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)

Status: Recruiting
Location: See all (37) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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,

• 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,

Locations
Other Locations
France
Institut de Cancerologie de L'Ouest Paul Papin
NOT_YET_RECRUITING
Angers
Clinique Sainte Catherine
RECRUITING
Avignon
Centre Hospitalier Universitaire Jean Minjoz
RECRUITING
Besançon
Institut Bergonie
NOT_YET_RECRUITING
Bordeaux
Centre Hospitalier Universitaire Morvan
NOT_YET_RECRUITING
Brest
Centre Francois Baclesse
NOT_YET_RECRUITING
Caen
Centre Hospitalier de Cholet
RECRUITING
Cholet
Centre Hospitalier Universitaire Clermont Ferrand - Site Estaing
NOT_YET_RECRUITING
Clermont-ferrand
Centre Hospitalier Henri Mondor
NOT_YET_RECRUITING
Créteil
Centre Georges Francois Leclerc
RECRUITING
Dijon
Centre Hospitalier Universitaire Grenoble Alpes - Site Nord - Hopital Michallon
NOT_YET_RECRUITING
La Tronche
Centre Hospitalier Universitaire de Lille
RECRUITING
Lille
Hopital Leon Berard
RECRUITING
Lyon
Hopital Prive Jean Mermoz
NOT_YET_RECRUITING
Lyon
Hopital La Timone
NOT_YET_RECRUITING
Marseille
Centre Hospitalier Universitaire de Montpellier
NOT_YET_RECRUITING
Montpellier
Centre Hospitalier Universitaire Nantes - Hopital Hotel Dieu
NOT_YET_RECRUITING
Nantes
Centre Antoine Lacassagne
RECRUITING
Nice
Centre Hospitalier Cochin
NOT_YET_RECRUITING
Paris
Groupe Hospitalier Diaconesses Croix Saint-Simon
NOT_YET_RECRUITING
Paris
Hopital Europeen Georges Pompidou
NOT_YET_RECRUITING
Paris
Hopital Saint Antoine
RECRUITING
Paris
Hopital Saint-Louis
NOT_YET_RECRUITING
Paris
Institut Curie
NOT_YET_RECRUITING
Paris
Institut Gustave Roussy
NOT_YET_RECRUITING
Paris
Institut Mutualiste Montsouris
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers - Hopital de La Miletrie
RECRUITING
Poitiers
Centre Hospitalier Universitaire Reims Hopital Robert Debre
RECRUITING
Reims
Institut Jean Godinot
NOT_YET_RECRUITING
Reims
Centre Hospitalier Universitaire de Rennes
NOT_YET_RECRUITING
Rennes
Hopital D'Instruction Des Armées Bégin
NOT_YET_RECRUITING
Saint-mandé
Centre Hospitalier Saint-Malo
NOT_YET_RECRUITING
St-malo
Institut de Cancerologie Strasbourg Europe
NOT_YET_RECRUITING
Strasbourg
Centre Hospitalier Universitaire Tours - Hopital Trousseau
NOT_YET_RECRUITING
Tours
CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE NANCY Site Brabois
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Hopital Paul Brousse
RECRUITING
Villejuif
Medipole Hopital Mutualiste Lyon-Villeurbanne
NOT_YET_RECRUITING
Villeurbanne
Contact Information
Primary
Marie-Line GARCIA LARNICOL, MD
marie-line.garcia-larnicol@gercor.com.fr
+33 (01) 40 29 85 04
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2029-04
Participants
Target number of participants: 120
Treatments
Experimental: Nivolumab Combined With FOLFOX and EXL01
Nivolumab 240 mg IV q2w and FOLFOX q2w plus EXL01 orally once daily
Active_comparator: Nivolumab and FOLFOX
Nivolumab 240 mg IV q2w and FOLFOX q2w
Related Therapeutic Areas
Sponsors
Leads: GERCOR - Multidisciplinary Oncology Cooperative Group

This content was sourced from clinicaltrials.gov

Similar Clinical Trials