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

January 30, 2026 updated by: EMD Serono Research & Development Institute, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina
        • Instituto de Oncologia Angel Roffo
      • La Rioja, Argentina
        • Centro Oncologico Riojano Integral (Cori)
      • Las Margaritas, Argentina
        • CEMAIC- Centro Medico Privado
      • Mendoza, Argentina
        • Fundación Scherbovsky
      • Viedma, Argentina
        • Clinica Viedma S.A.
  • Austria
      • Graz, Austria
        • Universitätsklinikum Graz
      • Linz, Austria
        • Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO
      • Salzburg, Austria
        • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
  • Belgium
      • Anderlecht, Belgium
        • Institut Jules Bordet - Medical Oncology
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc - STL
      • Edegem, Belgium
        • Antwerp University Hospital (UZA Parent)
      • Sint-Niklaas, Belgium
        • Vitaz
  • Brazil
      • Barretos, Brazil
        • Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor
      • Curitiba, Brazil
        • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
      • Florianópolis, Brazil
        • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica
      • Fortaleza, Brazil
        • Crio - Centro Regional Integrado de Oncologia
      • Ijuí, Brazil
        • Oncosite - Centro de Pesquisa Clinica e Oncologia
      • Londrina, Brazil
        • Instituto de Cancer de Londrina
      • Natal, Brazil
        • Liga Norte-Rio-Grandense Contra O Câncer
      • Porto Alegre, Brazil
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Brazil
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Brazil
        • Hgb - Hospital Giovanni Battista - Mae de Deus Center
      • Rio de Janeiro, Brazil
        • INCA - Instituto Nacional de Cancer
      • Rio de Janeiro, Brazil
        • Grupo Oncoclínicas
      • Salvador, Brazil
        • Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
      • Santo André, Brazil
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
      • São Paulo, Brazil
        • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
      • São Paulo, Brazil
        • BP A Beneficencia Portuguesa da Sao Paulo
  • Canada
      • Montreal, Canada
        • Centre Hospitalier de l'Universite de Montreal.
  • China
      • Beijing, China
        • Beijing Cancer hospital
      • Bengbu, China
        • Hospital of Bengbu Medical College
      • Changchun, China
        • The First Hospital of Jilin University
      • Changsha, China
        • Hunan Cancer Hospital
      • Changsha, China
        • Xiangya Hospital, Central South University
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Chengdu, China
        • Sichuan Cancer Hospital
      • Chongqing, China
        • Chongqing University Cancer Hospital
      • Fuzhou, China
        • Fujian Cancer Hospital
      • Guangzhou, China
        • Sun Yat-sen University Cancer Center
      • Hangzhou, China
        • Zhejiang Cancer Hospital
      • Hangzhou, China
        • Sir Run Shaw Hospital, Zhejiang University, School of Medicine
      • Hefei, China
        • Anhui Provincial Cancer Hospital
      • Jinan, China
        • Shandong Cancer Hospital
      • Nanchang, China
        • Jiangxi Cancer Hospital
      • Nanjing, China
        • Nanjing Drum Tower Hospital
      • Nanning, China
        • Guangxi Medical University Affiliated Tumor Hospital
      • Shanghai, China
        • Fudan University Shanghai Cancer Center
      • Shanghai, China
        • Shanghai General Hospital
      • Shenyang, China
        • Shengjing Hospital Of China Medical University
      • Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital
      • Wuhan, China
        • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
      • Xi'an, China
        • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
      • Yangzhou, China
        • Northern Jiangsu People's Hospital
      • Zhengzhou, China
        • Henan Cancer Hospital
  • Czechia
      • Olomouc, Czechia
        • Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
      • Prague, Czechia
        • Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika
      • Prague, Czechia
        • Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika
  • France
      • Angers, France
        • ICO - Site Paul Papin - service d'oncologie medicale
      • Bordeaux, France
        • CHU Bordeaux - Service d'Oncologie Médicale
      • Brest, France
        • CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale
      • Caen, France
        • Centre Francois Baclesse - Service d'Oncologie Medicale
      • Dijon, France
        • Centre Georges Francois Leclerc - Oncologie Medicale
      • Guilherand-Granges, France
        • Hopital Prive Drome Ardeche - Service D Oncologie
      • Le Mans, France
        • Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale
      • Lille, France
        • Centre Oscar Lambret - service de cancerologie gynecologique
      • Lorient, France
        • Centre Hospitalier de Bretagne Sud
      • Lyon, France
        • Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale
      • Marseille, France
        • Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs
      • Montpellier, France
        • Institut Régional du Cancer de Montpellier - Service de Professeur Senesse
      • Mougins, France
        • Centre Azureen Cancerologie - Service De Radiotherapie
      • Nice, France
        • Centre Antoine Lacassagne - Service d'Hématologie Oncologie
      • Paris, France
        • Institut Curie - site de Paris - Service d'Oncologie Médicale
      • Paris, France
        • Hopital Tenon - service radiologie et imagerie medicale
      • Poitiers, France
        • CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
      • Rouen, France
        • Centre Henri Becquerel - Service de radiothérapie
      • Saint-Grégoire, France
        • Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie
      • Saint-Herblain, France
        • ICO - Site René Gauducheau - Service d'Oncologie medicale
      • Strasbourg, France
        • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
      • Toulon, France
        • CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie
      • Toulouse, France
        • Institut Claudius Regaud - service de Radiothérapie
      • Tours, France
        • CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale
      • Villejuif, France
        • Institut Gustave Roussy - Oncologie Médicale
  • Georgia
      • Batumi, Georgia
        • High Technology Hospital Medcenter LLC
      • Kutaisi, Georgia
        • Jsc Evex Hospitals
      • Tbilisi, Georgia
        • High Technology Medical Center, University Clinic
      • Tbilisi, Georgia
        • New Hospitals
      • Tbilisi, Georgia
        • Llc Todua Clinic
      • Tbilisi, Georgia
        • Cancer Research Center Ltd.
  • Germany
      • Berlin, Germany
        • Vivantes Klinikum Neukoelln - Parent
      • Giessen, Germany
        • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und Ohrenklinik
      • Göttingen, Germany
        • Universitaetsmedizin Goettingen - Georg-August-Universität
      • Jena, Germany
        • Universitaetsklinikum Jena - HNO_Klinik
      • Kiel, Germany
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie
      • Rostock, Germany
        • Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie
  • Greece
      • Athens, Greece
        • University General Hospital "Attikon"
      • Athens, Greece
        • General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens
      • Thessaloniki, Greece
        • Interbalkan Hospital of Thessaloniki
  • India
      • Kolkata, India
        • Tata Medical Centre
      • Nagpur, India
        • National Cancer Institute Nagpur
      • New Delhi, India
        • All India Institute of Medical Sciences
      • Thiruvananthapuram, India
        • Regional Cancer Centre
  • Israel
      • Beersheba, Israel
        • Soroka university medical center
      • Haifa, Israel
        • Rambam Health Care Campus
      • Jerusalem, Israel
        • Hadassah University Hospital - Ein Kerem
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center - pt
  • Italy
      • Brescia, Italy
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica
      • Cagliari, Italy
        • Ospedale Oncologico Armando Businco - Divisione di Oncologia Medica II
      • Candiolo, Italy
        • Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia
      • Florence, Italy
        • Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
      • Meldola, Italy
        • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare
      • Milan, Italy
        • IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica
      • Milan, Italy
        • Ospedale San Raffaele - U.O. di Oncologia Medica
      • Milan, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo
      • Modena, Italy
        • A.O.U. Policlinico di Modena - U.O. Oncologia
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
      • Napoli, Italy
        • Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
      • Padua, Italy
        • IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
      • Roma, Italy
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B
      • Roma, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1
      • Rozzano, Italy
        • Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
  • Japan
      • Akashi-shi, Japan
        • Hyogo Cancer Center - Dept of Head and Neck Surgery
      • Chūōku, Japan
        • National Cancer Center Hospital - Dept of Gastroenterology
      • Fukuoka, Japan
        • NHO Kyushu Cancer Center - Dept of Head and Neck Surgery
      • Hidaka-shi, Japan
        • Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery
      • Hiroshima, Japan
        • Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery
      • Kashiwa-shi, Japan
        • National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology
      • Kita-gun, Japan
        • Kagawa University Hospital - Dept of Oncology
      • Kitaadachi-gun, Japan
        • Saitama Cancer Center - Dept of Head and Neck Surgery
      • Kobe, Japan
        • Kobe University Hospital - Dept of Oncology/Hematology
      • Kōtoku, Japan
        • Cancer Institute Hospital of JFCR - Dept of Medical Oncology
      • Matsuyama, Japan
        • NHO Shikoku Cancer Center - Dept of Head and Neck Surgery
      • Nagoya, Japan
        • Aichi Cancer Center Hospital - Dept of Head and Neck Surgery
      • Nagoya, Japan
        • Nagoya University Hospital - Dept of Otorhinolaryngology
      • Okayama, Japan
        • Okayama University Hospital - Dept of Otorhinolaryngology
      • Osaka, Japan
        • Osaka International Cancer Institute - Dept of Head and Neck Surgery
      • Osakasayama-shi, Japan
        • Kindai University Hospital - Dept of Oncology
      • Sapporo, Japan
        • Hokkaido University Hospital - Dept of Otorhinolaryngology
      • Sapporo, Japan
        • NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery
      • Sendai, Japan
        • Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery
      • Yokohama, Japan
        • Yokohama City University Hospital - Dept of Otorhinolaryngology
  • Mexico
      • Guadalajara, Mexico
        • Hospital Civil Fray Antonio Alcalde - O.P.D. Hospital Civil de Guadalajara
      • Monterrey, Mexico
        • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
      • Mérida, Mexico
        • Centro de Atención e Investigación Clínica en Oncología
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology
      • Groningen, Netherlands
        • Universitair Medisch Centrum Groningen - Cancer Center
      • Utrecht, Netherlands
        • UMC Utrecht - Dept Medical Oncology
  • Poland
      • Gliwice, Poland
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy - Zakład Medycyny Nuklearnej i Endokrynologii Onkolo
  • Portugal
      • Braga, Portugal
        • Hospital de Braga - Serviço de Oncologia Medica
      • Porto, Portugal
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Romania
      • Bucharest, Romania
        • Centrul Medical Focus
      • Cluj-Napoca, Romania
        • S.C Medisprof S.R.L - parent
      • ComunaFloresti, Romania
        • S.C Radiotherapy Center Cluj S.R.L - Parent
      • Craiova, Romania
        • S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent
      • Timișoara, Romania
        • S.C Oncocenter Oncologie Clinica S.R.L - parent
  • South Korea
      • Hwasun-gun, South Korea
        • Chonnam National University Hwasun Hospital
      • Seongnam, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, South Korea
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Konkuk University Medical Center
      • Suwon, South Korea
        • The Catholic university of Korea, St. Vincent's Hospital
      • Yangsan, South Korea
        • Pusan National University Yangsan Hospital
  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia
      • Barcelona, Spain
        • Hospital del Mar - Servicio de Oncologia
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron - Oncology Dept.
      • Barcelona, Spain
        • Hospital Clinic de Barcelona - Medical Oncology
      • Barcelona, Spain
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
      • Barcelona, Spain
        • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
      • Las Palmas de Gran Canaria, Spain
        • Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia
      • Lugo, Spain
        • Hospital Universitario Lucus Augusti - Oncology
      • Madrid, Spain
        • Clinica Universidad de Navarra (MAD) - Oncology Service
      • Madrid, Spain
        • Hospital Universitario Fundacion Jimenez Diaz - Oncology
      • Madrid, Spain
        • Hospital Universitario La Paz - Oncology Department
      • Málaga, Spain
        • Hospital Regional Universitario de Malaga - Oncology Dept
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio - Oncology Service
  • Switzerland
      • Basel, Switzerland
        • Universitaetsspital Basel - Klinik fuer Strahlentherapie und Radioonkologie
      • Bellinzona, Switzerland
        • Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovanni
      • Lausanne, Switzerland
        • Chuv, Lausanne University Hospital
      • Zurich, Switzerland
        • Universitaetsspital Zuerich - Parent
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Tainan, Taiwan
        • Chi Mei Hospital, Liouying
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan
        • Chang Gung Memorial Hospital,Linkou
  • United Kingdom
      • Leeds, United Kingdom
        • St James's University Hospital - Dept of Oncology
      • London, United Kingdom
        • Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
      • Manchester, United Kingdom
        • The Christie Hospital - Dept of Oncology
      • Metropolitan Borough of Wirral, United Kingdom
        • Clatterbridge Cancer Centre
      • Northwood, United Kingdom
        • Mount Vernon Cancer Centre
      • Somerset, United Kingdom
        • Musgrove Park Hospital - PARENT
      • Sutton, United Kingdom
        • The Royal Marsden NHS Foundation Trust
      • Torquay, United Kingdom
        • Torbay Hospital - PARENT
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham - Dept of Radiation Oncology
    • Arizona
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UC Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • New York
      • New York, New York, United States, 10016
        • Perlmutter Cancer Center at NYU Langone Hospital ae Long Island
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center Radiology
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute, ITOR, CRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xevinapant + IMRT
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 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).
Drug: Xevinapant
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.
Other Names:
  • Debio 1143
Radiation: IMRT
Participants received 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days per week.
Placebo Comparator: Placebo + IMRT
Participants 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).
Radiation: IMRT
Participants received 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days per week.
Drug: Placebo
Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Time from randomization to death from any cause, assessed up to 22.7 months
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.
Time from randomization to death from any cause, assessed up to 22.7 months
Time to Subsequent Cancer Treatments
Time Frame: Time from randomization to the start of first subsequent cancer treatment, assessed up to 22.7 months
Time to subsequent cancer treatments was defined as the time from randomization to the start for the first new anticancer treatment.
Time from randomization to the start of first subsequent cancer treatment, assessed up to 22.7 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-related TEAEs
Time Frame: Time from randomization up to 22.7 months
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.
Time from randomization up to 22.7 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score
Time Frame: Baseline, Day 64 and End of treatment (Day 134)
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.
Baseline, Day 64 and End of treatment (Day 134)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score
Time Frame: Baseline, Day 64 and End of treatment (Day 134)
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.
Baseline, Day 64 and End of treatment (Day 134)
Change From Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)
Time Frame: Baseline, Day 64 and End of treatment (Day 134)
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.
Baseline, Day 64 and End of treatment (Day 134)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Actual)

August 27, 2024

Study Completion (Actual)

August 27, 2024

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS202359_0002
  • 2022-001144-18 (EudraCT Number)
  • 2023-508528-36-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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