Grant: Project Grant

Melanoma is the most dangerous form of skin cancer. Previously, patients with melanoma that could not be cured with surgery only survived 6-9 months. Since 2010, new medicines that activate the immune system to target cancer cells, called immune checkpoint inhibitors (ICIs), have greatly improved survival. The combination of two ICIs (ipilimumab and nivolumab) is now a standard treatment for advanced melanoma. However, 30% of patients treated with this combination of ICIs will develop severe side effects, the most common being inflammation in the gastrointestinal (GI) tract (called colitis) that leads to diarrhea, abdominal pain, and bowel bleeding. Currently, no treatments have been shown to prevent ICI-related diarrhea/colitis. VERIFY is a Canadian trial that will test if a treatment called vedolizumab can prevent ICI-related diarrhea/colitis. Vedolizumab is already approved for patients with a similar disease called inflammatory bowel disease (IBD). Vedolizumab blocks inflammation cells from getting to the GI tract and has been shown to be very safe. In VERIFY, patients with melanoma starting ipilimumab and nivolumab will be randomly prescribed additional treatment with either vedolizumab or placebo (a "dummy" treatment without any real medical effects). We will then measure how many patients develop ICI-related diarrhea/colitis over the next 6 months to see if vedolizumab prevents patients from developing this complication. Before embarking on the full VERIFY trial, we propose conducting a smaller preliminary pilot study in 5 hospitals to ensure that there are enough patients who would participate, that the trial procedures are acceptable to patients and doctors, and that the participating sites can successfully follow the treatment schedule. This study is important because it represents a potentially better way to care for patients with advanced skin cancer and reduce their risk of developing a serious complication from their cancer treatment.