A Study of Debio 1143 (Xevinapant) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiation Therapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy

Titre officiel

A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Sommaire:

The primary objective of the study is to demonstrate superior efficacy of Debio 1143 vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Description de l'essai

Primary Outcome:

• Event-Free Survival (EFS)

• Progression-Free Survival (PFS)
• Overall survival (OS)
• Locoregional Control (LRC)
• Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure
• Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
• Changes from Baseline in Swallowing and Pain Symptoms

Voir cet essai sur ClinicalTrials.gov