AzTrials
AzTrials

Head and Neck CancerPhase 3NCT05386550

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

A Phase 3 study testing Xevinapant and IMRT in people with Head and Neck Cancer, run by EMD Serono Research & Development Institute, Inc. at 206 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Xevinapant and IMRT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
206 sitesin 26 countries
Study dates
6 Oct 2022to 27 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 and able to tolerate standard of care IMRT treatment according to Investigator assessment
  • Participants with histologically confirmed squamous cell carcinoma with one of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx. Participants have received surgery with curative intent on these sites in the past 4 to 10 weeks before start of treatment (Cycle 1 Day 1)
  • Oropharynx (OPC) participants must have known human papillomavirus (HPV) status as determined by p16 expression using immunohistochemistry (ICH)
  • Participants with no residual disease by computed tomography (CT) or magnetic resonance imaging (MRI) and have a high risk of relapse with 1 or 2 of the following criteria, confirmed by local histopathology: • nodal extra-capsular extension (ECE) and positive resection margins (R1 or close margin less than or equal to (<=) 1 millimeter (mm)
  • Are unfit to receive high-dose cisplatin by meeting one or more of the following criteria: estimated glomerular filtration rate (eGFR) < 60 milliliter per minute per 1.73 meter square (mL/min /1.73 m^2); History of hearing impairment, defined as Grade >= 2 audiometric hearing loss or tinnitus Grade >= 2. An audiogram is not required if one of the other criteria meets unfitness to receive high-dose cisplatin; Peripheral neuropathy > = Grade 2 and if >= 70 years, unfit according to G8 questionnaire (Score <= 14) or ineligible for cisplatin treatment due to age limit according to national guidelines
  • Participants with adequate renal, hematologic and hepatic function as defined in the protocol
  • Other protocol-defined inclusion criteria could apply

Who cannot join

  • Any condition, including any uncontrolled disease state other than SCCHN that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
  • Participants with incomplete surgery
  • Participants with recurrent or metastatic disease
  • Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity, salivary, thyroid or parathyroid gland, skin or unknown primary site
  • Prior definitive, neoadjuvant, concurrent or adjuvant (C)RT to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents
  • Participation in any interventional clinical study within 28 days prior to screening or during participation in this study
Show all 9Show fewer
  • Known contraindication to undergoing positron emission tomography with 18F-FDG-PET-CT scans, or both contrast-enhanced MRI and contrast-enhanced CT scans
  • Known allergy to Xevinapant (Debio 1143) or any excipient known to be present in Xevinapant (Debio 1143) or in the placebo formulation
  • Other protocol-defined exclusion criteria could apply

Trial locations and contacts

206 sites in 26 countries.

206 sites in 26 countries

China25 sites

  • Beijing Cancer Hospital

    Beijing

  • Hospital of Bengbu Medical College

    Bengbu

  • The First Hospital of Jilin University

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Xiangya Hospital, Central South University

    Changsha

  • Sichuan Cancer Hospital

    Chengdu

  • West China Hospital, Sichuan University

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing

  • Fujian Cancer Hospital

    Fuzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Sir Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Anhui Provincial Cancer Hospital

    Hefei

  • Shandong Cancer Hospital

    Jinan

  • Jiangxi Cancer Hospital

    Nanchang

  • Nanjing Drum Tower Hospital

    Nanjing

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Shanghai General Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

    Wuhan

  • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)

    Xi'an

  • Northern Jiangsu People's Hospital

    Yangzhou

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

France25 sites

  • ICO - Site Paul Papin - service d'oncologie medicale

    Angers

  • CHU Bordeaux - Service d'Oncologie Médicale

    Bordeaux

  • CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale

    Brest

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen

  • Centre Georges François Leclerc - Oncologie Médicale

    Dijon

  • Hopital Prive Drome Ardeche - Service D Oncologie

    Guilherand-Granges

  • Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale

    Le Mans

  • Centre Oscar Lambret - service de cancerologie gynecologique

    Lille

  • Centre Hospitalier de Bretagne Sud

    Lorient

  • Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale

    Lyon

  • Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs

    Marseille

  • Institut Régional du Cancer de Montpellier - Service de Professeur Senesse

    Montpellier

  • Centre Azureen Cancerologie - Service De Radiotherapie

    Mougins

  • Centre Antoine Lacassagne - Service d'Hématologie Oncologie

    Nice

  • Hopital Tenon - service radiologie et imagerie medicale

    Paris

  • Institut Curie - site de Paris - Service d'Oncologie Médicale

    Paris

  • CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

    Poitiers

  • Centre Henri Becquerel - Service de radiothérapie

    Rouen

  • Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie

    Saint-Grégoire

  • ICO - Site René Gauducheau - Service d'Oncologie medicale

    Saint-Herblain

  • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

    Strasbourg

  • CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie

    Toulon

  • Institut Claudius Regaud - service de Radiothérapie

    Toulouse

  • CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale

    Tours

  • Institut Gustave Roussy - Oncologie Médicale

    Villejuif

Other trials in France

Japan20 sites

  • Hyogo Cancer Center - Dept of Head and Neck Surgery

    Akashi-shi

  • National Cancer Center Hospital - Dept of Gastroenterology

    Chūōku

  • NHO Kyushu Cancer Center - Dept of Head and Neck Surgery

    Fukuoka

  • Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery

    Hidaka-shi

  • Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery

    Hiroshima

  • National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology

    Kashiwa-shi

  • Kagawa University Hospital - Dept of Oncology

    Kita-gun

  • Saitama Cancer Center - Dept of Head and Neck Surgery

    Kitaadachi-gun

  • Kobe University Hospital - Dept of Oncology/Hematology

    Kobe

  • Cancer Institute Hospital of JFCR - Dept of Medical Oncology

    Kōtoku

  • NHO Shikoku Cancer Center - Dept of Head and Neck Surgery

    Matsuyama

  • Aichi Cancer Center Hospital - Dept of Head and Neck Surgery

    Nagoya

  • Nagoya University Hospital - Dept of Otorhinolaryngology

    Nagoya

  • Okayama University Hospital - Dept of Otorhinolaryngology

    Okayama

  • Osaka International Cancer Institute - Dept of Head and Neck Surgery

    Osaka

  • Kindai University Hospital - Dept of Oncology

    Osakasayama-shi

  • Hokkaido University Hospital - Dept of Otorhinolaryngology

    Sapporo

  • NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery

    Sapporo

  • Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery

    Sendai

  • Yokohama City University Hospital - Dept of Otorhinolaryngology

    Yokohama

Other trials in Japan

Brazil16 sites

  • Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor

    Barretos

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba

  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica

    Florianópolis

  • CRIO - Centro Regional Integrado de Oncologia

    Fortaleza

  • Oncosite - Centro de Pesquisa Clinica e Oncologia

    Ijuí

  • Instituto de Cancer de Londrina

    Londrina

  • Liga Norte-Rio-Grandense Contra o Câncer

    Natal

  • HGB - Hospital Giovanni Battista - Mãe de Deus Center

    Porto Alegre

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre

  • Grupo Oncoclínicas

    Rio de Janeiro

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro

  • Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia

    Salvador

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

    Santo André

  • BP A Beneficencia Portuguesa da Sao Paulo

    São Paulo

  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

    São Paulo

Other trials in Brazil

Italy15 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica

    Brescia

  • Ospedale Oncologico Armando Businco - Divisione di Oncologia Medica II

    Cagliari

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia

    Candiolo

  • Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica

    Florence

  • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare

    Meldola

  • Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo

    Milan

  • IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

    Milan

  • Ospedale San Raffaele - U.O. di Oncologia Medica

    Milan

  • A.O.U. Policlinico di Modena - U.O. Oncologia

    Modena

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia

    Naples

  • Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A

    Naples

  • IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

    Padova

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B

    Roma

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1

    Roma

  • Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

    Rozzano

Other trials in Italy

Spain14 sites

  • Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera

    A Coruña

  • Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia

    A Coruña

  • Hospital Clinic de Barcelona - Medical Oncology

    Barcelona

  • Hospital del Mar - Servicio de Oncologia

    Barcelona

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica

    Barcelona

  • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

    Barcelona

  • Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia

    Las Palmas de Gran Canaria

  • Hospital Universitario Lucus Augusti - Oncology

    Lugo

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz - Oncology

    Madrid

  • Hospital Universitario La Paz - Oncology Department

    Madrid

  • Hospital Regional Universitario de Malaga - Oncology Dept

    Málaga

  • Hospital Universitario Virgen del Rocio - Oncology Service

    Seville

Other trials in Spain

United States10 sites

  • UC Health

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham - Dept of Radiation Oncology

    Birmingham, Alabama, 35249

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45219

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Prisma Health Cancer Institute, ITOR, CRU

    Greenville, South Carolina, 29605

  • Perlmutter Cancer Center at NYU Langone Hospital ae Long Island

    New York, New York, 10016

  • University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology

    Pittsburgh, Pennsylvania, 15219

  • Montefiore Medical Center Radiology

    The Bronx, New York, 10461

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

Other trials in United States

Taiwan9 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Chi Mei Hospital, Liouying

    Tainan

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan

Other trials in Taiwan

United Kingdom8 sites

  • St James's University Hospital - Dept of Oncology

    Leeds

  • Royal Marsden Hospital-London - Dept of Haematology/Oncology Research

    London

  • The Christie Hospital - Dept of Oncology

    Manchester

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral

  • Mount Vernon Cancer Centre

    Northwood

  • Musgrove Park Hospital - PARENT

    Somerset

  • The Royal Marsden NHS Foundation Trust

    Sutton

  • Torbay Hospital - PARENT

    Torquay

Other trials in United Kingdom

Germany7 sites

  • Vivantes Klinikum Neukoelln - Parent

    Berlin

  • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und Ohrenklinik

    Giessen

  • Universitaetsmedizin Goettingen - Georg-August-Universität

    Göttingen

  • Universitaetsklinikum Jena - HNO_Klinik

    Jena

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie

    Kiel

  • Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie

    Leipzig

  • Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie

    Rostock

Other trials in Germany

Georgia6 sites

  • High Technology Hospital Medcenter LLC

    Batumi

  • JSC EVEX Hospitals

    Kutaisi

  • Cancer Research Center Ltd.

    Tbilisi

  • High Technology Medical Center, University Clinic

    Tbilisi

  • LLC Todua Clinic

    Tbilisi

  • New Hospitals

    Tbilisi

Other trials in Georgia

South Korea6 sites

  • Chonnam National University Hwasun Hospital

    Hwasun-gun

  • Seoul National University Bundang Hospital

    Seongnam

  • Konkuk University Medical Center

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon

  • Pusan National University Yangsan Hospital

    Yangsan

Other trials in South Korea

Argentina5 sites

  • Instituto de Oncologia Angel Roffo

    Ciudad Autonoma Buenos Aires

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja

  • CEMAIC- Centro Medico Privado

    Las Margaritas

  • Fundacion Scherbovsky

    Mendoza

  • Clinica Viedma S.A.

    Viedma

Other trials in Argentina

Romania5 sites

  • Centrul medical Focus

    Bucharest

  • S.C Medisprof S.R.L - parent

    Cluj-Napoca

  • S.C Radiotherapy Center Cluj S.R.L - Parent

    ComunaFloresti

  • S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent

    Craiova

  • S.C Oncocenter Oncologie Clinica S.R.L - parent

    Timișoara

Other trials in Romania

Belgium4 sites

  • Institut Jules Bordet - Medical Oncology

    Anderlecht

  • Cliniques Universitaires Saint-Luc - STL

    Brussels

  • Antwerp University Hospital (UZA Parent)

    Edegem

  • Vitaz

    Sint-Niklaas

Other trials in Belgium

India4 sites

  • Tata Medical Centre

    Kolkata

  • National Cancer Institute Nagpur

    Nagpur

  • All India Institute of Medical Sciences

    New Delhi

  • Regional Cancer Centre

    Thiruvananthapuram

Other trials in India

Israel4 sites

  • Soroka University Medical Center

    Beersheba

  • Rambam Health Care Campus

    Haifa

  • Hadassah University Hospital - Ein Kerem

    Jerusalem

  • Chaim Sheba Medical Center - pt

    Ramat Gan

Other trials in Israel

Switzerland4 sites

  • Universitaetsspital Basel - Klinik fuer Strahlentherapie und Radioonkologie

    Basel

  • Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovanni

    Bellinzona

  • CHUV, Lausanne University Hospital

    Lausanne

  • Universitaetsspital Zuerich - Parent

    Zurich

Other trials in Switzerland

Austria3 sites

  • Universitatsklinikum Graz

    Graz

  • Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO

    Linz

  • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

    Salzburg

Other trials in Austria

Czechia3 sites

  • Fakultni nemocnice Olomouc - Dept of Onkologicka klinika

    Olomouc

  • Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika

    Prague

  • Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika

    Prague

Other trials in Czechia

Greece3 sites

  • General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens

    Athens

  • University General Hospital "Attikon"

    Athens

  • Interbalkan Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

Mexico3 sites

  • Hospital Civil Fray Antonio Alcalde - O.P.D. Hospital Civil de Guadalajara

    Guadalajara

  • Centro de Atención e Investigación Clínica en Oncología

    Mérida

  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey

Other trials in Mexico

Netherlands3 sites

  • Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology

    Amsterdam

  • Universitair Medisch Centrum Groningen - Cancer Center

    Groningen

  • UMC Utrecht - Dept Medical Oncology

    Utrecht

Other trials in Netherlands

Portugal2 sites

  • Hospital de Braga - Serviço de Oncologia Medica

    Braga

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto

Other trials in Portugal

Canada1 site

  • Centre Hospitalier de l'Universite de Montreal.

    Montreal

Other trials in Canada

Poland1 site

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy - Zakład Medycyny Nuklearnej i Endokrynologii Onkolo

    Gliwice

Other trials in Poland

About this study

Official title: 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)

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.

Being tested
Xevinapant, IMRT, Placebo
Keywords
Adjuvant radiotherapy (RT), Stage III, Stage IVA, Stage IVB, Oral cavity, Oropharynx, Larynx, Hypopharynx, Unfit
Medical subject headings
Head and Neck Neoplasms, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XevinapantDrug

    Also called Debio 1143

    Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle.

  • IMRTRadiation

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

  • PlaceboDrug

    Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle.

Study groups in NCT05386550
Study groupRoleWhat they receive
Xevinapant + IMRTExperimentalParticipants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
Receives: Drug: Xevinapant; Radiation: IMRT
Placebo + IMRTPlacebo comparatorParticipants received 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 with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week 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).
Receives: Radiation: IMRT; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS)

    DFS defined as the time from randomization to the first occurrence of any of the following events: Death from any cause; Objective Disease Recurrence (earlier date of first imaging or biopsy collection confirming event at a DFS assessment): Local or regional relapse which is subsequently confirmed by histopathology unless medically contraindicated or medical risk of biopsy deemed too high: Distant metastases. Confirmation of pathology is recommended in case of solitary metastasis (especially in the lung) after considering potential contraindication and/or medical risk associated with biopsy. DFS time was estimated according to Kaplan-Meier method.

    Measured: Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    Overall Survival was defined as the time from randomization to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

    Measured: Time from randomization to death from any cause, assessed up to 22.7 months

  2. Time to Subsequent Cancer Treatments

    Time to subsequent cancer treatments was defined as the time from randomization to the start for the first new anticancer treatment.

    Measured: Time from randomization to the start of first subsequent cancer treatment, assessed up to 22.7 months

  3. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-related TEAEs

    Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: events that start with onset or worsening (seriousness or severity) dates occurring within the on-treatment periods. TEAEs included both serious and non-serious TEAEs. Related TEAEs are events with relationship missing or related.

    Measured: Time from randomization up to 22.7 months

  4. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score

    The EORTC QLQ-HN35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was "the past week". Items hn1 to hn30 were scored on 4 point Likert type categorical scales ("not at all", "a little", "quite a bit", "very much").Items hn31 to hn35 had a "no/yes" response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.

    Measured: Baseline, Day 64 and End of treatment (Day 134)

  5. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score

    EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.

    Measured: Baseline, Day 64 and End of treatment (Day 134)

  6. Change From Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)

    EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100, where 0 is the worst health you can imagine and 100 is the best health you can imagine.

    Measured: Baseline, Day 64 and End of treatment (Day 134)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start6 Oct 2022
  3. Primary completion27 Aug 2024
  4. Study completion27 Aug 2024

Why it stopped: The study was terminated by sponsor as the development program was discontinued due to outcome of phase III Trilynx study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386550
Sponsor's protocol ID
MS202359_0002
Other IDs
2022-001144-18, 2023-508528-36-00, 2023
Status last verified
Jan 2026
First submitted
17 May 2022
Last updated
19 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Ferris RL, Mehanna H, Schoenfeld JD, Tahara M, Yom SS, Haddad R, Konig A, Witzler P, Bajars M, Tourneau CL. Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design. Future Oncol. 2024 Apr;20(12):739-748. doi: 10.2217/fon-2023-0774. Epub 2024 Jan 10.

    PubMed 38197296

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xevinapant and IMRT in people with Head and Neck Cancer, run by EMD Serono Research & Development Institute, Inc. at 206 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 206 sites in China, France, Japan, Brazil, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386550, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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