Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design
Jean Bourhis, Barbara Burtness, Lisa F Licitra, Christopher Nutting, Jonathan D Schoenfeld, Mokhtar Omar, Florilene Bouisset, Heidi Nauwelaerts, Yulia Urfer, Claudio Zanna, Ezra Ew Cohen, Jean Bourhis, Barbara Burtness, Lisa F Licitra, Christopher Nutting, Jonathan D Schoenfeld, Mokhtar Omar, Florilene Bouisset, Heidi Nauwelaerts, Yulia Urfer, Claudio Zanna, Ezra Ew Cohen
Abstract
Xevinapant is a first-in-class antagonist of inhibitor of apoptosis proteins, which enhances cancer cell sensitivity to chemotherapy and radiotherapy. In a phase II randomized study in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), xevinapant plus standard-of-care cisplatin-based chemoradiotherapy (CRT) showed superior efficacy versus placebo plus CRT. Here, we describe the design of TrilynX (NCT04459715), a randomized, double-blind, phase III study. In total, 700 patients with unresected LA SCCHN will be randomized 1:1 to receive xevinapant or placebo plus standard-of-care CRT followed by xevinapant monotherapy or placebo. The primary end point is event-free survival by blinded independent review committee. Secondary end points include progression-free survival, locoregional control, overall survival and safety.
Keywords: chemoradiotherapy; hypopharynx; inhibitor of apoptosis proteins; larynx; locally advanced squamous cell carcinoma of the head and neck; oropharynx; xevinapant.
Source: PubMed