A phase II trial evaluating treatment intensification with Ezabenlimab in patients with PD-L1–expressing, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) with minimal residual disease (MRD) as detected by circulating tumor DNA (ctDNA) after curative-intent chemoradiation

Condition studied

Locally advanced head and neck squamous cell carcinoma (LA-HNSCC)

Investigational medicinal product(s)

Eligibility

Primary endpoint

EFS rate at 2-years in MRD-positive patients (interventional cohort) where EFS rate is defined as the proportion of patients who have not experienced any EFS event at 2 years after MRD assessment (i.e., after CRT).

Endpoint detail

Frequency and severity of TEAEs, irAEs, IRRs, serious AEs (SAE) TEAE/SAEs leading to dose delays, withdrawal or death. Clinically significant changes in laboratory, vital signs, and safety assessment parameters., Change from baseline in QoL as assessed by the EORTC QLQ-C30 and QLQ-HN43. Participant-reported frequency and severity of symptomatic toxicity based on PRO-CTCAE and FACT-GP5 and frequency distribution of PGIS/PGIC over time., Correlation of post-CRT ctDNA-based MRD status, ctDNA longitudinal changes (such as molecular response) with clinical activity and response. Change of ctDNA status (approx. every 3 months)., OS defined as the time from post-CRT MRD assessment to death from any cause., EFS is defined as the time from post-CRT MRD assessment to disease progression, recurrence, or death from any cause, whichever comes first