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)

September 19, 2025 updated by: EMD Serono Research & Development Institute, Inc.

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 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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

730

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Alemán
      • Buenos Aires, Argentina
        • Instituto Medico Especialazado Alexander Fleming
      • Córdoba, Argentina
        • Clínica Universitaria Reina Fabiola
      • Santa Fe, Argentina
        • Instituto de Oncología de Rosario
      • Viedma, Argentina
        • Clínica 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
      • Brussels, Belgium
        • Cliniques universitaires Saint-Luc
      • Charleroi, Belgium
        • Grand Hôpital de Charleroi
      • Edegem, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Ghent, 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 Sao 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 Králové
      • 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, 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, France
        • CHU de Grenoble
      • Le Havre, France
        • Centre Guillaume Le Conquerant
      • 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
      • Montbéliard, France
        • Hopital Nord Franche Comte
      • Montpellier, France
        • Institut régional du Cancer de Montpellier
      • Nantes, France
        • LHopital prive du Confluent Nantes
      • Neuilly-sur-Seine, France
        • CCConcorde (GCS)
      • Nice, France
        • Centre Antoine Lacassagne
      • Nîmes, France
        • CHU Nimes
      • Paris, France
        • Institut Curie
      • Rennes, France
        • Centre Eugène Marquis
      • Rouen, France
        • Centre Henri Becquerel CLCC
      • Saint-Grégoire, 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
      • Vandœuvre-lès-Nancy, France
        • The Public Hospital L'Institut de Cancerologie de Lorraine
      • Villejuif, France
        • Institut Gustave Roussy - Service de radiotherapie
  • 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
      • Tbilisi, Georgia
        • Simon Khechinashvili University Clinic
  • 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
      • Jena, Germany
        • Universitaetsklinikum Jena - Klinik fuer Hals - Nasen und Ohrenheilkunde HNO
      • 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
      • Thessaloniki, 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
      • Florence, 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"
      • Padua, 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
      • Hyōgo, Japan
        • Hyogo Cancer Center
      • Kamigyō-ku, Japan
        • University Hospital Kyoto Prefectural University of Medicine
      • Kanagawa, Japan
        • Tokai University Hospital
      • Kita-ku, Japan
        • Okayama University Hospital
      • Kita-ku, Japan
        • Hokkaido University Hospital
      • Kobe, Japan
        • Kobe University Hospital
      • Kōtoku, 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
  • Poland
      • Gdansk, 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
      • Lodz, Poland
        • Nzoz Provita Prolife Centrum Medyczne
      • Olsztyn, Poland
        • SP ZOZ MSWiA z W-M CO w Olsztynie
  • 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)
      • Lisbon, Portugal
        • Centro Hospitalar Universitario Lisboa Norte
      • Porto, Portugal
        • Hospital Pedro Hispano
      • Porto, Portugal
        • Centro Hospitalar Universitário São João
      • Porto, Portugal
        • Centro Hospitalar de Vila Nova de Gaia/Espinho
      • Porto, Portugal
        • Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E
  • Russia
      • Kazan', Russia
        • State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"
      • Krasnoyarsk, Russia
        • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky
      • Kursk, Russia
        • Kursk Regional Clinical Oncology Dispensary
      • Moscow, Russia
        • FGBU N.N.Blokhin Russian Cancer Research Center
      • Saint Petersburg, 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)
      • Ufa, Russia
        • Republican Clinical Oncological Dispensary of Bashkortostan
      • Ufa, Russia
        • State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)
      • Yaroslavl, Russia
        • State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital
  • South Korea
      • Busan, South Korea
        • Pusan National University Hospital
      • Goyang-si, South Korea
        • National Cancer Center
      • Goyang-si, South Korea
        • National Cancer Center Hematologic Oncology
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Konkuk University Medical Center
      • Seoul, South Korea
        • Asan Medical Center, Asian Cacer Center
      • Seoul, South Korea
        • Seoul National University Boramae Medical Center
      • Yangsan, South Korea
        • Pusan National University Yangsan Hospital, Oncol & Hematology
  • Spain
      • A Coruña, 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 Clínic Barcelona
      • Barcelona, Spain
        • Institut Català d'Oncologia Badalona
      • Barcelona, Spain
        • Institut Català d'Oncologia, Hospital Duran
      • Barcelona, Spain
        • Institut Universitari Dexeus-Quiron (ESP)
      • Córdoba, Spain
        • Hospital Reina Sofia
      • Girona, Spain
        • Institut Catala D'oncologia
      • Las Palmas de Gran Canaria, Spain
        • Hospital Universitario Insular de Gran Canaria
      • Madrid, Spain
        • Hospital Ramon 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
        • Fundació Althaïa
      • 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
      • Geneva, Switzerland
        • Hopitaux Universitaires de Geneve
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois Lausanne
  • Taiwan
      • Kaohsiung City, Taiwan
        • Chang-Gung Memorial Hospital-Kaohsiung
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital (VGHTP)
      • Taoyuan, Taiwan
        • Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital
  • Ukraine
      • Khodosovka, 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
      • Metropolitan Borough of Wirral, United Kingdom
        • Clatterbridge Cancer Centre 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
  • 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 D.C., 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
      • St 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xevinapant (Debio 1143)

Participants received:

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 received:

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) as Assessed by Blinded Independent Review Committee (BIRC)
Time Frame: From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization to the earliest between death or EOS (up to 188 weeks and 5 days)
Overall survival is defined as the time from randomization to the date of death. Calculated via Kaplan Meier method.
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)
Time Frame: 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 )
PFS according to RECIST v1.1 defined as the time from randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 millimeter (mm) in the SOD, or the appearance of new lesions. Calculated via Kaplan Meier method.
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
Time Frame: 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)
LRC time is defined as the time from randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes, either according to RECIST v1.1 or based on clinical assessment (radiological or clinical, as assessed by the Investigator). According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 millimeter (mm) in the SOD, or the appearance of new lesions. Calculated via Kaplan Meier method.
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
Time Frame: At 9 and 12 months post randomization
Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, or unequivocal progression of non-target lesions, or appearance of any new lesion.
At 9 and 12 months post randomization
Complete Response Rate (CRR)
Time Frame: At 9 and 12 months post randomization
CRR defined as the number of participants with Complete Response by RECIST v1.1, as assessed by the BIRC. Complete response is defined as disappearance of all target and non-target lesions.
At 9 and 12 months post randomization
Duration of Response (DOR)
Time Frame: Time from first evidence of response to the first occurrence of progression or death from any cause, assessed up to 24 months
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. Kaplan Meier method was used for calculation.
Time from first evidence of response to the first occurrence of progression or death from any cause, assessed up to 24 months
Number of Participants With Radical Salvage Surgery
Time Frame: At 9, 12, 24 and 36 months post randomization
Number of Participants with Radical Salvage Surgery (excluding elective neck dissection without anatomopathological evidence of residual malignant cells) was reported.
At 9, 12, 24 and 36 months post randomization
Time to Subsequent Systemic Cancer Treatments
Time Frame: Up to 188 weeks and 5 days post randomization
Time to new subsequent systemic cancer treatment (in months) was derived as (date of event/censoring - randomization date +1) / 30.4375. Calculated via kaplan meier method.
Up to 188 weeks and 5 days post randomization
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest
Time Frame: From signed informed consent to EOS (up to 188 weeks and 5 days)
An AE is any unfavorable/unintended sign (e.g., abnormal lab result), symptom or disease temporally linked to study drug, whether or not related. A serious AE leads to death, is life-threatening, causes significant/persistent disability, hospitalization, congenital anomaly, or is medically important. TEAEs include both serious and non-serious AEs after treatment. AESIs are events of clinical interest needing close monitoring. In this study, AESIs include: infusion reactions including hypersensitivity, immune-related AEs, aspartate aminotransferase/alanine transaminase increases, lipase/amylase elevation, acute renal failure, QTcF more than 30 milliseconds above baseline, and ≥Grade 2 inflammatory cutaneous AEs.
From signed informed consent to EOS (up to 188 weeks and 5 days)
Number of Participants With Severity of Grade Greater or Equal to 3 TEAEs
Time Frame: From signed informed consent to EOS (up to 188 weeks and 5 days)
Severity of TEAEs were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE.
From signed informed consent to EOS (up to 188 weeks and 5 days)
Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes
Time Frame: At Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes was reported.
At Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Laboratory Parameters: Erythrocytes
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: Erythrocytes was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Laboratory Parameters: C Reactive Protein
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: C Reactive Protein was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Estimated Glomerular Filtration Rate
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from baseline in biochemistry parameter eGFR was reported. The Glomerular Filtration Rate was measured as milliliter per minute per 1.73 square meter (mL/min/1.73m^2).
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in coagulation parameter activated PTT/standard and prothrombin Time was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Fibrinogen
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from Baseline in coagulation parameter fibrinogen was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Prothrombin International Normalized Ratio
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change from baseline in coagulation parameters prothrombin international normalized ratio was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change)
Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change from Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change From Baseline in Vital Signs: Heart Rate
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change from Baseline in Vital Signs: Heart Rate was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change From Baseline in Vital Signs: Respiratory Rate
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change from Baseline in Vital Signs: Respiratory Rate was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change From Baseline in Vital Signs: Body Temperature
Time Frame: At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase)
Change from Baseline in Vital Signs: Body Temperature was reported.
At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase)
Change From Baseline in Vital Signs: Body Weight
Time Frame: At Baseline, C3D1 (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change from Baseline in Vital Signs: Body Weight was reported.
At Baseline, C3D1 (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase & decrease)
Change From Baseline in ECG Parameters
Time Frame: At Baseline, and upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase)
The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included Respiratory Rate (RR), Pulse Rate (PR), QRS, QT and QTcF calculated by the Bazett formula.
At Baseline, and upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase)
Treatment Duration
Time Frame: Up to end of study (up to 188weeks and 5 days)
Treatment duration is calculated by study treatment component as (last dose date minus first dose date plus x)/7, where x=8 for xevinapant/matched placebo, x=21 for cisplatin/carboplatin, x=3 for IMRT.
Up to end of study (up to 188weeks and 5 days)
Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6
Time Frame: Cycle 1, 2, 3, 4, 5 and 6 (each cycle is of 3 weeks)
Number of participants who completed cycle 1, 2, 3, 4, 5 or 6 of xevinapant/matched placebo were reported.
Cycle 1, 2, 3, 4, 5 and 6 (each cycle is of 3 weeks)
Total Cumulative Dose of Xevinapant/ Matched Placebo
Time Frame: Up to end of treatment (Day 134)
Total cumulative dose of Xevinapant/ Matched Placebo was reported in form of mean and standard deviation.
Up to end of treatment (Day 134)
Total Cumulative Dose of Cisplatin
Time Frame: Up to end of treatment (Day 134)
Total cumulative dose of cisplatin was reported.
Up to end of treatment (Day 134)
Total Cumulative Dose of Carboplatin
Time Frame: Up to end of treatment (Day 134)
Total cumulative dose of carboplatin was reported as mean and standard deviation.
Up to end of treatment (Day 134)
Total Cumulative Dose of Intensity-Modulated Radiation Therapy (IMRT)
Time Frame: Up to end of treatment (Day 134)
Total cumulative dose of IMRT were reported in form of mean and standard deviation.
Up to end of treatment (Day 134)
Overall Dose Intensity of Xevinapant/Matched Placebo
Time Frame: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)
Overall dose intensity of Xevinapant/ matched placebo is calculated as the mean of the dose intensities of the individual cycles.
Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)
Overall Dose Intensity of Cisplatin
Time Frame: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)
Overall dose intensity of Cisplatin is calculated as the mean of the dose intensities of the individual cycles. This was reported with the unit of measure milligrams per meter square per week (mg/m2/week).
Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)
Overall Dose Intensity of Carboplatin
Time Frame: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)
Overall dose intensity of Carboplatin is calculated as the mean of the dose intensities of the individual cycles. This was reported with unit of measure Milligrams per minute per milliliter per week (mg min/mL/week).
Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)
Relative Dose Intensity
Time Frame: Up to 50 months
Relative dose intensity (RDI) represents the percentage of the amount of a drug actually delivered [actual dose intensity (DI)] to the amount planned (planned DI). The purpose of calculating RDI is to evaluate whether the planned DI of an anti-cancer treatment was actually achieved which may suggest the feasibility of planned treatment regimen.
Up to 50 months
Number of Participants With Treatment Interruption, Treatment Reduction and Treatment Discontinuation for Xevinapant/ Matched Placebo
Time Frame: Up to end of treatment (Day 134)
Number of participants with Treatment Interruption, Treatment Reduction and Treatment Discontinuation was reported.
Up to end of treatment (Day 134)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2020

Primary Completion (Actual)

September 18, 2024

Study Completion (Actual)

September 18, 2024

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 (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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