Paco De Arcos

Researchers are investigating new treatments for children with different types of advanced, relapsed, or refractory melanoma, solid tumors, and lymphomas that cannot be cured by surgery or have not responded well to previous therapies. This study focuses on evaluating pembrolizumab, an immunotherapy drug that helps the immune system fight cancer. The study is a Phase I/II trial that includes children from 6 months to under 18 years old, but some enrollment groups have closed based on recent amendments. Participants will receive pembrolizumab through an intravenous infusion. The study includes multiple groups based on cancer type, including melanoma, classical Hodgkin lymphoma, and solid tumors with specific genetic markers. The treatment aims to assess different doses of pembrolizumab to see if it can shrink or eliminate tumors. Enrollment for some groups, such as children under 12 with melanoma and certain tumor types, has been closed as the trial progresses. During the study, participants will be evaluated for tumor response using established criteria and monitored for side effects and toxicities for up to two years. Researchers will collect tissue samples and conduct regular assessments including scans, laboratory tests, and physical exams. The study tracks safety, treatment discontinuations due to adverse events, and overall response rates to understand the drug’s effects in these pediatric cancers.