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)

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Intervention / Treatment: Drug: Xevinapant (Debio 1143); Drug: Cisplatin; Radiation: Intensity Modulation Radiation Therapy (IMRT); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 730
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Aleman
  • Buenos Aires, Argentina
    • Instituto Medico Especialazado Alexander Fleming
  • Cordoba, Argentina
    • Clinica Universitaria Reina Fabiola
  • Santa Fe, Argentina
    • Instituto de Oncologia de Rosario
  • Viedma, Argentina
    • Clinica Viedma
• Australia
  • Adelaide, Australia
    • Ashford Cancer Centre Research, Tennyson Centre
  • Darlinghurst, Australia
    • St Vincents Hospital
  • Fitzroy, Australia
    • St Vincents Hospital Melbourne
  • Melbourne, Australia
    • Peter MacCallum Cancer Centre
  • Wollongong, Australia
    • Wollongong Hospital
  • Woolloongabba, Australia
    • Princess Alexandra Hospital, Cancer Trials Unit
• Austria
  • Graz, Austria
    • Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde
  • Salzburg, Austria
    • Landeskrankenhaus Salzburg
  • Salzburg, Austria
    • Universitätsklinik für Innere Medizin III der PMU
  • Vienna, Austria
    • Medical University of Vienna, Department of Medicine I, Division of Oncology
• Belgium
  • Bruxelles, Belgium
    • Cliniques Universitaires Saint-Luc
  • Charleroi, Belgium
    • Grand Hopital de Charleroi
  • Edegem, Belgium
    • Universitair Ziekenhuis Antwerpen
  • Gent, Belgium
    • Universitair Ziekenhuis Gent UZ Gent
  • La Louvière, Belgium
    • Hopital de Jolimont, Rue Ferrer
  • Leuven, Belgium
    • UZ Leuven, Radiotherapy & Oncology
  • Libramont, Belgium
    • Centre Hospitalier de l'Ardenne (CHA)
  • Namur, Belgium
    • CHU UCL Namur Site Sainte Elisabeth
  • Sint-Niklaas, Belgium
    • A.Z. Nikolaas
  • Wilrijk, Belgium
    • GZA Sint-Augustinus
• Brazil
  • Barretos, Brazil
    • Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
  • Ijuí, Brazil
    • Hospital de Caridade de Ijui, Avenida David Jose Martins
  • Natal, Brazil
    • Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
  • Porto Alegre, 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
  • Rio De Janeiro, Brazil
    • National Cancer Institute
  • Santo André, Brazil
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC
  • São José Do Rio Preto, Brazil
    • Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
  • São Paulo, Brazil
    • Instituto do Cancer do Estado de São Paulo (ICESP)
  • São Paulo, Brazil
    • Oswaldo Cruz German Hospital
• Canada
  • London, Canada
    • London Regional Cancer Program, London Health Sciences Centre
  • Montreal, Canada
    • CHU Montreal
  • Montreal, Canada
    • CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont
  • Montreal, Canada
    • Hôpital Maisonneuve-Rosemont
  • Québec, Canada
    • CHU de Quebec-Universite Laval
  • Toronto, Canada
    • Sunnybrook Research Institute
• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Changchun, China
    • Jilin Cancer Hospital
  • Changsha, China
    • Xiangya Hospital Central South University
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Fuzhou, China
    • Fujian Cancer Hospital
  • Guangdong, China
    • The 5th Affiliated Hospital of Sun yet-sen university
  • Hangzhou, China
    • The 2nd Affiliated Hospital of Zhejiang University School of Medicine
  • Hangzhou, China
    • Zhejiang Province Cancer Hospital
  • Harbin, China
    • Harbin Medical University Cancer Hospital
  • Nanning, China
    • Affiliated Tumor Hospital of Guangxi Medical University
  • Shandong, China
    • Lin Yi Cancer Hospital
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Shanghai, China
    • Shanghai Ninth People's Hospital
  • Shantou, China
    • Shantou University Cancer Hospital
  • Shenyang, China
    • Liaoning Cancer Hospital & Institute
  • Tianjin, China
    • Tianjin Medical University Cancer Institute & Hospital
  • Wuhan, China
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan, China
    • Tongji Hospital/Tongji Medical College, Huazhong University of Science
  • Zhengzhou, China
    • Henan Cancer Hospital
• Czechia
  • Hradec Králové, Czechia
    • University Hospital Hradec Kralove
  • Ostrava-Poruba, Czechia
    • Fakultni nemocnice Ostrava
  • Prague, Czechia
    • Hospital Na Bulovce
  • Zlín, Czechia
    • KOC KNTB a.s. Zlín
• France
  • Amiens, France
    • CHU Amiens Picardie - Hopital Sud
  • Angers, France
    • Institut de Cancérologie de l Ouest (ICO)
  • Avignon Cedex 9, France
    • Institut Sainte Catherine
  • Bordeaux, France
    • Centre hospitalier Universitaire de Bordeaux
  • Brest, France
    • CHRU de Brest Hôpital Morvan
  • Clermont Ferrand, France
    • Centre Jean Perrin CLCC
  • Grenoble Cedex 9, France
    • CHU de Grenoble
  • Le Mans, France
    • Clinique Victor Hugo
  • Libourne, France
    • Centre hospitalier Libourne
  • Lille, France
    • Centre Oscar Lambret
  • Lorient, France
    • Hôpital du Scorff
  • Lyon, France
    • Centre Leon Berard
  • Marseille, France
    • Service d'Oncologie Médicale, CHU Timone
  • Montbeliard, France
    • Hôpital Nord Franche Comté
  • Montpellier, France
    • Institut Régional du Cancer de Montpellier
  • Nantes Cedex 2, France
    • LHopital prive du Confluent Nantes
  • Neuilly sur Seine, France
    • CCConcorde (GCS)
  • Nice, France
    • Centre Antoine Lacassagne
  • Nimes, France
    • Chu Nimes
  • Paris, France
    • Institut Curie
  • Rennes Cedex, France
    • Centre Eugene Marquis
  • Rouen Cedex, France
    • Centre Henri Becquerel CLCC
  • Saint Gregoire, France
    • CHP Saint Gregoire FINESS
  • Saint Herblain, France
    • Institut de Cancérologie de l'Ouest - Site Saint Herblain
  • Strasbourg, France
    • ICANS
  • Toulouse, France
    • Institut Claudius Regaud - IUCT-O
  • Tours, France
    • CHU de Tours
  • Vandoeuvre les Nancy, France
    • The Public Hospital L'Institut de Cancerologie de Lorraine
  • Villejuif, France
    • Institut Gustave Roussy - Service de radiotherapie
  • le Havre, France
    • Centre Guillaume le Conquérant
• Georgia
  • Kutaisi, Georgia
    • Evex Hospitals Oncology Center
  • Tbilisi, Georgia
    • Institute Of Clinical Oncology
  • Tbilisi, Georgia
    • Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
  • Tbilisi, Georgia
    • Cancer Research Cent 4
  • Tbilisi, Georgia
    • JSC "Evex Hospitals"
  • Tbilisi, Georgia
    • LEPL First University Clinic of Tbilisi State Medical University
  • Tbilisi, Georgia
    • New Hospitals
• Germany
  • Berlin, Germany
    • CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin Campus Virchow
  • Erlangen, Germany
    • Strahlenklinik des Uni-Klinikums
  • Essen, Germany
    • Department of radiation oncology, University Hospital Essen
  • Essen, Germany
    • Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Kiel, Germany
    • University Medical Center Schleswig-Holstein, Campus Kiel
  • Leipzig, Germany
    • Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie
  • Mannheim, Germany
    • Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
  • Regensburg, Germany
    • Universitaetsklinikum Regensburg
  • Rostock, Germany
    • Universitaetsmedizin Rostock
• Greece
  • Athens, Greece
    • Attikon University Hospital
  • Athens, Greece
    • Agioi Anargiroi General Oncology Hospital of Kifissia
  • Thessaloníki, Greece
    • Theagenio Anticancer Hospital
• Hungary
  • Budapest, Hungary
    • Orszagos Onkologiai Intezet Sugarterapias Osztaly
  • Budapest, Hungary
    • Uzsoki Utcai Korhaz Onkologiai Osztaly
  • Győr, Hungary
    • Petz Aladár Megyei Kórház Onkoradiológiai Osztály
  • Pécs, Hungary
    • Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet
  • Szeged, Hungary
    • Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika
• Israel
  • Haifa, Israel
    • Rambam Healthcare Campus
  • Jerusalem, Israel
    • Research Fund of the Hadassah Medical Organization
  • Petach Tiqva, Israel
    • Rabin Medical Center
  • Ramat Gan, Israel
    • Sheba Medical Center
• Italy
  • Aviano, Italy
    • Centro Di Riferimento Oncologico
  • Brescia, Italy
    • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
  • Candiolo, Italy
    • Istituto Di Candiolo Irccs
  • Cuneo, Italy
    • Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle
  • Firenze, Italy
    • Azienda Ospedaliero-Universitaria Careggi
  • Genova, Italy
    • IRCCS AOU San Martino
  • Lecce, Italy
    • Ospedale "Vito Fazzi" Lecce
  • Livorno, Italy
    • Az. USL 6 Ospedali Riuniti-Ospedale di Livorno
  • Meldola, Italy
    • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
  • Milan, Italy
    • Istituto Nazionale dei Tumori
  • Milan, Italy
    • IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO
  • Modena, Italy
    • Policlinico di Modena
  • Napoli, Italy
    • AORN Ospedale dei Monaldi
  • Napoli, Italy
    • AOU "Luigi Vanvitelli"
  • Napoli, Italy
    • Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale"
  • Padova, Italy
    • Istituto Oncologico Veneto IRCCS
  • Parma, Italy
    • Azienda Ospedaliero Universitaria di Parma
  • Rome, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli
  • Savona, Italy
    • ASL2_Presidio Ospedaliero San Paolo
• Japan
  • Chiba, Japan
    • National Cancer Center Hospital East
  • Chuo-ku Tokyo, Japan
    • National Cancer Center Hospital
  • Hidaka, Japan
    • Saitama Medical University International Medical Center
  • Hyogo, Japan
    • Hyogo Cancer Center
  • Kamigyo-ku, Japan
    • University Hospital Kyoto Prefectural University of Medicine
  • Kanagawa, Japan
    • Tokai University Hospital
  • Kita-Ku, Japan
    • Hokkaido University Hospital
  • Kita-ku, Japan
    • Okayama University Hospital
  • Kobe, Japan
    • Kobe University Hospital
  • Koto-ku, Japan
    • Cancer Institute Hospital of JFCR
  • Matsuyama, Japan
    • National Hospital Organization Shikoku Cancer Center
  • Nagaizumi-cho, Japan
    • Shizuoka Cancer Center
  • Osaka, Japan
    • Osaka International Cancer Institute
  • Tokyo, Japan
    • Tokyo Medical University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Goyang-si, Korea, Republic of
    • National Cancer Center
  • Goyang-si, Korea, Republic of
    • National Cancer Center Hematologic Oncology
  • 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
    • Asan Medical Center, Asian Cacer Center
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital, Oncol & Hematology
• Poland
  • Gdańsk, Poland
    • Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii
  • Gdynia, Poland
    • Szpitale Pomorskie Sp. z o.o.
  • Gliwice, Poland
    • Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
  • Olsztyn, Poland
    • SP ZOZ MSWiA z W-M CO w Olsztynie
  • Łódź, Poland
    • NZOZ Provita Prolife Centrum Medyczne
• Portugal
  • Braga, Portugal
    • Hospital de Braga
  • Braga, Portugal
    • Centro Clinico Academico
  • Coimbra, Portugal
    • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
  • Faro, Portugal
    • Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)
  • Lissabon, Portugal
    • Centro Hospitalar Universitário Lisboa Norte
  • Porto, Portugal
    • Hospital Pedro Hispano
  • Porto, Portugal
    • Centro Hospitalar Universitario Sao Joao
  • Porto, Portugal
    • Centro Hospitalar de Vila Nova de Gaia/Espinho
  • Porto, Portugal
    • Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E
• Russian Federation
  • Kazan, Russian Federation
    • State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"
  • Krasnoyarsk, Russian Federation
    • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky
  • Kursk, Russian Federation
    • Kursk Regional Clinical Oncology Dispensary
  • Moscow, Russian Federation
    • FGBU N.N.Blokhin Russian Cancer Research Center
  • Saint Petersburg, 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
  • Ufa, Russian Federation
    • Republican Clinical Oncological Dispensary of Bashkortostan
  • Ufa, Russian Federation
    • State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)
  • Yaroslavl, Russian Federation
    • State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital
• Spain
  • A Coruna, Spain
    • Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Clinic Barcelona
  • Barcelona, Spain
    • Institut Català d'Oncologia Badalona
  • Barcelona, Spain
    • Institut Català d'Oncologia, Hospital Duran
  • Barcelona, Spain
    • Institut Universitari Dexeus-Quiron (ESP)
  • Cordoba, Spain
    • Hospital Reina Sofía
  • Girona, Spain
    • Institut Català d'Oncologia
  • Las Palmas de Gran Canaria, Spain
    • Hospital Universitario Insular de Gran Canaria
  • Madrid, Spain
    • Hospital Ramón y Cajal
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Clinica Universidad de Navarra
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario HM Sanchinarro
  • Manresa, Spain
    • Fundacio Althaia
  • Manresa, Spain
    • Althaia, Xarxa Assistencial
  • Málaga, Spain
    • Hospital Civil (Hospital Regional Universitario)
  • Pamplona, Spain
    • Clinica Universidad de Navarra
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla. Santander
  • Valencia, Spain
    • Hospital Universitario La Fe
  • Valencia, Spain
    • Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)
  • Valencia, Spain
    • IVO
  • Galicia
    • A Coruña, Galicia, Spain
      • Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro"
• Switzerland
  • Bern, Switzerland
    • Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
  • Geneve, Switzerland
    • Hopitaux Universitaires de Geneve
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois Lausanne
• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Memorial Hospital
  • Kaohsiung City, Taiwan
    • Chang-Gung Memorial Hospital-Kaohsiung
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taichung City, Taiwan
    • Taichung Veterans General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital (VGHTP)
  • Taoyuan City, Taiwan
    • Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital
• Ukraine
  • Khodosivka, Ukraine
    • Medical Center Asklepion Llc
  • Kiev, Ukraine
    • Kiev City Clinical Oncology Centre
  • Kyiv, Ukraine
    • Medical center of Yuriy Spizhenko, Soborna Vulytsia
• United Kingdom
  • Aberdeen, United Kingdom
    • Aberdeen Royal infirmary, Dept. of Oncology
  • Chelsea, United Kingdom
    • Royal Marsden NHS Foundation Trust
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde
  • Guildford, United Kingdom
    • Royal Surrey County Hospital
  • London, United Kingdom
    • Charing Cross Hospital
  • Manchester, United Kingdom
    • The Christie NHS Foundation Trust
  • Northwood, United Kingdom
    • Mount Vernon Cancer Centre
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust
  • Southampton, United Kingdom
    • University Hospital Southampton NHS Foundation Trust
  • Sutton, United Kingdom
    • The Royal Marsden Nhs Foundation Trust - Sutton
  • Wirral, United Kingdom
    • Clatterbridge Cancer Centre NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • San Francisco, California, United States, 94158
      • UCSF
    • San Francisco, California, United States, 94158
      • Regents of the University of California
    • Whittier, California, United States, 90603
      • The Oncology Institute of Hope & Innovation
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado at Denver and Health Sciences Center
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • Weeki Wachee, Florida, United States, 34607
      • ASCLEPES Research Centers
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Columbus, Georgia, United States, 31904
      • IACT Health, John B. Amos Cancer Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Ashland-Bellefonte Cancer Center
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114-2696
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-9001
      • University South Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48302
      • Karmanos Cancer Institute
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri - Ellis Fischel Cancer Center
    • Kansas City, Missouri, United States, 64114
      • Midamerica Cancer Care
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 89148
      • Comprehensive Cancer Center of Nevada (Southern Hills) (USA)
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital-Long Island Oncology
    • New York, New York, United States, 10016
      • NYU Grossman School of Medicine
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospital Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center- Stephenson Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina- Hollings Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • IHO Corporation/Utah Cancer Specialists
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
• Histologically confirmed diagnosis of previously untreated Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb according to the American Joint Committee on Cancer(AJCC))/Classification of malignant tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant metastasis (TNM) Staging System, 8th Edition.) suitable for definitive ChemoRadiotherapy (CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx
• For OroPharyngeal Cancer (OPC) participants, primary tumors must be human papillomavirus (HPV)-negative as determined by p16 expression using immunohistochemistry
• Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on Response evaluation criteria in solid tumors (RECIST) version 1.1
• Peripheral neuropathy less than (<) grade 2
• Adequate hematologic, renal and hepatic function
• Other protocol defined inclusion criteria may apply

Exclusion Criteria:

• Primary tumor of nasopharynx, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site
• Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.)
• Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents
• Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0 g/dL. No albumin transfusions are allowed within 2 weeks before randomization
• Known allergy to Xevinapant (Debio 1143), cisplatin, carboplatin, other platinum-based agent or any excipient known to be present in any of these products or in the placebo formulation
• other protocol defined exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xevinapant (Debio 1143); Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy; Cisplatin; Xevinapant (Debio 1143) Monotherapy period (Cycles 4-6): • Xevinapant (Debio 1143)	Drug: Xevinapant (Debio 1143); Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.; Drug: Cisplatin; Cisplatin administered as an IV infusion every 3 weeks (Q3W).; Radiation: Intensity Modulation Radiation Therapy (IMRT); 70 Gy given in 35 fractions over 7 weeks.
Active Comparator: Placebo; Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy; Cisplatin; Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo	Drug: Cisplatin; Cisplatin administered as an IV infusion every 3 weeks (Q3W).; Radiation: Intensity Modulation Radiation Therapy (IMRT); 70 Gy given in 35 fractions over 7 weeks.; Drug: Placebo; Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-Free Survival (EFS)	EFS is the time from the date of randomization to the date of first record of disease progression or death.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is the time from randomization to death due to any cause.	Up to 5 years
Progression-Free Survival (PFS)	PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)	Up to 5 years
Locoregional Control (LRC)		From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years)
Objective Response Rate (ORR)	ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).	Up to 5 years
Complete Response Rate (CRR)	CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).	Up to 5 years
Duration of Response (DOR)	Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.	Up to 5 years
Number of Participants with Radical Salvage Surgery		Up to 5 years
Time to Subsequent Systemic Cancer Treatments		Up to 5 years
Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure		From signed informed consent to EOS (within 6.8 years)
Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom	Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)	Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
Changes from Baseline in Swallowing and Pain Symptoms	Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)	Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)

Collaborators and Investigators

• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA, Darmstadt, Germany; GORTEC (Head and Neck Oncology and Radiotherapy Group)
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

General Publications

• Bourhis J, Burtness B, Licitra LF, Nutting C, Schoenfeld JD, Omar M, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen EE. Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design. Future Oncol. 2022 May;18(14):1669-1678. doi: 10.2217/fon-2021-1634. Epub 2022 Feb 17.

Helpful Links

• Trial Awareness and Transparency website

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: TrilynX
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: MS202359_0006; 2020-000377-25 (EudraCT Number); Debio 1143-SCCHN-301 (Other Identifier: Previous Sponsor Identifier)

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: 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 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
• product manufactured in and exported from the U.S.: No