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Spots Global Cancer Trial Database for Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

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Trial Identification

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

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)

Study ID: NCT05386550

Study Description

Brief 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 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham - Dept of Radiation Oncology, Birmingham, Alabama, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Montefiore Medical Center Radiology, Bronx, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital ae Long Island, New York, New York, United States

University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States

University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology, Pittsburgh, Pennsylvania, United States

Prisma Health Cancer Institute, ITOR, CRU, Greenville, South Carolina, United States

Instituto de Oncologia Angel Roffo, Ciudad Autonoma Buenos Aires, , Argentina

Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina

CEMAIC- Centro Medico Privado, Las Margaritas, , Argentina

Fundacion Scherbovsky, Mendoza, , Argentina

Clinica Viedma S.A., Viedma, , Argentina

Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO, Linz, , Austria

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

Institut Jules Bordet - Medical Oncology, Anderlecht, , Belgium

Cliniques Universitaires Saint-Luc - STL, Bruxelles, , Belgium

Antwerp University Hospital (UZA Parent), Edegem, , Belgium

Vitaz, Sint-Niklaas, , Belgium

Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor, Barretos, , Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba, , Brazil

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica, Florianópolis, , Brazil

CRIO - Centro Regional Integrado de Oncologia, Fortaleza, , Brazil

Oncosite - Centro de Pesquisa Clinica e Oncologia, Ijui, , Brazil

Instituto de Cancer de Londrina, Londrina, , Brazil

Liga Norte-Rio-Grandense Contra o Câncer, Natal, , Brazil

HGB - Hospital Giovanni Battista - Mãe de Deus Center, Porto Alegre, , Brazil

Hospital de Clínicas de Porto Alegre, Porto Alegre, , Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, , Brazil

Grupo Oncoclínicas, Rio de Janeiro, , Brazil

INCA - Instituto Nacional de Câncer, Rio de Janeiro, , Brazil

Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia, Salvador, , Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo André, , Brazil

BP A Beneficencia Portuguesa da Sao Paulo, São Paulo, , Brazil

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

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

Centre Hospitalier de l'Universite de Montreal., Montreal, , Canada

Beijing Cancer Hospital, Beijing, , China

Hospital of Bengbu Medical College, Bengbu, , China

The First Hospital of Jilin University, Changchun, , China

Hunan Cancer Hospital, Changsha, , China

Xiangya Hospital, Central South University, Changsha, , China

Sichuan Cancer Hospital, Chengdu, , China

West China Hospital, Sichuan University, Chengdu, , China

Chongqing University Cancer Hospital, Chongqing, , China

Fujian Cancer Hospital, Fuzhou, , China

Sun Yat-sen University Cancer Center, Guangzhou, , China

Sir Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, , China

Zhejiang Cancer Hospital, Hangzhou, , China

Anhui Provincial Cancer Hospital, Hefei, , China

Shandong Cancer Hospital, Jinan, , China

Jiangxi Cancer Hospital, Nanchang, , China

Nanjing Drum Tower Hospital, Nanjing, , China

Guangxi Medical University Affiliated Tumor Hospital, Nanning, , China

Fudan University Shanghai Cancer Center, Shangai, , China

Shanghai General Hospital, Shanghai, , China

Shengjing Hospital of China Medical University, Shenyang, , China

Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China

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

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

Northern Jiangsu People's Hospital, Yangzhou, , China

Henan Cancer Hospital, Zhengzhou, , China

Fakultni nemocnice Olomouc - Dept of Onkologicka klinika, Olomouc, , Czechia

Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika, Praha 10, , Czechia

Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika, Praha, , Czechia

ICO - Site Paul Papin - service d'oncologie medicale, Angers Cedex 2, , France

CHU Bordeaux - Service d'Oncologie Médicale, Bordeaux, , France

CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale, Brest Cedex, , France

Centre Francois Baclesse - Service d'Oncologie Medicale, Caen Cedex 05, , France

Centre Georges François Leclerc - Oncologie Médicale, Dijon, , France

Hopital Prive Drome Ardeche - Service D Oncologie, Guilherand Granges, , France

Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale, Le Mans Cedex 02, , France

Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale, Le Mans, , France

Centre Oscar Lambret - service de cancerologie gynecologique, Lille cedex, , France

Centre Hospitalier de Bretagne Sud, Lorient cedex, , France

Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale, Lyon, , France

Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs, Marseille Cedex 5, , France

Institut Régional du Cancer de Montpellier - Service de Professeur Senesse, Montpellier, , France

Centre Azureen Cancerologie - Service De Radiotherapie, Mougins, , France

Centre Antoine Lacassagne - Service d'Hématologie Oncologie, Nice cedex 02, , France

Institut Curie - site de Paris - Service d'Oncologie Médicale, Paris Cedex 05, , France

Hopital Tenon - service radiologie et imagerie medicale, Paris cedex, , France

CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale, Poitiers, , France

Centre Henri Becquerel - Service de radiothérapie, Rouen, , France

Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie, Saint Grégoire, , France

ICO - Site René Gauducheau - Service d'Oncologie medicale, Saint Herblain, , France

Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale, Strasbourg Cedex, , France

CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie, Toulon cedex, , France

Institut Claudius Regaud - service de Radiothérapie, Toulouse cedex 09, , France

CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale, Tours, , France

Institut Gustave Roussy - Oncologie Médicale, Villejuif cedex, , France

High Technology Hospital Medcenter LLC, Batumi, , Georgia

JSC EVEX Hospitals, Kutaisi, , Georgia

Cancer Research Center Ltd., Tbilisi, , Georgia

High Technology Medical Center, University Clinic, Tbilisi, , Georgia

LLC Todua Clinic, Tbilisi, , Georgia

New Hospitals, Tbilisi, , Georgia

Vivantes Klinikum Neukoelln - Parent, Berlin, , Germany

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

Universitaetsmedizin Goettingen - Georg-August-Universität, Goettingen, , Germany

Universitaetsklinikum Jena - HNO_Klinik, Jena, , Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie, Kiel, , Germany

Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie, Leipzig, , Germany

Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie, Rostock, , Germany

General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens, Athens, , Greece

University General Hospital "Attikon", Athens, , Greece

Interbalkan Hospital of Thessaloniki, Thessaloniki, , Greece

Tata Medical Centre, Kolkata, , India

National Cancer Institute Nagpur, Nagpur, , India

All India Institute of Medical Sciences, New Delhi, , India

Regional Cancer Centre, Thiruvananthapuram, , India

Soroka University Medical Center, Beer sheva, , Israel

Rambam Health Care Campus, Haifa, , Israel

Chaim Sheba Medical Center - pt, Ramat Gan, , Israel

Hadassah University Hospital - Ein Kerem, Yerushalayim, , Israel

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

Ospedale Oncologico Armando Businco - Divisione di Oncologia Medica II, Cagliari, , Italy

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

Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica, Firenze, , Italy

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

Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo, Milano, , Italy

IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica, Milano, , Italy

Ospedale San Raffaele - U.O. di Oncologia Medica, Milano, , Italy

A.O.U. Policlinico di Modena - U.O. Oncologia, Modena, , Italy

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia, Napoli, , Italy

Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A, Napoli, , Italy

IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2, Padova, , 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, Roma, , Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1, Roma, , Italy

Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia, Rozzano, , Italy

Hyogo Cancer Center - Dept of Head and Neck Surgery, Akashi-shi, , Japan

National Cancer Center Hospital - Dept of Gastroenterology, Chuo-ku, , Japan

NHO Kyushu Cancer Center - Dept of Head and Neck Surgery, Fukuoka-shi, , Japan

Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery, Hidaka-shi, , Japan

Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery, Hiroshima-shi, , Japan

National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology, Kashiwa-shi, , Japan

Kagawa University Hospital - Dept of Oncology, Kita-gun, , Japan

Saitama Cancer Center - Dept of Head and Neck Surgery, Kitaadachi-gun, , Japan

Kobe University Hospital - Dept of Oncology/Hematology, Kobe-shi, , Japan

Cancer Institute Hospital of JFCR - Dept of Medical Oncology, Koto-ku, , Japan

NHO Shikoku Cancer Center - Dept of Head and Neck Surgery, Matsuyama-shi, , Japan

Aichi Cancer Center Hospital - Dept of Head and Neck Surgery, Nagoya-shi, , Japan

Nagoya University Hospital - Dept of Otorhinolaryngology, Nagoya-shi, , Japan

Okayama University Hospital - Dept of Otorhinolaryngology, Okayama-shi, , Japan

Osaka International Cancer Institute - Dept of Head and Neck Surgery, Osaka-shi, , Japan

Kindai University Hospital - Dept of Oncology, Osakasayama-shi, , Japan

Hokkaido University Hospital - Dept of Otorhinolaryngology, Sapporo-shi, , Japan

NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery, Sapporo-shi, , Japan

Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery, Sendai-shi, , Japan

Yokohama City University Hospital - Dept of Otorhinolaryngology, Yokohama-shi, , Japan

Chonnam National University Hwasun Hospital, Hwasun-gun, , Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of

Konkuk University Medical Center, Seoul, , Korea, Republic of

Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of

The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, , Korea, Republic of

Pusan National University Yangsan Hospital, Yangsan-si, , Korea, Republic of

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

Centro de Atención e Investigación Clínica en Oncología, Merida, , Mexico

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

Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology, Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen - Cancer Center, Groningen, , Netherlands

UMC Utrecht - Dept Medical Oncology, Utrecht, , Netherlands

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

Hospital de Braga - Serviço de Oncologia Medica, Braga, , Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto, , Portugal

Centrul medical Focus, Bucuresti, , Romania

S.C Medisprof S.R.L - parent, Cluj-Napoca, , Romania

S.C Radiotherapy Center Cluj S.R.L - Parent, ComunaFloresti, , Romania

S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent, Craiova, , Romania

S.C Oncocenter Oncologie Clinica S.R.L - parent, Timisoara, , Romania

Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera, A Coruña, , Spain

Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia, A Coruña, , Spain

Hospital Clinic de Barcelona - Medical Oncology, Barcelona, , Spain

Hospital del Mar - Servicio de Oncologia, Barcelona, , Spain

Hospital Universitari Vall d'Hebron - Oncology Dept., 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, Barcelona, , Spain

Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia, Las Palmas de Gran Canaria, , Spain

Hospital Universitario Lucus Augusti - Oncology, Lugo, , Spain

Clinica Universidad de Navarra (MAD) - Oncology Service, Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz - Oncology, Madrid, , Spain

Hospital Universitario La Paz - Oncology Department, Madrid, , Spain

Hospital Regional Universitario de Malaga - Oncology Dept, Málaga, , Spain

Hospital Universitario Virgen del Rocio - Oncology Service, Sevilla, , Spain

Universitaetsspital Basel - Klinik fuer Strahlentherapie und Radioonkologie, Basel, , Switzerland

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

CHUV, Lausanne University Hospital, Lausanne, , Switzerland

Universitaetsspital Zuerich - Parent, Zuerich, , Switzerland

Changhua Christian Medical Foundation Changhua Christian Hospital, ChangHua, , Taiwan

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan

China Medical University Hospital, Taichung, , Taiwan

Chi Mei Hospital, Liouying, Tainan, , Taiwan

National Cheng Kung University Hospital, Tainan, , Taiwan

Taipei Veterans General Hospital, Taipei City, , Taiwan

National Taiwan University Hospital, Taipei, , Taiwan

Chang Gung Memorial Hospital,Linkou, Taoyuan, , Taiwan

St James's University Hospital - Dept of Oncology, Leeds, , United Kingdom

Royal Marsden Hospital-London - Dept of Haematology/Oncology Research, London, , United Kingdom

The Christie Hospital - Dept of Oncology, Manchester, , United Kingdom

Mount Vernon Cancer Centre, Northwood, , United Kingdom

Musgrove Park Hospital - PARENT, Somerset, , United Kingdom

The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom

Torbay Hospital - PARENT, Torquay, , United Kingdom

Clatterbridge Cancer Centre, Wirral, , United Kingdom

Contact Details

Name: Medical Responsible

Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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