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Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)

Study acronym: IMPACT 1
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 27, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Mar 2025 to Aug 2026
    • Study completion date: Oct 2025 to Aug 2027
    • Start date changed from estimate of Dec 2024 to Aug 20, 2024
    • Site details revised
  2. Start date: Apr 2023 to Dec 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study team's principal interest is to address the question, "Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?"
Trial Details
NCT Number NCT05663775
Lead Sponsor AHS Cancer Control Alberta
Conditions
(from sponsor)		 Immune-related Adverse Event, Diarrhea, Advanced Melanoma, Advanced Rectal Carcinoma
Related terms Diarrhea
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov