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

Source: https://onco.cc/trials/nct05663775/  
OnCo record `nct05663775` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial in colorectal cancer, run by AHS Cancer Control Alberta, now recruiting.

## Summary

Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo) is a phase 2, interventional study registered as NCT05663775 by AHS Cancer Control Alberta, with a registry enrolment figure of 20 participants, started 2024-08-20 and due to reach its primary completion in 2026-08. Interventions recorded: Mesalamine. Conditions listed: Immune-related Adverse Event; Diarrhea; Advanced Melanoma; Advanced Rectal Carcinoma. Primary outcome: Incidence of Treatment Related Diarrhea; Severity of Treatment Related Diarrhea; Causality of Treatment Related Diarrhea. Colorectal eligibility wording from the registry: "WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal". Sites: Canada. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Also known as: IMPACT 1
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT05663775
- Phase: 2
- Setting: Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab
- Sponsor: AHS Cancer Control Alberta
- Enrolled: 20

## Sources

- ClinicalTrials.gov NCT05663775: https://clinicaltrials.gov/study/NCT05663775

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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