Actively Recruiting
Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab
Led by AHS Cancer Control Alberta · Updated on 2025-06-27
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether giving mesalamine before and during treatment with the immunotherapy drugs ipilimumab and nivolumab can prevent or reduce immune-related diarrhea. This trial focuses on adults with advanced melanoma, a serious type of skin cancer that is not surgically removable. The study is a Phase 2 clinical trial led by AHS Cancer Control Alberta that aims to understand the impact of mesalamine on diarrhea caused by these immunotherapies. Participants will receive 500 mg of mesalamine four times daily along with their standard immunotherapy treatment of ipilimumab and nivolumab. The study will monitor participants over several treatment cycles, each lasting 3 weeks, for a total of 4 cycles. Monitoring will continue through a post-treatment follow-up period at 12, 18, and 24 weeks to assess ongoing effects. During the study, participants will be regularly assessed for the occurrence, severity, and cause of diarrhea and other immune-related side effects. These assessments will take place at screening, during each treatment cycle, and throughout the follow-up visits. Researchers will also track the use of medications to manage side effects, the timing of side effect onset and resolution, and whether side effects lead to stopping treatment. The total participation duration covers the treatment cycles plus the follow-up period.
CONDITIONS
Brief 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 will be eligible for enrolment.
- Women of child bearing potential must have a negative pregnancy test at screening.
- Patients of childbearing/reproductive potential should use highly effective birth control during treatment and for 30 days after last dose.
- Female patients who are breast-feeding should stop nursing before first dose and until 30 days after last dose.
- Male patients should agree not to donate sperm during the study and for 30 days after last dose.
- Absence of any condition hampering compliance with the study protocol and follow-up schedule.
- Adequate organ function as defined by specific hematological, renal, and hepatic lab values.
You will not qualify if you...
- Clinically significant active cardiovascular disease such as recent stroke, myocardial infarction, unstable angina, heart failure, or serious arrhythmia.
- Current use of immunosuppressive medication except for inhaled, topical steroids, local injections, low-dose systemic corticosteroids, or premedication steroids.
- Known severe hypersensitivity to the investigational product or related components.
- Other severe acute or chronic medical conditions or lab abnormalities that increase risk or interfere with study participation or results interpretation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks (4 cycles of 3 weeks each)
Participants receive prophylactic Mesalamine four times a day in combination with standard immunotherapy treatment with Nivolumab and Ipilimumab.
Weekly visits for up to 12 weeks
Duration - Up to 24 weeks post treatment
Participants are monitored for immune-related adverse events and treatment-related diarrhea after treatment ends.
Visits at 12, 18, and 24 weeks post treatment
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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