Phase 2 Study of Nivolumab Combined with Gemcitabine, Cisplatin, and Radiation Therapy in Children, Adolescents, and Young Adults with Newly Diagnosed Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are investigating the effects of combining nivolumab, an immunotherapy drug, with chemotherapy drugs gemcitabine and cisplatin before radiation therapy in children, adolescents, and young adults newly diagnosed with nasopharyngeal carcinoma NPC. This phase II trial aims to evaluate both the safety and effectiveness of this combination treatment, focusing on immune-related side effects and cancer control outcomes. The study also explores whether reducing radiation doses can lessen side effects for pediatric patients. Participants receive induction therapy with nivolumab intravenously on day 1, gemcitabine intravenously on days 1 and 8, and cisplatin intravenously on day 1 of each 21-day cycle, repeated for 3 cycles if tolerated. This is followed by consolidation therapy with nivolumab and cisplatin intravenously on day 1 of 3 cycles every 21 days, alongside concurrent radiation therapy with adjusted doses based on response. Finally, maintenance therapy consists of nivolumab given intravenously every 28 days for 6 cycles as long as no disease progression or unacceptable toxicity occurs. Throughout the study, participants undergo various assessments including echocardiography or MUGA scans, MRI, FDG PET, CT scans, chest X-rays, and dental X-rays. Optional tissue biopsies and blood and stool sample collections are also performed. Follow-up visits occur every 3 months for one year, then every 6 months up to two years, and annually up to five years after treatment ends. Researchers measure immune-related adverse events, event-free survival, response rates, relapse incidence, quality of life, swallowing function, and long-term toxicity.

A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)