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Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

Study acronym: CIME
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 6 to 7v10
  2. Study sites: 5 to 6v9
  3. Study sites: 4 to 5
    • Eligibility criteria expanded, about 12 words
    v8
  4. Study sites: 3 to 4v7
  5. Study sites: 2 to 3v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 2v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2025 to Dec 8, 2025
    • Site details revised
    v4
  3. Start date: Oct 15, 2024 to Dec 15, 2025
    • Enrollment target: 124 to 132
    v3
  4. Start date: May 15, 2024 to Oct 15, 2024v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm).
Trial Details
NCT Number NCT06346197
Lead Sponsor Centre Leon Berard
Collaborators: Agenus Inc.
Conditions
(from sponsor)		 Gastric Cancer, MSI-H, Metastatic Cancer, Advanced Cancer
Related terms Neoplasm Metastasis, Stomach Neoplasms
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov