Study Stopped
Study has crossed the pre-defined futility boundary at the Interim Analysis.
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)
3 other identifiers
interventional
730
25 countries
284
Brief Summary
The primary objective of the study was 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Typical duration for phase_3
284 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2024
CompletedResults Posted
Study results publicly available
October 8, 2025
CompletedOctober 8, 2025
September 1, 2025
4.1 years
June 30, 2020
August 8, 2025
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-Free Survival (EFS) as Assessed by Blinded Independent Review Committee (BIRC)
Event-Free Survival (EFS) as assessed by BIRC is the time from randomization to the first of: (1) Death from any cause; (2) Progression: either radiological (per RECIST v1.1) or clinical (with/without radiologic proof, assessed endoscopically); (3) Primary treatment failure prior to complete response (CR): requirement for radical salvage surgery at primary tumor site with viable tumor confirmed histologically, even without RECIST progression; (4) Relapse after CR (locoregional): including radical salvage surgery or elective neck dissection/biopsy more than equal to (\>=) 22 weeks post-randomization showing viable tumor cells regardless of radiologic status; (5) Second cancers, unless histology excludes squamous origin. Calculated via Kaplan Meier method.
From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days)
Secondary Outcomes (39)
Overall Survival (OS)
From randomization to the earliest between death or EOS (up to 188 weeks and 5 days)
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC)
From randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause or EOS (up to 188 weeks and 5 days )
Locoregional Control (LRC) Time
From randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End Of Study (EOS) (188 weeks and 5 days)
Objective Response Rate (ORR) as Assessed by BIRC
At 9 and 12 months post randomization
Complete Response Rate (CRR)
At 9 and 12 months post randomization
- +34 more secondary outcomes
Study Arms (2)
Xevinapant (Debio 1143)
EXPERIMENTALParticipants received: Concomitant chemo-radiation therapy period (Cycles 1-3): * Radiotherapy * Cisplatin * Xevinapant (Debio 1143) Monotherapy period (Cycles 4-6): • Xevinapant (Debio 1143)
Placebo
ACTIVE COMPARATORParticipants received: Concomitant chemo-radiation therapy period (Cycles 1-3): * Radiotherapy * Cisplatin * Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo
Interventions
Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.
Cisplatin administered as an IV infusion every 3 weeks (Q3W).
70 Gy given in 35 fractions over 7 weeks.
Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (288)
The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)
Birmingham, Alabama, 35233, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Regents of the University of California
San Francisco, California, 94158, United States
UCSF
San Francisco, California, 94158, United States
The Oncology Institute of Hope & Innovation
Whittier, California, 90603, United States
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045, United States
Yale Cancer Center
New Haven, Connecticut, 06519, United States
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
ASCLEPES Research Centers
Weeki Wachee, Florida, 34607, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
IACT Health, John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, 41101, United States
Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus
Louisville, Kentucky, 40241, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696, United States
Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University South Hospital
Ann Arbor, Michigan, 48109-9001, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Karmanos Cancer institute
Detroit, Michigan, 48302, United States
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
MidAmerica Cancer Care
Kansas City, Missouri, 64114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Comprehensive Cancer Center of Nevada (Southern Hills) (USA)
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
NYU Langone Hospital-Long Island Oncology
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
NYU Grossman School of Medicine
New York, New York, 10016, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center- Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Medical University of South Carolina- Hollings Cancer Center
Charleston, South Carolina, 29425, United States
MD Anderson
Houston, Texas, 77030, United States
IHO Corporation/Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Hospital Aleman
Buenos Aires, Argentina
Instituto Medico Especialazado Alexander Fleming
Buenos Aires, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, 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
Brussels, Belgium
Grand Hopital de Charleroi
Charleroi, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent UZ Gent
Ghent, 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, 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, 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
Montbéliard, France
Institut Regional du Cancer de Montpellier
Montpellier, France
LHopital prive du Confluent Nantes
Nantes, France
CCConcorde (GCS)
Neuilly-sur-Seine, France
Centre Antoine Lacassagne
Nice, France
CHU Nimes
Nîmes, France
Institut Curie
Paris, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel CLCC
Rouen, France
CHP Saint Gregoire FINESS
Saint-Grégoire, 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
Vandœuvre-lès-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
Simon Khechinashvili University Clinic
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
Universitaetsklinikum Jena - Klinik fuer Hals - Nasen und Ohrenheilkunde HNO
Jena, 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
Thessaloniki, 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
Florence, 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
Padua, 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
Hyōgo, Japan
University Hospital Kyoto Prefectural University of Medicine
Kamigyō-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
Kōtoku, 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
Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii
Gdansk, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, Poland
Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
Gliwice, Poland
NZOZ Provita Prolife Centrum Medyczne
Lodz, Poland
SP ZOZ MSWiA z W-M CO w Olsztynie
Olsztyn, 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
Lisbon, 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', Russia
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky
Krasnoyarsk, Russia
Kursk Regional Clinical Oncology Dispensary
Kursk, Russia
FGBU N.N.Blokhin Russian Cancer Research Center
Moscow, Russia
EuroCityClinic
Saint Petersburg, Russia
FSBI National Med Research Cancer Center N.N. Petrov
Saint Petersburg, Russia
Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
Saint Petersburg, Russia
Republican Clinical Oncological Dispensary of Bashkortostan
Ufa, Russia
State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)
Ufa, Russia
State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital
Yaroslavl, Russia
Pusan National University Hospital
Busan, South Korea
National Cancer Center Hematologic Oncology
Goyang-si, South Korea
National Cancer Center
Goyang-si, South Korea
Asan Medical Center, Asian Cacer Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
KonKuk University Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Pusan National University Yangsan Hospital, Oncol & Hematology
Yangsan, South Korea
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 Coruña, 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
Córdoba, 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
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Switzerland
Chang-Gung Memorial Hospital-Kaohsiung
Kaohsiung City, Taiwan
Kaohsiung Medical University Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General 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, Taiwan
Medical center ASKLEPION LLC
Khodosovka, 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
Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, 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
Related Publications (2)
Bourhis J, Licitra LF, Burtness B, Psyrri A, Haddad R, Harrington K, Cohen EEW, Tao Y, Tiscoski KA, Matitashvili A, Tahara M, Sukari A, Rutkowski T, Salas S, Nauwelaerts H, Scheerlinck R, Ha NT, Schroeder A, Rodriguez-Gutierrez A, Schoenfeld JD. Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study. J Clin Oncol. 2025 Oct 10;43(29):3209-3220. doi: 10.1200/JCO-25-00272. Epub 2025 Sep 3.
PMID: 40902136DERIVEDBourhis 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.
PMID: 35172587DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 7, 2020
Study Start
August 7, 2020
Primary Completion
September 18, 2024
Study Completion
September 18, 2024
Last Updated
October 8, 2025
Results First Posted
October 8, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- 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
- 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
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