Actively Recruiting
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Led by AHS Cancer Control Alberta · Updated on 2025-06-27
20
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?"
CONDITIONS
Official Title
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older.
- Patients with histologically confirmed, unresectable stage III or IV malignant melanoma.
- Patients must be capable of providing consent to enrolment and treatment.
- Patients with a performance status of ECOG 0-224.
- Women of child bearing potential must have a negative pregnancy test at screening.
- Patients of childbearing potential must use highly effective birth control during treatment and for 30 days after last dose.
- Female patients who are breast-feeding should stop nursing before starting treatment and until 30 days after last dose.
- Male patients should agree not to donate sperm during treatment and for 30 days after last dose.
- Adequate organ function as defined by specific blood counts, kidney function, and liver tests.
You will not qualify if you...
- Active cardiovascular disease such as recent stroke, heart attack, unstable angina, congestive heart failure (Class II or higher), or serious arrhythmia requiring medication.
- Current use of immunosuppressive medications except nasal, inhaled, topical steroids, low-dose systemic corticosteroids, or steroids as premedication.
- Known severe allergy to the study drug or similar monoclonal antibodies.
- Other severe medical conditions or lab abnormalities that increase risk or interfere with the study, as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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