AzTrials
AzTrials

Squamous Cell Carcinoma of the Head and NeckPhase 3NCT04459715

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 Phase 3 study testing Xevinapant (Debio 1143), Cisplatin and Intensity Modulation Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of the Head and Neck, run by EMD Serono Research & Development Institute, Inc. at 288 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Xevinapant (Debio 1143), Cisplatin and Intensity Modulation Radiation Therapy (IMRT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
730 participants
Where
288 sitesin 26 countries
Study dates
7 Aug 2020to 18 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

288 sites in 26 countries.

288 sites in 26 countries

United States44 sites

  • University South Hospital

    Ann Arbor, Michigan, 48109-9001

  • Ashland-Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • University of Colorado at Denver and Health Sciences Center

    Aurora, Colorado, 80045

  • The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2696

  • Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Medical University of South Carolina- Hollings Cancer Center

    Charleston, South Carolina, 29425

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Missouri - Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • IACT Health, John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Karmanos Cancer institute

    Detroit, Michigan, 48302

  • Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • MD Anderson

    Houston, Texas, 77030

  • MidAmerica Cancer Care

    Kansas City, Missouri, 64114

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Center of Nevada (Southern Hills) (USA)

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

  • NYU Langone Hospital-Long Island Oncology

    Mineola, New York, 11501

  • Yale Cancer Center

    New Haven, Connecticut, 06519

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • NYU Grossman School of Medicine

    New York, New York, 10016

  • University of Oklahoma Health Sciences Center- Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • IHO Corporation/Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Regents of the University of California

    San Francisco, California, 94158

  • UCSF

    San Francisco, California, 94158

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • ASCLEPES Research Centers

    Weeki Wachee, Florida, 34607

  • The Oncology Institute of Hope & Innovation

    Whittier, California, 90603

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

France30 sites

  • CHU Amiens Picardie - Hopital Sud

    Amiens

  • Institut de Cancérologie de l Ouest (ICO)

    Angers

  • Institut Sainte Catherine

    Avignon

  • Centre hospitalier Universitaire de Bordeaux

    Bordeaux

  • CHRU de Brest Hopital Morvan

    Brest

  • Centre Jean Perrin CLCC

    Clermont-Ferrand

  • CHU de Grenoble

    Grenoble

  • Centre Guillaume Le Conquerant

    Le Havre

  • Clinique Victor Hugo

    Le Mans

  • Centre hospitalier Libourne

    Libourne

  • Centre Oscar Lambret

    Lille

  • Hôpital du Scorff

    Lorient

  • Centre Leon Berard

    Lyon

  • Service d'Oncologie Médicale, CHU Timone

    Marseille

  • Hôpital Nord Franche Comté

    Montbéliard

  • Institut Regional du Cancer de Montpellier

    Montpellier

  • LHopital prive du Confluent Nantes

    Nantes

  • CCConcorde (GCS)

    Neuilly-sur-Seine

  • Centre Antoine Lacassagne

    Nice

  • CHU Nimes

    Nîmes

  • Institut Curie

    Paris

  • Centre Eugène Marquis

    Rennes

  • Centre Henri Becquerel CLCC

    Rouen

  • CHP Saint Gregoire FINESS

    Saint-Grégoire

  • Institut de Cancérologie de l'Ouest - Site Saint Herblain

    Saint-Herblain

  • ICANS

    Strasbourg

  • Institut Claudius Regaud - IUCT-O

    Toulouse

  • CHU de Tours

    Tours

  • The Public Hospital L'Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy

  • Institut Gustave Roussy - Service de radiotherapie

    Villejuif

Other trials in France

Spain25 sites

  • Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro"

    A Coruña, Galicia

  • Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro

    A Coruña

  • Hospital Clinic Barcelona

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Institut Català d'Oncologia Badalona

    Barcelona

  • Institut Català d'Oncologia, Hospital Duran

    Barcelona

  • Institut Universitari Dexeus-Quiron (ESP)

    Barcelona

  • Hospital Reina Sofía

    Córdoba

  • Institut Català d'Oncologia

    Girona

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria

  • Clinica Universidad de Navarra

    Madrid

  • Hospital 12 de Octubre

    Madrid

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario HM Sanchinarro

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Civil (Hospital Regional Universitario)

    Málaga

  • Althaia, Xarxa Assistencial

    Manresa

  • Fundacio Althaia

    Manresa

  • Clinica Universidad de Navarra

    Pamplona

  • Hospital Universitario Marqués de Valdecilla. Santander

    Santander

  • Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)

    Valencia

  • Hospital Universitario La Fe

    Valencia

  • IVO

    Valencia

Other trials in Spain

China21 sites

  • Beijing Cancer Hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Xiangya Hospital Central South University

    Changsha

  • West China Hospital of Sichuan University

    Chengdu

  • Fujian Cancer Hospital

    Fuzhou

  • The 5th Affiliated Hospital of Sun yet-sen university

    Guangdong

  • The 2nd Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Province Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning

  • Lin Yi Cancer Hospital

    Shandong

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Shanghai Ninth People's Hospital

    Shanghai

  • Shantou University Cancer Hospital

    Shantou

  • Liaoning Cancer Hospital & institute

    Shenyang

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • Tongji Hospital/Tongji Medical College, Huazhong University of Science

    Wuhan

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

Italy19 sites

  • Centro di Riferimento Oncologico

    Aviano

  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

    Brescia

  • Istituto di Candiolo IRCCS

    Candiolo

  • Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle

    Cuneo

  • Azienda Ospedaliero-Universitaria Careggi

    Florence

  • IRCCS AOU San Martino

    Genova

  • Ospedale "Vito Fazzi" Lecce

    Lecce

  • Az. USL 6 Ospedali Riuniti-Ospedale di Livorno

    Livorno

  • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola

  • IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO

    Milan

  • Istituto Nazionale dei Tumori

    Milan

  • Policlinico di Modena

    Modena

  • AORN Ospedale dei Monaldi

    Naples

  • AOU "Luigi Vanvitelli"

    Naples

  • Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale"

    Naples

  • Istituto Oncologico Veneto Irccs

    Padova

  • Azienda Ospedaliero Universitaria di Parma

    Parma

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome

  • ASL2_Presidio Ospedaliero San Paolo

    Savona

Other trials in Italy

Japan14 sites

  • National Cancer Center Hospital East

    Chiba

  • National Cancer Center Hospital

    Chuo-ku Tokyo

  • Saitama Medical University International Medical Center

    Hidaka

  • Hyogo Cancer Center

    Hyōgo

  • University Hospital Kyoto Prefectural University of Medicine

    Kamigyō-ku

  • Tokai University Hospital

    Kanagawa

  • Hokkaido University Hospital

    Kita-ku

  • Okayama University Hospital

    Kita-ku

  • Kobe University Hospital

    Kobe

  • Cancer Institute Hospital of JFCR

    Kōtoku

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama

  • Shizuoka Cancer Center

    Nagaizumi-cho

  • Osaka International Cancer Institute

    Osaka

  • Tokyo Medical University Hospital

    Tokyo

Other trials in Japan

Germany12 sites

  • CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie

    Berlin

  • Charité - Universitätsmedizin Berlin Campus Virchow

    Berlin

  • Strahlenklinik des Uni-Klinikums

    Erlangen

  • Department of radiation oncology, University Hospital Essen

    Essen

  • Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie

    Essen

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Universitaetsklinikum Jena - Klinik fuer Hals - Nasen und Ohrenheilkunde HNO

    Jena

  • University Medical Center Schleswig-Holstein, Campus Kiel

    Kiel

  • Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie

    Leipzig

  • Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie

    Mannheim

  • Universitaetsklinikum Regensburg

    Regensburg

  • Universitaetsmedizin Rostock

    Rostock

Other trials in Germany

Brazil11 sites

  • Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela

    Barretos

  • Hospital de Caridade de Ijui, Avenida David Jose Martins

    Ijuí

  • Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro

    Natal

  • Centro Gaúcho Integrado, Rua Costa

    Porto Alegre

  • Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer

    Porto Alegre

  • Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer

    Porto Alegre

  • National Cancer Institute

    Rio de Janeiro

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC

    Santo André

  • Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima

    São José do Rio Preto

  • Instituto do Cancer do Estado de Sao Paulo (ICESP)

    São Paulo

  • Oswaldo Cruz German Hospital

    São Paulo

Other trials in Brazil

United Kingdom11 sites

  • Aberdeen Royal infirmary, Dept. of Oncology

    Aberdeen

  • Royal Marsden NHS Foundation Trust

    Chelsea

  • NHS Greater Glasgow and Clyde

    Glasgow

  • Royal Surrey County Hospital

    Guildford

  • Charing Cross Hospital

    London

  • The Christie NHS Foundation Trust

    Manchester

  • Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral

  • Mount Vernon Cancer Centre

    Northwood

  • Nottingham University Hospitals NHS Trust

    Nottingham

  • University Hospital Southampton NHS Foundation Trust

    Southampton

  • The Royal Marsden NHS Foundation Trust - Sutton

    Sutton

Other trials in United Kingdom

Belgium10 sites

  • Cliniques universitaires Saint-Luc

    Brussels

  • Grand Hopital de Charleroi

    Charleroi

  • Universitair Ziekenhuis Antwerpen

    Edegem

  • Universitair Ziekenhuis Gent UZ Gent

    Ghent

  • Hopital de Jolimont, Rue Ferrer

    La Louvière

  • UZ Leuven, Radiotherapy & Oncology

    Leuven

  • Centre Hospitalier de l'Ardenne (CHA)

    Libramont

  • CHU UCL Namur Site Sainte Elisabeth

    Namur

  • A.Z. Nikolaas

    Sint-Niklaas

  • GZA Sint-Augustinus

    Wilrijk

Other trials in Belgium

Russia10 sites

  • State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"

    Kazan'

  • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky

    Krasnoyarsk

  • Kursk Regional Clinical Oncology Dispensary

    Kursk

  • FGBU N.N.Blokhin Russian Cancer Research Center

    Moscow

  • EuroCityClinic

    Saint Petersburg

  • FSBI National Med Research Cancer Center N.N. Petrov

    Saint Petersburg

  • Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

    Saint Petersburg

  • Republican Clinical Oncological Dispensary of Bashkortostan

    Ufa

  • State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)

    Ufa

  • State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital

    Yaroslavl

Other trials in Russia

Portugal9 sites

  • Centro Clinico Academico

    Braga

  • Hospital de Braga

    Braga

  • Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE

    Coimbra

  • Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)

    Faro

  • Centro Hospitalar Universitário Lisboa Norte

    Lisbon

  • Centro Hospitalar de Vila Nova de Gaia/Espinho

    Porto

  • Centro Hospitalar Universitario São João

    Porto

  • Hospital Pedro Hispano

    Porto

  • Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E

    Porto

Other trials in Portugal

South Korea9 sites

  • Pusan National University Hospital

    Busan

  • National Cancer Center Hematologic Oncology

    Goyang-si

  • National Cancer Center

    Goyang-si

  • Asan Medical Center, Asian Cacer Center

    Seoul

  • Asan Medical Center

    Seoul

  • KonKuk University Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Seoul National University Boramae Medical Center

    Seoul

  • Pusan National University Yangsan Hospital, Oncol & Hematology

    Yangsan

Other trials in South Korea

Georgia8 sites

  • Evex Hospitals Oncology Center

    Kutaisi

  • Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine

    Tbilisi

  • Cancer Research Cent 4

    Tbilisi

  • Institute of Clinical Oncology

    Tbilisi

  • JSC "Evex Hospitals"

    Tbilisi

  • LEPL First University Clinic of Tbilisi State Medical University

    Tbilisi

  • New Hospitals

    Tbilisi

  • Simon Khechinashvili University Clinic

    Tbilisi

Other trials in Georgia

Taiwan7 sites

  • Chang-Gung Memorial Hospital-Kaohsiung

    Kaohsiung City

  • Kaohsiung Medical University Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital (VGHTP)

    Taipei

  • Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital

    Taoyuan City

Other trials in Taiwan

Australia6 sites

  • Ashford Cancer Centre Research, Tennyson Centre

    Adelaide

  • St Vincents Hospital

    Darlinghurst

  • St Vincents Hospital Melbourne

    Fitzroy

  • Peter MacCallum Cancer Centre

    Melbourne

  • Wollongong Hospital

    Wollongong

  • Princess Alexandra Hospital, Cancer Trials Unit

    Woolloongabba

Other trials in Australia

Canada6 sites

  • London Regional Cancer Program, London Health Sciences Centre

    London

  • CHU Montréal

    Montreal

  • CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont

    Montreal

  • Hopital Maisonneuve-Rosemont

    Montreal

  • CHU de Quebec-Université Laval

    Québec

  • Sunnybrook Research Institute

    Toronto

Other trials in Canada

Argentina5 sites

  • Hospital Aleman

    Buenos Aires

  • Instituto Medico Especialazado Alexander Fleming

    Buenos Aires

  • Clinica Universitaria Reina Fabiola

    Córdoba

  • Instituto de Oncologia de Rosario

    Santa Fe

  • Clinica Viedma

    Viedma

Other trials in Argentina

Hungary5 sites

  • Orszagos Onkologiai Intezet Sugarterapias Osztaly

    Budapest

  • Uzsoki Utcai Korhaz Onkologiai Osztaly

    Budapest

  • Petz Aladár Megyei Kórház Onkoradiológiai Osztály

    Győr

  • Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet

    Pécs

  • Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika

    Szeged

Other trials in Hungary

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii

    Gdansk

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia

  • Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach

    Gliwice

  • NZOZ Provita Prolife Centrum Medyczne

    Lodz

  • SP ZOZ MSWiA z W-M CO w Olsztynie

    Olsztyn

Other trials in Poland

Austria4 sites

  • Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde

    Graz

  • Landeskrankenhaus Salzburg

    Salzburg

  • Universitätsklinik für Innere Medizin III der PMU

    Salzburg

  • Medical University of Vienna, Department of Medicine I, Division of Oncology

    Vienna

Other trials in Austria

Czechia4 sites

  • University Hospital hradec Kralové

    Hradec Králové

  • Fakultni Nemocnice Ostrava

    Ostrava-Poruba

  • Hospital Na Bulovce

    Prague

  • KOC KNTB a.s. Zlín

    Zlín

Other trials in Czechia

Israel4 sites

  • Rambam Healthcare Campus

    Haifa

  • Research Fund of the Hadassah Medical Organization

    Jerusalem

  • Rabin Medical Center

    Petach Tiqva

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

Greece3 sites

  • Agioi Anargiroi General Oncology Hospital of Kifissia

    Athens

  • Attikon University Hospital

    Athens

  • Theagenio Anticancer Hospital

    Thessaloniki

Other trials in Greece

Switzerland3 sites

  • Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie

    Bern

  • Hopitaux Universitaires de Geneve

    Geneva

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne

Other trials in Switzerland

Ukraine3 sites

  • Medical center ASKLEPION LLC

    Khodosovka

  • Kiev City Clinical Oncology Centre

    Kiev

  • Medical center of Yuriy Spizhenko, Soborna Vulytsia

    Kyiv

Other trials in Ukraine

About this study

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)

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).

Being tested
Xevinapant (Debio 1143), Cisplatin, Intensity Modulation Radiation Therapy (IMRT), Placebo
Keywords
TrilynX
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xevinapant (Debio 1143)Drug

    Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.

  • CisplatinDrug

    Cisplatin administered as an IV infusion every 3 weeks (Q3W).

  • Intensity Modulation Radiation Therapy (IMRT)Radiation

    70 Gy given in 35 fractions over 7 weeks.

  • PlaceboDrug

    Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

Study groups in NCT04459715
Study groupRoleWhat they receive
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)
Receives: Drug: Xevinapant (Debio 1143); Drug: Cisplatin; Radiation: Intensity Modulation Radiation Therapy (IMRT)
PlaceboActive comparatorParticipants received: Concomitant chemo-radiation therapy period (Cycles 1-3): * Radiotherapy * Cisplatin * Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo
Receives: Drug: Cisplatin; Radiation: Intensity Modulation Radiation Therapy (IMRT); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days)

Secondary outcomes (39)

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to the date of death. Calculated via Kaplan Meier method.

    Measured: From randomization to the earliest between death or EOS (up to 188 weeks and 5 days)

  2. Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC)

    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.

    Measured: 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 )

  3. Locoregional Control (LRC) Time

    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.

    Measured: 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)

  4. Objective Response Rate (ORR) as Assessed by BIRC

    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.

    Measured: At 9 and 12 months post randomization

  5. Complete Response Rate (CRR)

    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.

    Measured: At 9 and 12 months post randomization

  6. Duration of Response (DOR)

    Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause. Kaplan Meier method was used for calculation.

    Measured: Time from first evidence of response to the first occurrence of progression or death from any cause, assessed up to 24 months

  7. Number of Participants With Radical Salvage Surgery

    Number of Participants with Radical Salvage Surgery (excluding elective neck dissection without anatomopathological evidence of residual malignant cells) was reported.

    Measured: At 9, 12, 24 and 36 months post randomization

  8. Time to Subsequent Systemic Cancer Treatments

    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.

    Measured: Up to 188 weeks and 5 days post randomization

  9. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest

    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.

    Measured: From signed informed consent to EOS (up to 188 weeks and 5 days)

  10. Number of Participants With Severity of Grade Greater or Equal to 3 TEAEs

    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.

    Measured: From signed informed consent to EOS (up to 188 weeks and 5 days)

  11. Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets

    Change from Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets was reported.

    Measured: 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)

  12. Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes

    Change from Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes was reported.

    Measured: 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)

  13. Change From Baseline in Laboratory Parameters: Erythrocytes

    Change from Baseline in Laboratory Parameters: Erythrocytes was reported.

    Measured: 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)

  14. Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein

    Change from Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein was reported.

    Measured: 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)

  15. Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase

    Change from Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase was reported.

    Measured: 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)

  16. Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate

    Change from Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate was reported.

    Measured: 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)

  17. Change From Baseline in Laboratory Parameters: C Reactive Protein

    Change from Baseline in Laboratory Parameters: C Reactive Protein was reported.

    Measured: 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)

  18. Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea

    Change from Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea was reported.

    Measured: 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)

  19. Change From Baseline in Estimated Glomerular Filtration Rate

    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).

    Measured: 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)

  20. Change From Baseline in Activated Partial Thromboplastin Time (PTT)/ Standard and Prothrombin Time

    Change from Baseline in coagulation parameter activated PTT/standard and prothrombin Time was reported.

    Measured: 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)

  21. Change From Baseline in Fibrinogen

    Change from Baseline in coagulation parameter fibrinogen was reported.

    Measured: 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)

  22. Change From Baseline in Prothrombin International Normalized Ratio

    Change from baseline in coagulation parameters prothrombin international normalized ratio was reported.

    Measured: 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)

  23. Change From Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure

    Change from Baseline in Vital Signs: Systolic Blood Pressure, Diastolic Blood Pressure was reported.

    Measured: 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)

  24. Change From Baseline in Vital Signs: Heart Rate

    Change from Baseline in Vital Signs: Heart Rate was reported.

    Measured: 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)

  25. Change From Baseline in Vital Signs: Respiratory Rate

    Change from Baseline in Vital Signs: Respiratory Rate was reported.

    Measured: 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)

  26. Change From Baseline in Vital Signs: Body Temperature

    Change from Baseline in Vital Signs: Body Temperature was reported.

    Measured: 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)

  27. Change From Baseline in Vital Signs: Body Weight

    Change from Baseline in Vital Signs: Body Weight was reported.

    Measured: 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)

  28. Change From Baseline in ECG Parameters

    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.

    Measured: At Baseline, and upto event free survival (EFS) follow up Month 18 after EOT (max on treatment increase)

  29. Treatment Duration

    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.

    Measured: Up to end of study (up to 188weeks and 5 days)

  30. Number of Participants Who Completed Cycle 1, 2, 3, 4, 5 and 6

    Number of participants who completed cycle 1, 2, 3, 4, 5 or 6 of xevinapant/matched placebo were reported.

    Measured: Cycle 1, 2, 3, 4, 5 and 6 (each cycle is of 3 weeks)

  31. Total Cumulative Dose of Xevinapant/ Matched Placebo

    Total cumulative dose of Xevinapant/ Matched Placebo was reported in form of mean and standard deviation.

    Measured: Up to end of treatment (Day 134)

  32. Total Cumulative Dose of Cisplatin

    Total cumulative dose of cisplatin was reported.

    Measured: Up to end of treatment (Day 134)

  33. Total Cumulative Dose of Carboplatin

    Total cumulative dose of carboplatin was reported as mean and standard deviation.

    Measured: Up to end of treatment (Day 134)

  34. Total Cumulative Dose of Intensity-Modulated Radiation Therapy (IMRT)

    Total cumulative dose of IMRT were reported in form of mean and standard deviation.

    Measured: Up to end of treatment (Day 134)

  35. Overall Dose Intensity of Xevinapant/Matched Placebo

    Overall dose intensity of Xevinapant/ matched placebo is calculated as the mean of the dose intensities of the individual cycles.

    Measured: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)

  36. Overall Dose Intensity of Cisplatin

    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).

    Measured: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)

  37. Overall Dose Intensity of Carboplatin

    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).

    Measured: Cycle 1, 2, 3, 4 5, 6 (each cycle is of 3 weeks) or End of Treatment (Day 134)

  38. Relative Dose Intensity

    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.

    Measured: Up to 50 months

  39. Number of Participants With Treatment Interruption, Treatment Reduction and Treatment Discontinuation for Xevinapant/ Matched Placebo

    Number of participants with Treatment Interruption, Treatment Reduction and Treatment Discontinuation was reported.

    Measured: Up to end of treatment (Day 134)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start7 Aug 2020
  3. Primary completion18 Sep 2024
  4. Study completion18 Sep 2024

Why it stopped: Study has crossed the pre-defined futility boundary at the Interim Analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459715
Sponsor's protocol ID
MS202359_0006
Other IDs
2020-000377-25, Debio 1143-SCCHN-301
Status last verified
Sep 2025
First submitted
30 Jun 2020
Last updated
8 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 40902136

  • 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.

    PubMed 35172587

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xevinapant (Debio 1143), Cisplatin and Intensity Modulation Radiation Therapy (IMRT) in people with Squamous Cell Carcinoma of the Head and Neck, run by EMD Serono Research & Development Institute, Inc. at 288 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 288 sites in United States, France, Spain, China, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459715, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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