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

Summary

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

Timeline

Start

2020-08-07

Primary completion

2024-09-18

Completion

2024-09-18

Outcome

Missed primary endpoint

Stopped: “Study has crossed the pre-defined futility boundary at the Interim Analysis.”

paper with xevinapant and 33.1 months (21.0 to not estimable) with placebo (hazard ratio [HR], 1.33 [95% CI, 1.05 to 1.67]; P = .9919). PMID 40902136 ↗

paper Xevinapant plus CRT did not improve EFS (EFS was shorter with xevinapant v placebo) PMID 40902136 ↗

Publications

• Bourhis J, Licitra LF, Burtness B, Psyrri A, Haddad R, Harrington K, Cohen EEW, Tao Y, Tiscoski KA, Matitashvili A, Tahara M, Sukari A, Rutkowski T, Salas S, Nauwelaerts H, Scheerlinck R, Ha NT, Schroeder A, Rodriguez-Gutierrez A, Schoenfeld JD. Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study. J Clin Oncol. 2025 Oct 10;43(29):3209-3220. doi: 10.1200/JCO-25-00272. Epub 2025 Sep 3.
• Bourhis J, Burtness B, Licitra LF, Nutting C, Schoenfeld JD, Omar M, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen EE. Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design. Future Oncol. 2022 May;18(14):1669-1678. doi: 10.2217/fon-2021-1634. Epub 2022 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Xevinapant	Small molecule	200 mg	Oral
Background	Cisplatin	Other / unclassified	100 mg/m2	Intravenous

Indications