JADE：局所進行未切除HNSCC患者における化学放射線療法後のドスタルリマブ逐次投与に関する第III相試験

Head and neck squamous cell carcinoma (HNSCC) accounts for approximately 5% of cancer cases worldwide, with more than half of patients presenting with locally advanced (LA) disease. Treatment of LA HNSCC is multimodal and may include concomitant cisplatin-based chemoradiotherapy (CRT) or surgery; however, recurrence rates are high, and there is an unmet need for new treatments. Immune checkpoint inhibitors that target programmed death receptor-1 (PD-1) are standard of care for recurrent/metastatic HNSCC, but outcomes for anti-PD-1 and anti-PD-(ligand [L])1 therapies with CRT in LA HNSCC have been variable. Dostarlimab, an anti-PD-1 therapy approved in advanced endometrial cancer and mismatch repair-deficient solid tumors is being investigated across other tumor types, including HNSCC. JADE is a global, multicenter, double-blind, placebo-controlled, randomized phase 3 study evaluating the efficacy and safety of dostarlimab as post-cisplatin-based CRT sequential therapy in patients with LA unresected PD-L1-expressing HNSCC. JADE seeks to overcome the limitations of previous studies by incorporating both PD-L1 selection and solely sequential administration of dostarlimab soon after CRT.

The primary endpoint is event-free survival, with overall survival as a key secondary endpoint; safety and tolerability, pharmacokinetics, immunogenicity, biomarkers, and patient-reported outcomes will also be assessed.

www.clinicaltrials.gov identifier is NCT06256588.