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

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT06253611
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab 240 mg IV; every 2 weeks
  • FOLFOX regimen — DRUG
    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
  • EXL01 — BIOLOGICAL
    Orally 1 capsule/day, starting on day 1 of each FOLFOX/nivolumab treatment.

Study Details

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).

Key Dates

Start date
Apr 16, 2024
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Objective response rate (ORR) at 4 months [ Time Frame: At 4 months ]

Central Contacts

Related Studies