the last dose of the previous investigational agent,
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
  • Fecal microbiota transplant within 3 months prior to screening, Note: Patients must have recovered adequately from the toxicity and/or complications from the treatment prior to starting study intervention.
  • Current probiotics administration, or planned probiotics administration during treatment course is not allowed, Note: The following therapies should be avoided during the study; however, they are not prohibited if, in the assessment of the
  • Investigator, they are required for clinical management:
  • Nonsteroidal anti-inflammatories,
  • Antacids,
  • Proton-pump inhibitors.
  • Excessive alcohol intake: moderate consumption, defined as no more than 1 drink per day for women and no more than 2 drinks per day for men, is permitted,
  • Known allergy and/or hypersensitivity to any component or excipients of study treatments (nivolumab, EXL01), any other live pro- biotherapeutic product, and/or to soybean or soy-containing products,
  • Known history or newly diagnosed GI parasitic infection within 3 months prior to screening, Note: Patients must have recovered adequately from the toxicity and/or complications from the treatment prior to starting study intervention,
  • Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea, or other inflammatory disease requiring anti-inflammatory medications (according to exclusion criteria n°8),
  • Active or chronic hepatitis B virus (HBV), hepatitis C virus (HCV) and/or human immunodeficiency virus infection (HIV 1/2 antibodies).
  • Participants are eligible if they:
  • Have controlled HCV load defined as undetectable hepatitis C RNA by polymerase chain reaction either spontaneously or in response to a successful prior course of anti-hepatitis C therapy,
  • Have received HBV vaccination with only anti-HBs positivity and no clinical signs of hepatitis,
  • Are HBV surface antigen (HBsAg)- and anti- Hepatitis B core antibody (HBc)+ (i.e., those who have cleared HBV after infection),
  • Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions below:
  • HBV DNA viral load <100 IU/mL,
  • Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of AST/ALT <3 × ULN, which are not attributable to HBV infection,
  • Start or maintain antiviral treatment if clinically indicated as per the investigator,
  • Any (attenuated) live vaccine use within 28 days (4 weeks) prior to randomization, while in the study; live vaccines include, but are not limited to, the following: yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza,
  • Ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine,
  • Dihydropyrimidine dehydrogenase deficiency (DPD; uracilemia dosage >16 ng/ml), Uracilemia dosing results must be available before inclusion,
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results,
  • Known peripheral sensory neuropathy with functional impairment according exclusion criteria n°9) prior to first treatment, according to the Summary of product characteristics (SmPC) of oxaliplatin,
  • Known potentially serious infection, according to the SmPC of 5-FU
  • Has clinically significant active heart disease or myocardial infarction within 6 months given the cardiotoxicity of 5-FU, according to the SmPC of 5-FU,
  • Known history of hypersensitivity to 5-FU, oxaliplatin, or leucovorin, or to any of their excipients, according to the SmPCs of these products.
  • Exclusion criteria related to geographical, social, and legal issues
  • Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness,
  • Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent.

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marie-Line GARCIA LARNICOL, MD contact

+33 (01) 40 29 85 04

marie-line.garcia-larnicol@gercor.com.fr

37 sites in 1 country

France37 sites, 37 recruiting

  • Institut de Cancerologie de L'Ouest Paul Papin

    Angers

    Sandrine HIRET, MD

    Not yet recruiting

  • Clinique Sainte Catherine

    Avignon

    Clemence TOULLEC, MD

    Recruiting

  • Centre Hospitalier Universitaire Jean Minjoz

    Besançon

    Angelique VIENOT, MD

    Recruiting

  • Institut Bergonie

    Bordeaux

    Simon PERNOT, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire Morvan

    Brest

    Estelle Dhamelincourt, MD

    Not yet recruiting

  • Centre Francois Baclesse

    Caen

    Aurélie PARZY, MD

    Not yet recruiting

  • Centre Hospitalier de Cholet

    Cholet

    Thonas CENTRE HOSPITALIER DE CHOLET, MD

    Recruiting

  • Centre Hospitalier Universitaire Clermont Ferrand - Site Estaing

    Clermont-Ferrand

    Marine JARY, MD

    Not yet recruiting

  • Centre Hospitalier Henri Mondor

    Créteil

    Charlotte Fenioux, MD

    Not yet recruiting

  • Centre Georges Francois Leclerc

    Dijon

    Francois GHIRINGHELLI, MD

    Recruiting

  • Centre Hospitalier Universitaire Grenoble Alpes - Site Nord - Hopital Michallon

    La Tronche

    Gaël ROTH, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Lille

    Lille

    Anthony TURPIN, MD

    Recruiting

  • Hopital Leon Berard

    Lyon

    Clelia COUTZAC, MD

    Recruiting

  • Hopital Prive Jean Mermoz

    Lyon

    Pascal ARTRU, MD

    Not yet recruiting

  • Hopital La Timone

    Marseille

    Laëtitia DAHAN, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier

    Eric ASSENAT, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire Nantes - Hopital Hotel Dieu

    Nantes

    Tamara MATYSIAK-BUDNIK, MD

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice

    Ludovic Evesque, MD

    Recruiting

  • Centre Hospitalier Cochin

    Paris

    Anna PELLAT, MD

    Not yet recruiting

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris

    Olivier DUBREUIL, MD

    Not yet recruiting

  • Hopital Europeen Georges Pompidou

    Paris

    Aziz Zaanan, MD

    Not yet recruiting

  • Hopital Saint Antoine

    Paris

    Romain COHEN, MD

    Recruiting

  • Hopital Saint-Louis

    Paris

    Thomas APARICIO, MD

    Not yet recruiting

  • Institut Curie

    Paris

    Cindy NEUZILLET, MD

    Not yet recruiting

  • Institut Gustave Roussy

    Paris

    Cristina SMOLENSCHI, MD

    Not yet recruiting

  • Institut Mutualiste Montsouris

    Paris

    Emilie SOULARUE, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Poitiers - Hopital de La Miletrie

    Poitiers

    David TOUGERON, MD

    Recruiting

  • Centre Hospitalier Universitaire Reims Hopital Robert Debre

    Reims

    Olivier BOUCHE, MD

    Recruiting

  • Institut Jean Godinot

    Reims

    Damien BOTSEN, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Rennes

    Rennes

    Astrid LIEVRE, MD

    Not yet recruiting

  • Hopital D'Instruction Des Armées Bégin

    Saint-Mandé

    Julie LAVOLE, MD

    Not yet recruiting

  • Centre Hospitalier Saint-Malo

    St-Malo

    Romain DESGRIPPES, MD

    Not yet recruiting

  • Institut de Cancerologie Strasbourg Europe

    Strasbourg

    Meher BEN ABDELGHANI, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire Tours - Hopital Trousseau

    Tours

    Elise DOUARD TOURNET, MD

    Not yet recruiting

  • CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE NANCY Site Brabois

    Vandœuvre-lès-Nancy

    Marie MULLER, MD

    Not yet recruiting

  • Hopital Paul Brousse

    Villejuif

    Pascal Hammel, MD

    Recruiting

  • Medipole Hopital Mutualiste Lyon-Villeurbanne

    Villeurbanne

    Mathieu SARABI, MD

    Not yet recruiting

Other trials in France

About this study

Official title: 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)

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).

Read the detailed description

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 v1.1) 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.

Conditions
Gastric Cancer
Being tested
Nivolumab, FOLFOX regimen, EXL01
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    Nivolumab 240 mg IV; every 2 weeks

  • FOLFOX regimenDrug

    Also called Leucovorin, fluorouracil, and oxaliplatin

    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

  • EXL01Biological

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

Study groups in NCT06253611
Study groupRoleWhat they receive
Nivolumab Combined With FOLFOX and EXL01ExperimentalNivolumab 240 mg IV q2w and FOLFOX q2w plus EXL01 orally once daily
Receives: Drug: Nivolumab; Drug: FOLFOX regimen; Biological: EXL01
Nivolumab and FOLFOXActive comparatorNivolumab 240 mg IV q2w and FOLFOX q2w
Receives: Drug: Nivolumab; Drug: FOLFOX regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) at 4 months

    ORR measured at 4 months post randomization in patients with PD-L1 CPS ≥5 advanced gastric cancer treated by first-line EXL01 plus nivolumab and FOLFOX. ORR at 4 months is defined as the number of patients with a CR or PR evaluated by RECIST v 1.1 criteria divided by the number of patients evaluable.

    Measured: At 4 months

Secondary outcomes (7)

  1. Overall survival (OS)

    OS with nivolumab plus FOLFOX with or without EXL01. OS is defined as the time between the date of randomization and the date of death from any cause.

    Measured: Maximum 3 years after randomization

  2. Progression-free survival (PFS)

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

    PFS is defined as the time from randomization to the date of the first documented PD determined by the Investigator assessment by RECIST 1.1 or death due to any cause, whichever occurs first.

    Measured: Maximum 3 years after randomization

  3. Assessment of safety profile

    Safety of nivolumab plus FOLFOX with or without EXL01. Safety will be measured by the incidence of Adverse Events (AEs), Serious AEs (SAEs), deaths, laboratory abnormalities, and specific immune-related AEs (hepatitis, colitis, myositis, endocrinopathies).

    Measured: Maximum 3 years after randomization

  4. Duration of response (DoR)

    DoR with FOLFOX plus nivolumab with or without EXL01. DoR is defined as the time between the date of first documented response (complete response [CR] or partial response [PR]) to the date of the first disease progression, per RECIST 1.1 or death due to any cause, whichever occurs first. For patients who neither progress nor die, the duration of objective response will be censored at the same time they were censored for the primary definition of PFS.

    Measured: Maximum 3 years after randomization

  5. Objective response rate (ORR)

    ORR per RECIST v 1.1 criteria nivolumab plus FOLFOX with or without EXL01. ORR is defined as the number of patients with the best overall response (BOR) of CR or PR divided by the number of measurable patients with target lesion at baseline. BOR is defined as the best response designation, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy, whichever occurs first.

    Measured: Maximum 3 years after randomization

  6. 2-year and 3-year OS

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

    Measured: At 2 years and 3 years

  7. 1-year and 2-year PFS

    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

    Measured: At 1 year and at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start16 Apr 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06253611
Sponsor's protocol ID
BIG G-122 PRODIGE 94
Acronym
BIG
Status last verified
Sep 2025
First submitted
31 Jan 2024
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, FOLFOX regimen and EXL01 in people with Gastric Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie-Line GARCIA LARNICOL, MD (+33 (01) 40 29 85 04, marie-line.garcia-larnicol@gercor.com.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) at 4 months (time frame: At 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06253611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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