LIM-2023-NIVO-IPI-NPC

NCT03097939 📎

Regimen

Experimental
Nivolumab 3 mg/kg IV q2w + ipilimumab 1 mg/kg IV every 6 weeks until progression or unacceptable toxicity
Control
none

Population

Recurrent or metastatic EBV-positive NPC who failed prior platinum-based chemotherapy; enrolled at Singapore center (NCCS); unselected for PD-L1 or TMB

Key finding

The dual PD-1/CTLA-4 blockade strategy (nivolumab + ipilimumab) produced a 38% BOR in platinum-pretreated EBV-positive RM NPC — numerically higher than nivolumab monotherapy (NCI-9742: 20.5%) or pembrolizumab (KEYNOTE-028: 25.9%), though the trial did not meet its pre-planned BOR threshold. No correlation was found with PD-L1 or TMB; low baseline EBV DNA (<7800 IU/ml) trended to better outcomes. Deep immunophenotyping identified CTLA-4/PD-1 co-expressing CD8 subpopulations as potential predictive biomarkers.

Source: PMID 37188668

Timeline