JADE: phase 3 study of sequential dostarlimab post chemoradiotherapy in patients with locally advanced unresected HNSCC.

[INTRODUCTION] 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.

[METHODS] 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.

[CLINICAL TRIAL REGISTRATION] www.clinicaltrials.gov identifier is NCT06256588.