Study Comparing RT With Cetuximab + Xevinapant to RT With Cetuximab-placebo in Patients With Head and Neck Cancer
Status:
Recruiting
Trial end date:
2030-09-01
Target enrollment:
Participant gender:
Summary
Xevinapant is an antagonist of inhibitor of apoptosis proteins (IAPs) that has been shown
both chemo-, radiosensitizing, and immunomodulatory activities in nonclinical in vitro and in
vivo squamous cell carcinoma of the head and neck (SCCHN) models. In previously untreated
patients with non-resected locally advanced SCCHN, the addition of xevinapant recently showed
a significant improvement of progression-free survival (PFS), overall survival (OS) and
loco-regional control at 3 years after completing treatment. Thus, the purpose of this Phase
III study is to demonstrate the superior efficacy to the xevinapant when it is administered
in combination with radiotherapy (RT)+cetuximab compared to radiotherapy+cetuximab (SoC) +
placebo in previously untreated participants with LA-SCCHN, ineligible for high-dose
cisplatin defined as ≥ 200 mg/m² (projective total cumulative dose) throughout the course of
the radiotherapy.