Clinical trial NCT05386550: Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
Official title: A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Adjuvant radiotherapy (RT)
Stage III
Stage IVA
Stage IVB
Oral cavity
Oropharynx
Larynx
Hypopharynx
Unfit
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2022-05-23
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.


Eligibility criteria: Inclusion Criteria:

* Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 and able to tolerate standard of care IMRT treatment according to Investigator assessment
* Participants with histologically confirmed squamous cell carcinoma with one of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx. Participants have received surgery with curative intent on these sites in the past 4 to 10 weeks before start of treatment (Cycle 1 Day 1)
* Oropharynx (OPC) participants must have known human papillomavirus (HPV) status as determined by p16 expression using immunohistochemistry (ICH)
* Participants with no residual disease by computed tomography (CT) or magnetic resonance imaging (MRI) and have a high risk of relapse with 1 or 2 of the following criteria, confirmed by local histopathology: • nodal extra-capsular extension (ECE) and positive resection margins (R1 or close margin less than or equal to (\<=) 1 millimeter (mm)
* Are unfit to receive high-dose cisplatin by meeting one or more of the following criteria: estimated glomerular filtration rate (eGFR) \< 60 milliliter per minute per 1.73 meter square (mL/min /1.73 m\^2); History of hearing impairment, defined as Grade \>= 2 audiometric hearing loss or tinnitus Grade \>= 2. An audiogram is not required if one of the other criteria meets unfitness to receive high-dose cisplatin; Peripheral neuropathy \> = Grade 2 and if \>= 70 years, unfit according to G8 questionnaire (Score \<= 14) or ineligible for cisplatin treatment due to age limit according to national guidelines
* Participants with adequate renal, hematologic and hepatic function as defined in the protocol
* Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* Any condition, including any uncontrolled disease state other than SCCHN that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
* Participants with incomplete surgery
* Participants with recurrent or metastatic disease
* Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity, salivary, thyroid or parathyroid gland, skin or unknown primary site
* Prior definitive, neoadjuvant, concurrent or adjuvant (C)RT to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents
* Participation in any interventional clinical study within 28 days prior to screening or during participation in this study
* Known contraindication to undergoing positron emission tomography with 18F-FDG-PET-CT scans, or both contrast-enhanced MRI and contrast-enhanced CT scans
* Known allergy to Xevinapant (Debio 1143) or any excipient known to be present in Xevinapant (Debio 1143) or in the placebo formulation
* Other protocol-defined exclusion criteria could apply

Primary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Time from randomization to death from any cause, assessed up to 5 years
measure: Time to Subsequent Cancer Treatments
timeFrame: Time from randomization to the start of first subsequent cancer treatment, assessed up to 5 years
measure: Number of Participants with Adverse Events (AEs) and Treatment-related AEs
timeFrame: Time from randomization until end of study (up to 5 years)
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score
timeFrame: Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)
measure: Change from Baseline in European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score
timeFrame: Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)
measure: Change from Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)
timeFrame: Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Dept of Radiation Oncology
state: Alabama
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Aurora
country: United States
facility: UC Health
state: Colorado
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center Radiology
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital ae Long Island
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Cancer Institute, ITOR, CRU
state: South Carolina
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto de Oncologia Angel Roffo
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Las Margaritas
country: Argentina
facility: CEMAIC- Centro Medico Privado
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: Viedma
country: Argentina
facility: Clinica Viedma S.A.
city: Graz
country: Austria
facility: Universitatsklinikum Graz
city: Linz
country: Austria
facility: Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet - Medical Oncology
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - STL
city: Edegem
country: Belgium
facility: Antwerp University Hospital (UZA Parent)
city: Sint-Niklaas
country: Belgium
facility: Vitaz
city: Barretos
country: Brazil
facility: Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
city: Florianópolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica
city: Fortaleza
country: Brazil
facility: CRIO - Centro Regional Integrado de Oncologia
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica e Oncologia
city: Londrina
country: Brazil
facility: Instituto de Cancer de Londrina
city: Natal
country: Brazil
facility: Liga Norte-Rio-Grandense Contra o Câncer
city: Porto Alegre
country: Brazil
facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Grupo Oncoclínicas
city: Rio de Janeiro
country: Brazil
facility: INCA - Instituto Nacional de Câncer
city: Salvador
country: Brazil
facility: Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
city: São Paulo
country: Brazil
facility: BP A Beneficencia Portuguesa da Sao Paulo
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal.
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Bengbu
country: China
facility: Hospital of Bengbu Medical College
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hangzhou
country: China
facility: Sir Run Shaw Hospital, Zhejiang University, School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
city: Shangai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika
city: Praha
country: Czechia
facility: Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika
city: Angers Cedex 2
country: France
facility: ICO - Site Paul Papin - service d'oncologie medicale
city: Bordeaux
country: France
facility: CHU Bordeaux - Service d'Oncologie Médicale
city: Brest Cedex
country: France
facility: CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale
city: Caen Cedex 05
country: France
facility: Centre Francois Baclesse - Service d'Oncologie Medicale
city: Dijon
country: France
facility: Centre Georges François Leclerc - Oncologie Médicale
city: Guilherand Granges
country: France
facility: Hopital Prive Drome Ardeche - Service D Oncologie
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale
city: Le Mans
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale
city: Lille cedex
country: France
facility: Centre Oscar Lambret - service de cancerologie gynecologique
city: Lorient cedex
country: France
facility: Centre Hospitalier de Bretagne Sud
city: Lyon
country: France
facility: Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale
city: Marseille Cedex 5
country: France
facility: Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier - Service de Professeur Senesse
city: Mougins
country: France
facility: Centre Azureen Cancerologie - Service De Radiotherapie
city: Nice cedex 02
country: France
facility: Centre Antoine Lacassagne - Service d'Hématologie Oncologie
city: Paris Cedex 05
country: France
facility: Institut Curie - site de Paris - Service d'Oncologie Médicale
city: Paris cedex
country: France
facility: Hopital Tenon - service radiologie et imagerie medicale
city: Poitiers
country: France
facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
city: Rouen
country: France
facility: Centre Henri Becquerel - Service de radiothérapie
city: Saint Grégoire
country: France
facility: Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau - Service d'Oncologie medicale
city: Strasbourg Cedex
country: France
facility: Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
city: Toulon cedex
country: France
facility: CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie
city: Toulouse cedex 09
country: France
facility: Institut Claudius Regaud - service de Radiothérapie
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy - Oncologie Médicale
city: Batumi
country: Georgia
facility: High Technology Hospital Medcenter LLC
city: Kutaisi
country: Georgia
facility: JSC EVEX Hospitals
city: Tbilisi
country: Georgia
facility: Cancer Research Center Ltd.
city: Tbilisi
country: Georgia
facility: High Technology Medical Center, University Clinic
city: Tbilisi
country: Georgia
facility: LLC Todua Clinic
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukoelln - Parent
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und Ohrenklinik
city: Goettingen
country: Germany
facility: Universitaetsmedizin Goettingen - Georg-August-Universität
city: Jena
country: Germany
facility: Universitaetsklinikum Jena - HNO_Klinik
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie
city: Athens
country: Greece
facility: General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens
city: Athens
country: Greece
facility: University General Hospital "Attikon"
city: Thessaloniki
country: Greece
facility: Interbalkan Hospital of Thessaloniki
city: Kolkata
country: India
facility: Tata Medical Centre
city: Nagpur
country: India
facility: National Cancer Institute Nagpur
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Thiruvananthapuram
country: India
facility: Regional Cancer Centre
city: Beer sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center - pt
city: Yerushalayim
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica
city: Cagliari
country: Italy
facility: Ospedale Oncologico Armando Businco - Divisione di Oncologia Medica II
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
city: Meldola
country: Italy
facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica
city: Milano
country: Italy
facility: Ospedale San Raffaele - U.O. di Oncologia Medica
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena - U.O. Oncologia
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center - Dept of Head and Neck Surgery
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital - Dept of Gastroenterology
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Cancer Center - Dept of Head and Neck Surgery
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology
city: Kita-gun
country: Japan
facility: Kagawa University Hospital - Dept of Oncology
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center - Dept of Head and Neck Surgery
city: Kobe-shi
country: Japan
facility: Kobe University Hospital - Dept of Oncology/Hematology
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR - Dept of Medical Oncology
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center - Dept of Head and Neck Surgery
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital - Dept of Head and Neck Surgery
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital - Dept of Otorhinolaryngology
city: Okayama-shi
country: Japan
facility: Okayama University Hospital - Dept of Otorhinolaryngology
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute - Dept of Head and Neck Surgery
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital - Dept of Oncology
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital - Dept of Otorhinolaryngology
city: Sapporo-shi
country: Japan
facility: NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital - Dept of Otorhinolaryngology
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde - O.P.D. Hospital Civil de Guadalajara
city: Merida
country: Mexico
facility: Centro de Atención e Investigación Clínica en Oncología
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen - Cancer Center
city: Utrecht
country: Netherlands
facility: UMC Utrecht - Dept Medical Oncology
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy - Zakład Medycyny Nuklearnej i Endokrynologii Onkolo
city: Braga
country: Portugal
facility: Hospital de Braga - Serviço de Oncologia Medica
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
city: Bucuresti
country: Romania
facility: Centrul medical Focus
city: Cluj-Napoca
country: Romania
facility: S.C Medisprof S.R.L - parent
city: ComunaFloresti
country: Romania
facility: S.C Radiotherapy Center Cluj S.R.L - Parent
city: Craiova
country: Romania
facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent
city: Timisoara
country: Romania
facility: S.C Oncocenter Oncologie Clinica S.R.L - parent
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona - Medical Oncology
city: Barcelona
country: Spain
facility: Hospital del Mar - Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Oncology Dept.
city: Barcelona
country: Spain
facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
city: Barcelona
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti - Oncology
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra (MAD) - Oncology Service
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz - Oncology
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - Oncology Department
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Oncology Dept
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - Oncology Service
city: Basel
country: Switzerland
facility: Universitaetsspital Basel - Klinik fuer Strahlentherapie und Radioonkologie
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovanni
city: Lausanne
country: Switzerland
facility: CHUV, Lausanne University Hospital
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich - Parent
city: ChangHua
country: Taiwan
facility: Changhua Christian Medical Foundation Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital,Linkou
city: Leeds
country: United Kingdom
facility: St James's University Hospital - Dept of Oncology
city: London
country: United Kingdom
facility: Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
city: Manchester
country: United Kingdom
facility: The Christie Hospital - Dept of Oncology
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Somerset
country: United Kingdom
facility: Musgrove Park Hospital - PARENT
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Torquay
country: United Kingdom
facility: Torbay Hospital - PARENT
city: Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: