Phase III clinical trial - VADS

TrilynX (Debio 1143-SCCHN-301)
VADS
Ouvert depuis le: 12.03.2021
Site: Paris
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Adulte
A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in;combination with platinum-based chemotherapy and standard fractionation intensitymodulated;radiotherapy in patients with locally advanced squamous cell carcinoma of;the head and neck, suitable for definitive chemoradiotherapy (TrilynX).
Description de l'essai

This is a prospective, randomized, double-blind, placebo-controlled, multicenter, 2-arm, parallel-group Phase 3;study comparing the efficacy and safety of Debio 1143 versus matched placebo, when administered in combination;with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy (IMRT) in;previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN),;suitable for definitive chemoradiotherapy (CRT) (stage III, IVA, IVB; hypopharynx, larynx and/or human;papillomavirus [HPV]-negative oropharyngeal cancer [OPC]).