Clinical trial NCT04459715: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: TrilynX
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: GORTEC (Head and Neck Oncology and Radiotherapy Group)
name: Merck KGaA, Darmstadt, Germany
First posted: 2020-07-07
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years
measure: Locoregional Control (LRC)
timeFrame: 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)
measure: Objective Response Rate (ORR)
timeFrame: Up to 5 years
measure: Complete Response Rate (CRR)
timeFrame: Up to 5 years
measure: Duration of Response (DOR)
timeFrame: Up to 5 years
measure: Number of Participants with Radical Salvage Surgery
timeFrame: Up to 5 years
measure: Time to Subsequent Systemic Cancer Treatments
timeFrame: Up to 5 years
measure: 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
timeFrame: From signed informed consent to EOS (within 6.8 years)
measure: Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
timeFrame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
measure: Changes from Baseline in Swallowing and Pain Symptoms
timeFrame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: San Francisco
country: United States
facility: Regents of the University of California
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Aurora
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Weeki Wachee
country: United States
facility: ASCLEPES Research Centers
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Columbus
country: United States
facility: IACT Health, John B. Amos Cancer Center
state: Georgia
city: Fort Wayne
country: United States
facility: Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Ashland
country: United States
facility: Ashland-Bellefonte Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University South Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer institute
state: Michigan
city: Columbia
country: United States
facility: University of Missouri - Ellis Fischel Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: MidAmerica Cancer Care
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Center of Nevada (Southern Hills) (USA)
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Mineola
country: United States
facility: NYU Langone Hospital-Long Island Oncology
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center- Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina- Hollings Cancer Center
state: South Carolina
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Salt Lake City
country: United States
facility: IHO Corporation/Utah Cancer Specialists
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especialazado Alexander Fleming
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: Santa Fe
country: Argentina
facility: Instituto de Oncologia de Rosario
city: Viedma
country: Argentina
facility: Clinica Viedma
city: Adelaide
country: Australia
facility: Ashford Cancer Centre Research, Tennyson Centre
city: Darlinghurst
country: Australia
facility: St Vincents Hospital
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital, Cancer Trials Unit
city: Graz
country: Austria
facility: Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin III der PMU
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Medicine I, Division of Oncology
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent UZ Gent
city: La Louvière
country: Belgium
facility: Hopital de Jolimont, Rue Ferrer
city: Leuven
country: Belgium
facility: UZ Leuven, Radiotherapy & Oncology
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne (CHA)
city: Namur
country: Belgium
facility: CHU UCL Namur Site Sainte Elisabeth
city: Sint-Niklaas
country: Belgium
facility: A.Z. Nikolaas
city: Wilrijk
country: Belgium
facility: GZA Sint-Augustinus
city: Barretos
country: Brazil
facility: Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijui, Avenida David Jose Martins
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
city: Porto Alegre
country: Brazil
facility: Centro Gaúcho Integrado, Rua Costa
city: Porto Alegre
country: Brazil
facility: Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
city: Porto Alegre
country: Brazil
facility: Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
city: Rio De Janeiro
country: Brazil
facility: National Cancer Institute
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo (ICESP)
city: São Paulo
country: Brazil
facility: Oswaldo Cruz German Hospital
city: London
country: Canada
facility: London Regional Cancer Program, London Health Sciences Centre
city: Montreal
country: Canada
facility: CHU Montréal
city: Montreal
country: Canada
facility: CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
city: Québec
country: Canada
facility: CHU de Quebec-Université Laval
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangdong
country: China
facility: The 5th Affiliated Hospital of Sun yet-sen university
city: Hangzhou
country: China
facility: The 2nd Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Province Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
city: Shandong
country: China
facility: Lin Yi Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
city: Shantou
country: China
facility: Shantou University Cancer Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & institute
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan
country: China
facility: Tongji Hospital/Tongji Medical College, Huazhong University of Science
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Hradec Králové
country: Czechia
facility: University Hospital hradec Kralové
city: Ostrava-Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Prague
country: Czechia
facility: Hospital Na Bulovce
city: Zlín
country: Czechia
facility: KOC KNTB a.s. Zlín
city: Amiens
country: France
facility: CHU Amiens Picardie - Hopital Sud
city: Angers
country: France
facility: Institut de Cancérologie de l Ouest (ICO)
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Centre hospitalier Universitaire de Bordeaux
city: Brest
country: France
facility: CHRU de Brest Hopital Morvan
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin CLCC
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble
city: le Havre
country: France
facility: Centre Guillaume Le Conquerant
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Libourne
country: France
facility: Centre hospitalier Libourne
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: Hôpital du Scorff
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Service d'Oncologie Médicale, CHU Timone
city: Montbeliard
country: France
facility: Hôpital Nord Franche Comté
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier
city: Nantes Cedex 2
country: France
facility: LHopital prive du Confluent Nantes
city: Neuilly sur Seine
country: France
facility: CCConcorde (GCS)
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Institut Curie
city: Rennes Cedex
country: France
facility: Centre Eugène Marquis
city: Rouen Cedex
country: France
facility: Centre Henri Becquerel CLCC
city: Saint Gregoire
country: France
facility: CHP Saint Gregoire FINESS
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - Site Saint Herblain
city: Strasbourg
country: France
facility: ICANS
city: Toulouse
country: France
facility: Institut Claudius Regaud - IUCT-O
city: Tours
country: France
facility: CHU de Tours
city: Vandoeuvre les Nancy
country: France
facility: The Public Hospital L'Institut de Cancerologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy - Service de radiotherapie
city: Kutaisi
country: Georgia
facility: Evex Hospitals Oncology Center
city: Tbilisi
country: Georgia
facility: Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
city: Tbilisi
country: Georgia
facility: Cancer Research Cent 4
city: Tbilisi
country: Georgia
facility: Institute of Clinical Oncology
city: Tbilisi
country: Georgia
facility: JSC "Evex Hospitals"
city: Tbilisi
country: Georgia
facility: LEPL First University Clinic of Tbilisi State Medical University
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: Simon Khechinashvili University Clinic
city: Berlin
country: Germany
facility: CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Campus Virchow
city: Erlangen
country: Germany
facility: Strahlenklinik des Uni-Klinikums
city: Essen
country: Germany
facility: Department of radiation oncology, University Hospital Essen
city: Essen
country: Germany
facility: Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Jena
country: Germany
facility: Universitaetsklinikum Jena - Klinik fuer Hals - Nasen und Ohrenheilkunde HNO
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Athens
country: Greece
facility: Agioi Anargiroi General Oncology Hospital of Kifissia
city: Athens
country: Greece
facility: Attikon University Hospital
city: Thessaloníki
country: Greece
facility: Theagenio Anticancer Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet Sugarterapias Osztaly
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz Onkologiai Osztaly
city: Győr
country: Hungary
facility: Petz Aladár Megyei Kórház Onkoradiológiai Osztály
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
city: Jerusalem
country: Israel
facility: Research Fund of the Hadassah Medical Organization
city: Petach Tiqva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS
city: Cuneo
country: Italy
facility: Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Genova
country: Italy
facility: IRCCS AOU San Martino
city: Lecce
country: Italy
facility: Ospedale "Vito Fazzi" Lecce
city: Livorno
country: Italy
facility: Az. USL 6 Ospedali Riuniti-Ospedale di Livorno
city: Meldola
country: Italy
facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
city: Milan
country: Italy
facility: IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO
city: Milan
country: Italy
facility: Istituto Nazionale dei Tumori
city: Modena
country: Italy
facility: Policlinico di Modena
city: Napoli
country: Italy
facility: AORN Ospedale dei Monaldi
city: Napoli
country: Italy
facility: AOU "Luigi Vanvitelli"
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale"
city: Padova
country: Italy
facility: Istituto Oncologico Veneto Irccs
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Savona
country: Italy
facility: ASL2_Presidio Ospedaliero San Paolo
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Chuo-ku Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Kamigyo-ku
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kita-Ku
country: Japan
facility: Hokkaido University Hospital
city: Kita-ku
country: Japan
facility: Okayama University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Nagaizumi-cho
country: Japan
facility: Shizuoka Cancer Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center Hematologic Oncology
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Asian Cacer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: KonKuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital, Oncol & Hematology
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Gliwice
country: Poland
facility: Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
city: Olsztyn
country: Poland
facility: SP ZOZ MSWiA z W-M CO w Olsztynie
city: Łódź
country: Poland
facility: NZOZ Provita Prolife Centrum Medyczne
city: Braga
country: Portugal
facility: Centro Clinico Academico
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
city: Faro
country: Portugal
facility: Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)
city: Lissabon
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte
city: Porto
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario São João
city: Porto
country: Portugal
facility: Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E
city: Kazan
country: Russian Federation
facility: State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: FGBU N.N.Blokhin Russian Cancer Research Center
city: Saint Petersburg
country: Russian Federation
facility: EuroCityClinic
city: Saint Petersburg
country: Russian Federation
facility: Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
city: Saint-Petersburg
country: Russian Federation
facility: FSBI National Med Research Cancer Center N.N. Petrov
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncological Dispensary of Bashkortostan
city: Ufa
country: Russian Federation
facility: State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital
city: A Coruña
country: Spain
facility: Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro"
state: Galicia
city: A Coruna
country: Spain
facility: Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Català d'Oncologia Badalona
city: Barcelona
country: Spain
facility: Institut Català d'Oncologia, Hospital Duran
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus-Quiron (ESP)
city: Cordoba
country: Spain
facility: Hospital Reina Sofía
city: Girona
country: Spain
facility: Institut Català d'Oncologia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Manresa
country: Spain
facility: Althaia, Xarxa Assistencial
city: Manresa
country: Spain
facility: Fundacio Althaia
city: Málaga
country: Spain
facility: Hospital Civil (Hospital Regional Universitario)
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla. Santander
city: Valencia
country: Spain
facility: Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valencia
country: Spain
facility: IVO
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois Lausanne
city: Kaohsiung City
country: Taiwan
facility: Chang-Gung Memorial Hospital-Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Memorial Hospital
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital (VGHTP)
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital
city: Khodosivka
country: Ukraine
facility: Medical center ASKLEPION LLC
city: Kiev
country: Ukraine
facility: Kiev City Clinical Oncology Centre
city: Kyiv
country: Ukraine
facility: Medical center of Yuriy Spizhenko, Soborna Vulytsia
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal infirmary, Dept. of Oncology
city: Chelsea
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Sutton
city: Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre NHS Foundation Trust
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.