This study was designed to compare the efficacy and safety of tislelizumab (BGB-A317) combined with gemcitabine plus cisplatin versus placebo combined with gemcitabine plus cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal cancer.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Previously untreated recurrent/metastatic NPC |
Tislelizumab + Gemcitabine + Cisplatin |
Placebo + Gemcitabine + Cisplatin |
Primary Endpoint: PFS by IRC Key Secondary Endpoints: OS, ORR, DoR, INV-assessed PFS and PFS2, safety Exploratory: Biomarker analysis |