{"entity":{"id":"nct05663775","kind":"trial","name":"Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)","aka":["IMPACT 1"],"tldr":"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.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05663775","url":"https://clinicaltrials.gov/study/NCT05663775"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","participation":[{"nct":"NCT05663775","source":"https://clinicaltrials.gov/study/NCT05663775","fetchedAt":"2026-10-07T16:53:49.617Z","studySha256":"e4bb2259a631f336eb10570154b5004d68cf14f5983993e54e6cddb97b151e1c","overallStatus":"RECRUITING","lastUpdatePosted":"2025-06-27","leadSponsor":"AHS Cancer Control Alberta","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":20,"enrolmentType":"ESTIMATED","siteCount":1,"recruitingSiteCount":1,"countries":["Canada"]}],"started":"2024-08-20","startedType":"actual","enrolled":20,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05663775/","neighbours":{"cancer":[{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}