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.

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Title: 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.
Authors: Pointreau, Y.1 (AUTHOR) y.pointreau@ilcgroupe.fr, Larnaudie, A.2 (AUTHOR), Sun, X.S.3 (AUTHOR), Rolland, F.4 (AUTHOR), Boisselier, P.5 (AUTHOR), Tao, Y.6 (AUTHOR), Hugo, C.7 (AUTHOR), Bourhis, J.8 (AUTHOR)
Source: Radiotherapy & Oncology. Jun2026, Vol. 219, pN.PAG-N.PAG. 1p.
Subjects: Cetuximab, Head & neck cancer, Squamous cell carcinoma, Radiotherapy, Cisplatin, Apoptosis inhibition, Clinical trials, Adverse health care events
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. [ABSTRACT FROM AUTHOR]
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Database: Engineering Source
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