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Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.

Study acronym: PREMICES
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Start date: Apr 2025 to Sep 2025v3
  2. Start date: Dec 2024 to Apr 2025v2 Show 10 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 64 to 60
    • Primary completion date: Oct 2027 to Dec 2027
    • Study completion date: Oct 2029 to Dec 2029
    • Interventions: Adjuvant chemotherapy (Drug), Pembrolizumab 200mg IV q3w day 1 of 21-day cycle (Drug), Surgery (Procedure), Watch-and-wait approach… to Adjuvant chemotherapy (Drug), Pembrolizumab Injection [Keytruda] (Drug), Surgery (Procedure), Watch-and-wait approach (Procedure)
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints revised (8)
    • Site contacts updated at 8 of 10 sites
    • Study title shortened, about 8 words
    • Study description expanded, about 3 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair / high microsatellite instability (dMMR/MSI-H) colorectal cancer (CRC). The PREMICES trial is based on the hypothesis that non-operative management is effective for dMMR/MSI-H localized CRC when treated with neoadjuvant pembrolizumab. Eligible patients will be randomized in a 1:1 ratio to receive either pembrolizumab with a watch-and-wait approach (experimental arm A) or the standard strategy of surgical resection ± adjuvant chemotherapy (arm B).
Trial Details
NCT Number NCT06646445
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: Fondation ARCAD
Conditions
(from sponsor)		 Colon Cancer
Related terms Colonic Neoplasms, Microsatellite Instability, Turcot syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov