The JADE trial

Despite multimodal treatment, half of the patients with locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN) will suffer a disease recurrence. To mitigate this risk of recurrence, several studies are exploring the potential of giving immunotherapy after chemoradiotherapy (CRT) in this setting. Unfortunately, both KEYNOTE-412 and IMvoke010 failed to show an improved outcome with anti–PD-(L)1 therapy administered concurrently and sequentially to CRT in an all-comer LA-SCCHN population. Interestingly, however, a post hoc analysis of KEYNOTE-412 did indicate a numerically better outcome in patients with a high PD-L1 expression.

JADE is a randomised, double-blind, placebo-controlled phase III study enrolling adult patients with a newly diagnosed, unresected LA-HNSCC who completed concurrent CRT with curative intent. In contrast to previous trials, patients need to have a PD-L1 CPS score of ≥1 to be eligible for the study. Following CRT, patients in the study will be randomised (1:1) to receive dostarlimab or placebo. The primary endpoint is event-free survival (EFS) with overall survival, EFS per investigator assessment, safety, tolerability, pharmacokinetics, and the development of anti-drug antibodies as secondary study objectives.

The JADE study is actively recruiting patients in 21 countries, including Belgium and has an estimated primary completion date of 2028.