Preventing Immune-Related Colitis with Oral Mesalamine in Adults Receiving Ipilimumab and Nivolumab for Advanced Melanoma

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.

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