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Background

Nasopharyngeal cancer (NPC) is common in Southeast Asia and Southern China. It is infiltrated by T-regulatory cells and shows high expression of PD-L1. However, monotherapy PD-1/PD-L1 activity is limited and not superior to salvage combination chemotherapy. We hypothesized that CTLA-4 blockade would suppress T-regulatory function and complement PD-1 blockade. We update the efficacy and safety from the first phase II study of this combination in NPC.

Methods

A single arm phase II of a Simon 2-stage design was used, with preplanned expansion for safety and efficacy. Pts were treated with Nivolumab 3 mg/kg q2 weeks, and Ipilimumab 1 mg/kg q6 weeks. Eligible pts had R/M NPC, measurable plasma EBV DNA, no more than 1 prior line of chemotherapy, ECOG 0-1, and adequate organ function. All pts who met the eligibility criteria and received at least one dose of the combination drugs …