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

Study acronym: BIG
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 38 to 37v5 Show 4 more changesShow less
    • Primary completion date: Apr 2027 to Sep 2027
    • Study completion date: Dec 2029 to Apr 2029
    • Secondary endpoints: details revised at 5 of 7 entries
    • Study description expanded, about 1 word
  2. Primary completion date: Mar 2026 to Apr 2027v4 Show 5 more changesShow less
    • Study sites: 18 to 38
    • Study completion date: Mar 2029 to Dec 2029
    • Start date changed from estimate of Jul 2024 to Apr 16, 2024
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 8 to 7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2024 to Jul 2024
    • Study sites: 0 to 18
    v3
  4. Study title shortened, about 10 wordsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06253611
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions
(from sponsor)		 Gastric Cancer
Related terms Stomach Neoplasms
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov