Spots Global Cancer Trial Database for A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
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Trial Identification
Brief Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
Official Title: A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
Study ID: NCT04459715
Study Description
Brief Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC), Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Regents of the University of California, San Francisco, California, United States
UCSF, San Francisco, California, United States
The Oncology Institute of Hope & Innovation, Whittier, California, United States
University of Colorado at Denver and Health Sciences Center, Aurora, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, District of Columbia, United States
Moffitt Cancer Center, Tampa, Florida, United States
ASCLEPES Research Centers, Weeki Wachee, Florida, United States
Columbus Regional Research Institute, Columbus, Georgia, United States
IACT Health, John B. Amos Cancer Center, Columbus, Georgia, United States
Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Ashland-Bellefonte Cancer Center, Ashland, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University South Hospital, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Karmanos Cancer institute, Detroit, Michigan, United States
University of Missouri - Ellis Fischel Cancer Center, Columbia, Missouri, United States
MidAmerica Cancer Care, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Comprehensive Cancer Center of Nevada (Southern Hills) (USA), Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
NYU Langone Hospital-Long Island Oncology, Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
NYU Grossman School of Medicine, New York, New York, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
University Hospital Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center- Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina- Hollings Cancer Center, Charleston, South Carolina, United States
MD Anderson, Houston, Texas, United States
IHO Corporation/Utah Cancer Specialists, Salt Lake City, Utah, United States
University of Virginia Medical Center, Charlottesville, Virginia, United States
Hospital Aleman, Buenos Aires, , Argentina
Instituto Medico Especialazado Alexander Fleming, Buenos Aires, , Argentina
Clinica Universitaria Reina Fabiola, Cordoba, , Argentina
Instituto de Oncologia de Rosario, Santa Fe, , Argentina
Clinica Viedma, Viedma, , Argentina
Ashford Cancer Centre Research, Tennyson Centre, Adelaide, , Australia
St Vincents Hospital, Darlinghurst, , Australia
St Vincents Hospital Melbourne, Fitzroy, , Australia
Peter MacCallum Cancer Centre, Melbourne, , Australia
Wollongong Hospital, Wollongong, , Australia
Princess Alexandra Hospital, Cancer Trials Unit, Woolloongabba, , Australia
Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde, Graz, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Universitätsklinik für Innere Medizin III der PMU, Salzburg, , Austria
Medical University of Vienna, Department of Medicine I, Division of Oncology, Vienna, , Austria
Cliniques universitaires Saint-Luc, Bruxelles, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent UZ Gent, Gent, , Belgium
Hopital de Jolimont, Rue Ferrer, La Louvière, , Belgium
UZ Leuven, Radiotherapy & Oncology, Leuven, , Belgium
Centre Hospitalier de l'Ardenne (CHA), Libramont, , Belgium
CHU UCL Namur Site Sainte Elisabeth, Namur, , Belgium
A.Z. Nikolaas, Sint-Niklaas, , Belgium
GZA Sint-Augustinus, Wilrijk, , Belgium
Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela, Barretos, , Brazil
Hospital de Caridade de Ijui, Avenida David Jose Martins, Ijuí, , Brazil
Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro, Natal, , Brazil
Centro Gaúcho Integrado, Rua Costa, Porto Alegre, , Brazil
Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer, Porto Alegre, , Brazil
Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer, Porto Alegre, , Brazil
National Cancer Institute, Rio De Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC, Santo André, , Brazil
Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima, São José Do Rio Preto, , Brazil
Instituto do Cancer do Estado de Sao Paulo (ICESP), São Paulo, , Brazil
Oswaldo Cruz German Hospital, São Paulo, , Brazil
London Regional Cancer Program, London Health Sciences Centre, London, , Canada
CHU Montréal, Montreal, , Canada
CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont, Montreal, , Canada
Hopital Maisonneuve-Rosemont, Montreal, , Canada
CHU de Quebec-Université Laval, Québec, , Canada
Sunnybrook Research Institute, Toronto, , Canada
Beijing Cancer Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
Xiangya Hospital Central South University, Changsha, , China
West China Hospital of Sichuan University, Chengdu, , China
Fujian Cancer Hospital, Fuzhou, , China
The 5th Affiliated Hospital of Sun yet-sen university, Guangdong, , China
The 2nd Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Province Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Affiliated Tumor Hospital of Guangxi Medical University, Nanning, , China
Lin Yi Cancer Hospital, Shandong, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Shanghai Ninth People's Hospital, Shanghai, , China
Shantou University Cancer Hospital, Shantou, , China
Liaoning Cancer Hospital & institute, Shenyang, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Tongji Hospital/Tongji Medical College, Huazhong University of Science, Wuhan, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
University Hospital hradec Kralové, Hradec Králové, , Czechia
Fakultni Nemocnice Ostrava, Ostrava-Poruba, , Czechia
Hospital Na Bulovce, Prague, , Czechia
KOC KNTB a.s. Zlín, Zlín, , Czechia
CHU Amiens Picardie - Hopital Sud, Amiens, , France
Institut de Cancérologie de l Ouest (ICO), Angers, , France
Institut Sainte Catherine, Avignon Cedex 9, , France
Centre hospitalier Universitaire de Bordeaux, Bordeaux, , France
CHRU de Brest Hopital Morvan, Brest, , France
Centre Jean Perrin CLCC, Clermont Ferrand, , France
CHU de Grenoble, Grenoble Cedex 9, , France
Centre Guillaume Le Conquerant, le Havre, , France
Clinique Victor Hugo, Le Mans, , France
Centre hospitalier Libourne, Libourne, , France
Centre Oscar Lambret, Lille, , France
Hôpital du Scorff, Lorient, , France
Centre Leon Berard, Lyon, , France
Service d'Oncologie Médicale, CHU Timone, Marseille, , France
Hôpital Nord Franche Comté, Montbeliard, , France
Institut Regional du Cancer de Montpellier, Montpellier, , France
LHopital prive du Confluent Nantes, Nantes Cedex 2, , France
CCConcorde (GCS), Neuilly sur Seine, , France
Centre Antoine Lacassagne, Nice, , France
CHU Nimes, Nimes, , France
Institut Curie, Paris, , France
Centre Eugène Marquis, Rennes Cedex, , France
Centre Henri Becquerel CLCC, Rouen Cedex, , France
CHP Saint Gregoire FINESS, Saint Gregoire, , France
Institut de Cancérologie de l'Ouest - Site Saint Herblain, Saint Herblain, , France
ICANS, Strasbourg, , France
Institut Claudius Regaud - IUCT-O, Toulouse, , France
CHU de Tours, Tours, , France
The Public Hospital L'Institut de Cancerologie de Lorraine, Vandoeuvre les Nancy, , France
Institut Gustave Roussy - Service de radiotherapie, Villejuif, , France
Evex Hospitals Oncology Center, Kutaisi, , Georgia
Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine, Tbilisi, , Georgia
Cancer Research Cent 4, Tbilisi, , Georgia
Institute of Clinical Oncology, Tbilisi, , Georgia
JSC "Evex Hospitals", Tbilisi, , Georgia
LEPL First University Clinic of Tbilisi State Medical University, Tbilisi, , Georgia
New Hospitals, Tbilisi, , Georgia
CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie, Berlin, , Germany
Charité - Universitätsmedizin Berlin Campus Virchow, Berlin, , Germany
Strahlenklinik des Uni-Klinikums, Erlangen, , Germany
Department of radiation oncology, University Hospital Essen, Essen, , Germany
Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie, Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, , Germany
Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie, Leipzig, , Germany
Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie, Mannheim, , Germany
Universitaetsklinikum Regensburg, Regensburg, , Germany
Universitaetsmedizin Rostock, Rostock, , Germany
Agioi Anargiroi General Oncology Hospital of Kifissia, Athens, , Greece
Attikon University Hospital, Athens, , Greece
Theagenio Anticancer Hospital, Thessaloníki, , Greece
Orszagos Onkologiai Intezet Sugarterapias Osztaly, Budapest, , Hungary
Uzsoki Utcai Korhaz Onkologiai Osztaly, Budapest, , Hungary
Petz Aladár Megyei Kórház Onkoradiológiai Osztály, Győr, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet, Pécs, , Hungary
Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika, Szeged, , Hungary
Rambam Healthcare Campus, Haifa, , Israel
Research Fund of the Hadassah Medical Organization, Jerusalem, , Israel
Rabin Medical Center, Petach Tiqva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Centro di Riferimento Oncologico, Aviano, , Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia, Brescia, , Italy
Istituto di Candiolo IRCCS, Candiolo, , Italy
Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle, Cuneo, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
IRCCS AOU San Martino, Genova, , Italy
Ospedale "Vito Fazzi" Lecce, Lecce, , Italy
Az. USL 6 Ospedali Riuniti-Ospedale di Livorno, Livorno, , Italy
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, , Italy
IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO, Milan, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Policlinico di Modena, Modena, , Italy
AORN Ospedale dei Monaldi, Napoli, , Italy
AOU "Luigi Vanvitelli", Napoli, , Italy
Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale", Napoli, , Italy
Istituto Oncologico Veneto Irccs, Padova, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Rome, , Italy
ASL2_Presidio Ospedaliero San Paolo, Savona, , Italy
National Cancer Center Hospital East, Chiba, , Japan
National Cancer Center Hospital, Chuo-ku Tokyo, , Japan
Saitama Medical University International Medical Center, Hidaka, , Japan
Hyogo Cancer Center, Hyogo, , Japan
University Hospital Kyoto Prefectural University of Medicine, Kamigyo-ku, , Japan
Tokai University Hospital, Kanagawa, , Japan
Hokkaido University Hospital, Kita-Ku, , Japan
Okayama University Hospital, Kita-ku, , Japan
Kobe University Hospital, Kobe, , Japan
Cancer Institute Hospital of JFCR, Koto-ku, , Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, , Japan
Shizuoka Cancer Center, Nagaizumi-cho, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Tokyo Medical University Hospital, Tokyo, , Japan
Pusan National University Hospital, Busan, , Korea, Republic of
National Cancer Center Hematologic Oncology, Goyang-si, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Asan Medical Center, Asian Cacer Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
KonKuk University Medical Center, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Boramae Medical Center, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Oncol & Hematology, Yangsan, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii, Gdańsk, , Poland
Szpitale Pomorskie Sp. z o.o., Gdynia, , Poland
Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach, Gliwice, , Poland
SP ZOZ MSWiA z W-M CO w Olsztynie, Olsztyn, , Poland
NZOZ Provita Prolife Centrum Medyczne, Łódź, , Poland
Centro Clinico Academico, Braga, , Portugal
Hospital de Braga, Braga, , Portugal
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE, Coimbra, , Portugal
Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT), Faro, , Portugal
Centro Hospitalar Universitário Lisboa Norte, Lissabon, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, Porto, , Portugal
Centro Hospitalar Universitario São João, Porto, , Portugal
Hospital Pedro Hispano, Porto, , Portugal
Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E, Porto, , Portugal
State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan", Kazan, , Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky, Krasnoyarsk, , Russian Federation
Kursk Regional Clinical Oncology Dispensary, Kursk, , Russian Federation
FGBU N.N.Blokhin Russian Cancer Research Center, Moscow, , Russian Federation
EuroCityClinic, Saint Petersburg, , Russian Federation
Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology), Saint Petersburg, , Russian Federation
FSBI National Med Research Cancer Center N.N. Petrov, Saint-Petersburg, , Russian Federation
Republican Clinical Oncological Dispensary of Bashkortostan, Ufa, , Russian Federation
State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS), Ufa, , Russian Federation
State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital, Yaroslavl, , Russian Federation
Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro", A Coruña, Galicia, Spain
Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro, A Coruna, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Català d'Oncologia Badalona, Barcelona, , Spain
Institut Català d'Oncologia, Hospital Duran, Barcelona, , Spain
Institut Universitari Dexeus-Quiron (ESP), Barcelona, , Spain
Hospital Reina Sofía, Cordoba, , Spain
Institut Català d'Oncologia, Girona, , Spain
Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Althaia, Xarxa Assistencial, Manresa, , Spain
Fundacio Althaia, Manresa, , Spain
Hospital Civil (Hospital Regional Universitario), Málaga, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario Marqués de Valdecilla. Santander, Santander, , Spain
Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP), Valencia, , Spain
Hospital Universitario La Fe, Valencia, , Spain
IVO, Valencia, , Spain
Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie, Bern, , Switzerland
Hopitaux Universitaires de Geneve, Geneve, , Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, , Switzerland
Chang-Gung Memorial Hospital-Kaohsiung, Kaohsiung City, , Taiwan
Kaohsiung Medical University Memorial Hospital, Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital (VGHTP), Taipei, , Taiwan
Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital, Taoyuan City, , Taiwan
Medical center ASKLEPION LLC, Khodosivka, , Ukraine
Kiev City Clinical Oncology Centre, Kiev, , Ukraine
Medical center of Yuriy Spizhenko, Soborna Vulytsia, Kyiv, , Ukraine
Aberdeen Royal infirmary, Dept. of Oncology, Aberdeen, , United Kingdom
Royal Marsden NHS Foundation Trust, Chelsea, , United Kingdom
NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom
Royal Surrey County Hospital, Guildford, , United Kingdom
Charing Cross Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Mount Vernon Cancer Centre, Northwood, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
The Royal Marsden NHS Foundation Trust - Sutton, Sutton, , United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust, 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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