Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design

Robert L Ferris; Hisham Mehanna; Jonathan D Schoenfeld; Makoto Tahara; Sue S Yom; Robert Haddad; André König; Pauline Witzler; Marcis Bajars; Christophe Le Tourneau

doi:10.2217/fon-2023-0774

Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design

Robert L Ferris, Hisham Mehanna, Jonathan D Schoenfeld, Makoto Tahara, Sue S Yom, Robert Haddad, André König, Pauline Witzler, Marcis Bajars, Christophe Le Tourneau^*

^*Corresponding author for this work

Vice-Chancellor's Office

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Abstract

There is a significant unmet need and lack of treatment options for patients with resected, high-risk, cisplatin-ineligible locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Xevinapant, a first-in-class, potent, oral, small-molecule IAP inhibitor, is thought to restore cancer cell sensitivity to chemotherapy and radiotherapy in clinical and preclinical studies. We describe the design of XRay Vision (NCT05386550), an international, randomized, double-blind, phase III study. Approximately 700 patients with resected, high-risk, cisplatin-ineligible LA SCCHN will be randomized 1:1 to receive 6 cycles of xevinapant or placebo, in combination with radiotherapy for the first 3 cycles. The primary end point is disease-free survival, and secondary end points include overall survival, health-related quality of life, and safety.

Original language	English
Journal	Future Oncology
Early online date	10 Jan 2024
DOIs	https://doi.org/10.2217/fon-2023-0774
Publication status	E-pub ahead of print - 10 Jan 2024

Bibliographical note

Financial disclosure:
The study is sponsored by Merck (CrossRef Funder ID: 10.13039/100009945). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Keywords

hypopharynx
inhibitor of apoptosis protein
larynx
locally advanced squamous cell carcinoma of the head and neck
oral cavity
oropharynx
phase III
radiotherapy
resected
xevinapant

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.2217/fon-2023-0774Licence: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)

FerrisR2023XevinapantFinal published version, 1.61 MBLicence: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)

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title = "Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design",

abstract = "There is a significant unmet need and lack of treatment options for patients with resected, high-risk, cisplatin-ineligible locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Xevinapant, a first-in-class, potent, oral, small-molecule IAP inhibitor, is thought to restore cancer cell sensitivity to chemotherapy and radiotherapy in clinical and preclinical studies. We describe the design of XRay Vision (NCT05386550), an international, randomized, double-blind, phase III study. Approximately 700 patients with resected, high-risk, cisplatin-ineligible LA SCCHN will be randomized 1:1 to receive 6 cycles of xevinapant or placebo, in combination with radiotherapy for the first 3 cycles. The primary end point is disease-free survival, and secondary end points include overall survival, health-related quality of life, and safety.",

keywords = "hypopharynx, inhibitor of apoptosis protein, larynx, locally advanced squamous cell carcinoma of the head and neck, oral cavity, oropharynx, phase III, radiotherapy, resected, xevinapant",

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note = "Financial disclosure: The study is sponsored by Merck (CrossRef Funder ID: 10.13039/100009945). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.",

year = "2024",

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doi = "10.2217/fon-2023-0774",

language = "English",

journal = "Future Oncology",

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TY - JOUR

T1 - Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN

T2 - the phase III XRay Vision study design

AU - Ferris, Robert L

AU - Mehanna, Hisham

AU - Schoenfeld, Jonathan D

AU - Tahara, Makoto

AU - Yom, Sue S

AU - Haddad, Robert

AU - König, André

AU - Witzler, Pauline

AU - Bajars, Marcis

AU - Tourneau, Christophe Le

N1 - Financial disclosure: The study is sponsored by Merck (CrossRef Funder ID: 10.13039/100009945). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

PY - 2024/1/10

Y1 - 2024/1/10

N2 - There is a significant unmet need and lack of treatment options for patients with resected, high-risk, cisplatin-ineligible locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Xevinapant, a first-in-class, potent, oral, small-molecule IAP inhibitor, is thought to restore cancer cell sensitivity to chemotherapy and radiotherapy in clinical and preclinical studies. We describe the design of XRay Vision (NCT05386550), an international, randomized, double-blind, phase III study. Approximately 700 patients with resected, high-risk, cisplatin-ineligible LA SCCHN will be randomized 1:1 to receive 6 cycles of xevinapant or placebo, in combination with radiotherapy for the first 3 cycles. The primary end point is disease-free survival, and secondary end points include overall survival, health-related quality of life, and safety.

AB - There is a significant unmet need and lack of treatment options for patients with resected, high-risk, cisplatin-ineligible locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Xevinapant, a first-in-class, potent, oral, small-molecule IAP inhibitor, is thought to restore cancer cell sensitivity to chemotherapy and radiotherapy in clinical and preclinical studies. We describe the design of XRay Vision (NCT05386550), an international, randomized, double-blind, phase III study. Approximately 700 patients with resected, high-risk, cisplatin-ineligible LA SCCHN will be randomized 1:1 to receive 6 cycles of xevinapant or placebo, in combination with radiotherapy for the first 3 cycles. The primary end point is disease-free survival, and secondary end points include overall survival, health-related quality of life, and safety.

KW - hypopharynx

KW - inhibitor of apoptosis protein

KW - larynx

KW - locally advanced squamous cell carcinoma of the head and neck

KW - oral cavity

KW - oropharynx

KW - phase III

KW - radiotherapy

KW - resected

KW - xevinapant

U2 - 10.2217/fon-2023-0774

DO - 10.2217/fon-2023-0774

M3 - Review article

C2 - 38197296

SN - 1479-6694

JO - Future Oncology

JF - Future Oncology

ER -

Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design

Abstract

Bibliographical note

Keywords

UN SDGs

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