Discontinuation of the double-blind, placebo-controlled randomized, phase III GORTEC 2022-01 trial of radiotherapy-cetuximab and xevinapant in patients with locally advanced squamous cell carcinoma of the head and neck, unfit for cisplatin.

Pointreau, Y; Larnaudie, A; Sun, X S; Rolland, F; Boisselier, P; Tao, Y; Hugo, C; Bourhis, J · Radiother Oncol · 2026

rct · Level II

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Abstract

XXL was a placebo-controlled phase 3 evaluating cetuximab-radiotherapy and xevinapant (IAP inhibitor) in locally advanced squamous cell carcinoma of the head and neck, ineligible for cisplatin (Unfit). Following the unfavorable outcomes of Trilynx [1], XXL the trial was prematurely discontinued after the enrollment of 19 patients and subsequently unblinded; the safety analysis then revealed an increase in treatment-related deaths with xevinapant.