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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04459715
Other study ID # MS202359_0006
Secondary ID 2020-000377-25De
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 7, 2020
Est. completion date April 30, 2027

Study information

Verified date June 2024
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 730
Est. completion date April 30, 2027
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
EMD Serono Research & Development Institute, Inc. GORTEC (Head and Neck Oncology and Radiotherapy Group), Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Spain,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

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