Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Laryngeal Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Cisplatin

Participants will receive 3 cycles of oral solution of Xevinapant (Debio 1143) at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of Xevinapant (Debio 1143) at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Xevinapant (Debio 1143)

Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week.

IMRT

Participants will receive 3 cycles of oral solution of placebo matched to Xevinapant (Debio 1143) once daily from Day 1 to 14 per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of placebo matched to Xevinapant (Debio 1143) from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Placebo

US Medical Information

Communication Center

James Bonner

Robert Haddad

Ammar W Sukari

Rafi Kabarriti

Zujun Li

Sara A Medek

Robert Ferris

Richard O Neal

Diego Lucas Kaen

Jorge Emilio Salinas

Alejandro Sola

Ruben D Kowalyszyn

Martin Burian

Richard F Greil

Tatiana Dragan

Jean Pascal Machiels

Marika Rasschaert

Willem Lybaert

Carlos E Baston Silva

Fabrício Augusto Martinelli de Oliveira

Fabricio Pontes Grando

Iane F Pinto Figueiredo Lima

Fabio André Franke

Rivadavio Antunes Menacho de Oliveira

Silvio C Sales

Alan Arrieira Azambuja

Sergio Jobim de Azevedo

Katsuki Arima Tiscoski

Pedro Rafael Martins De Marchi

Jamille G Dutra

Daniel O Brito

Claudia Vaz de Melo Sette

Lucas Vieira dos Santos

Milena Perez Mak

Denis Soulieres

Yan Sun

Yajun Zhang

Xin Jiang

Yaqian Han

Liangfang Shen

Mei Feng

Lei Liu

Yue Xie

Shaojun Lin

Shaoxiong Wu

Xiaonan Sun

Xianzhong Chen

Jin Gao

Man Hu

Jingao Li

Jing Yan

Song Qu

Chaosu Hu

Pin Dong

Caigang Liu

Peiguo Wang

Kunyu Yang

Hongbing Ma

Buhai Wang

Hui Wu

Bohuslav Melichar

Katerina Lickova

Petra Holeckova

Aurore Goineau

Amaury Daste

Ulrike Schick

Juliette Thariat

Noemie Vulquin

Matthieu Bosset

Yoann Pointreau

Xavier Liem

Christian Sire

Ariane Lapierre

Sebastien Salas

Pierre Boisselier

Alexis Lenglet

Esma Saada-Bouzid

Valentin Calugaru

Florence Huguet

Camille Evrard

Sebastien Thureau

Francois Georges Riet

Frederic Rolland

Christian Borel

Xavier Tchiknavorian

Anouchka Modesto

Sophie Chapet

Yungan Tao

Tamta Makharadze

Eter Natelauri

Amiran Matitashvili

Miranda Gogishvili

Tamar Melkadze

Davit Giorgadze

Maike de Wit

Christine Langer

Rami El Shafie

Medical Responsible

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

* Radiotherapy
* Cisplatin
* Xevinapant (Debio 1143)

Monotherapy period (Cycles 4-6):

• Xevinapant (Debio 1143)

Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

* Radiotherapy
* Cisplatin
* Matched placebo

Monotherapy period (Cycles 4-6):

• Matched placebo

Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.

Cisplatin administered as an IV infusion every 3 weeks (Q3W).

70 Gy given in 35 fractions over 7 weeks.

Intensity Modulation Radiation Therapy (IMRT)

Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

The primary objective of the study is 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).

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)

A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

EFS is the time from the date of randomization to the date of first record of disease progression or death.

OS is the time from randomization to death due to any cause.

PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)

ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).

CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).

Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.

Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)

Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H\&N35)

GORTEC (Head and Neck Oncology and Radiotherapy Group)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)	NCT05386550	Head and Neck C...	Xevinapant (Deb... IMRT Placebo	18 Years -	EMD Serono
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)	NCT05386550	Head and Neck C...	Xevinapant (Deb... IMRT Placebo	18 Years -	EMD Serono
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)	NCT04459715	Squamous Cell C...	Xevinapant (Deb... Cisplatin Intensity Modul... Placebo	18 Years -	EMD Serono

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