ARAR2221 A Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)
Objective
Primary Aim: To evaluate safety of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC) by determining the rate of CTCAE Grade 3 or higher immune related adverse events (irAEs).
Secondary Aims: To estimate the 2-year event-free survival (EFS) of children, adolescents and young adults with NPC who are treated with Induction Chemoimmunotherapy (CIT), followed by Consolidation Chemoradioimmunotherapy (CRIT, cisplatin, nivolumab and response-adjusted, dose de-escalated radiation therapy), and nivolumab maintenance therapy. To evaluate the objective response rate (ORR) including complete responders and partial responders (CR + PR) of neoadjuvant CIT. To evaluate feasibility of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC). To evaluate the cumulative incidence of local and distant relapse.
