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
Conditions
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
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