A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high risk for relapse and are ineligible for high-dose cisplatin

Objective:

Primary Objective:

• To demonstrate improvement in Disease-Free Survival (DFS) with xevinapant compared to placebo when added to RT irrespective of subsequent anticancer therapy

Secondary Objectives:

• To demonstrate improvement in OS with xevinapant compared to placebo when added to RT followed by subsequent anticancer therapy.
• To evaluate time to subsequent cancer treatments in participants treated with xevinapant compared to placebo when added to RT.
• To evaluate the safety and tolerability of xevinapant compared to placebo when added to RT.
• To evaluate xevinapant compared to placebo when added to RT followed by xevinapant onotherapy in terms of patient-reported head and neck pain, swallowing, and speech as measured by the EORTC H&N35 sub scales, patient-reported fatigue, physical function, and global health status as measured by the EORTC QLQ C-30 sub scales and EQ5D-5L VAS.