Plain-English translation of NCT05663775 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing whether , an anti-inflammatory medication, can help prevent a common and sometimes serious side effect called immune-related colitis (severe diarrhea and bowel inflammation) that occurs in some patients receiving combination immunotherapy (ipilimumab and nivolumab) for advanced melanoma or rectal cancer. The medication is taken by mouth four times a day alongside standard cancer treatment. Researchers hope this preventive approach will keep patients more comfortable and allow them to continue their cancer therapy without interruption.
Combination immunotherapy is an effective treatment for advanced melanoma and rectal cancer, but it can cause severe diarrhea and bowel inflammation in many patients, sometimes forcing doctors to pause or stop treatment. This trial aims to see whether taking this medication in advance can reduce how often and how severe these bowel problems become, helping more patients tolerate their cancer treatment.
You likely qualify if…
You likely don't qualify if…
If you join this trial, you will take pills (500 mg) by mouth four times daily while receiving your standard immunotherapy treatment. You will attend regular clinic visits to check your health, report any side effects (especially bowel symptoms), and have blood tests to monitor your organ function. The study will track whether you develop diarrhea or bowel inflammation and how severe it is, comparing your experience to what typically happens with this cancer treatment alone.
AI-generated summary from trial data · Jun 12, 2026 · Not medical advice
Canada
Phase
Testing effectiveness
Sponsor
AHS Cancer Control Alberta
Enrollment target
~20 participants
Started
August 2024
Primary completion
August 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years and older
Last updated on clinicaltrials.gov in June 2025.
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.