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

Conditions

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

Brief summary

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).

Detailed description

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

Related papers

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Interventions

DRUGEzabenlimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed