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Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

Study acronym: IMHOTEP
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Study sites: 17 to 18
    • Primary completion date changed from estimate of Nov 2025 to Oct 5, 2023
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Enrollment target: 160 to 240v7 Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 11 to 12
    • Study description shortened, about 8 words
    • Study arms: 4 to 3
  5. Primary completion date: Nov 2023 to Nov 2025
    • Study completion date: Oct 2026 to Oct 2029
    v6
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  1. Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: 120 to 160
    • Study sites: 7 to 17
    • Eligibility criteria shortened, about 26 words
    • Study description revised
  2. Study sites: 1 to 7v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2021 to Oct 18, 2021
    • Site details revised
    v3
  4. Start date: May 2021 to Oct 2021
    • Study completion date: Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: 10 to 11
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This trial is a multicenter, 3-cohort, prospective, Phase II trial conducted in patients with untreated resectable MSI/dMMR carcinomas and aiming to evaluate the safety and the efficacy of ICI (immune checkpoint inhibitor) as neoadjuvant treatment in these patients. We hypothesize that immune checkpoint inhibitors (ICPi) will benefit to MSI/dMMR tumors from the early stages, whatever their anatomical origin. We assume that this neoadjuvant treatment would improve the response rate, providing even high rate of pathological complete responses and prolong patients survival. We anticipated colorectal and gastric cancers to be the most frequent recruited and constructed our statistical hypothesis with results in those 2 cancers. However patients with other localized MSI/dMMR tumors could be included.
Trial Details
NCT Number NCT04795661
Lead Sponsor Centre Leon Berard
Conditions
(from sponsor)		 Localized Resectable Tumor, MSI/dMMR
Related terms Neoplasms
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov