Ipilimumab is a drug approved for the treatment of melanoma skin cancers in adults. It has been evaluated in children with cancer, but its use in children and adolescents is considered investigational. The purpose of this study is to evaluate the safety and effectiveness of ipilimumab in children and adolescents (ages 12 to less than 17) with inoperable stage III or stage IV melanoma. Participants will receive a dose that is higher than the FDA-approved dose, but has been shown in prior studies to be safe in children with cancer.
Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy cancer cells.