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Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xevinapant (Debio 1143)
IMRT
Placebo
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Adjuvant radiotherapy (RT), Stage III, Stage IVA, Stage IVB, Oral cavity, Oropharynx, Larynx, Hypopharynx, Unfit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • 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 8 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)
  • 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 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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute
  • Montefiore Medical Center Radiology
  • Perlmutter Cancer Center at NYU Langone Hospital ae Long Island
  • University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology
  • Prisma Health Cancer Institute, ITOR, CRU
  • Centro Oncologico Riojano Integral (CORI)
  • CEMAIC - Centro Medico Privado
  • Fundacion ScherbovskyRecruiting
  • Clinica Viedma S.A.
  • Institut Jules Bordet - Medical Oncology
  • Antwerp University Hospital (UZA Parent)
  • Vitaz
  • Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de AmorRecruiting
  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa ClínicaRecruiting
  • CRIO - Centro Regional Integrado de Oncologia
  • Oncosite - Centro de Pesquisa Clinica e Oncologia
  • Liga Norte-Rio-Grandense Contra o Câncer
  • HGB - Hospital Giovanni Battista - Mãe de Deus Center
  • Irmandade da Santa Casa de Misericórdia de Porto AlegreRecruiting
  • Grupo OncoclínicasRecruiting
  • INCA - Instituto Nacional de Câncer
  • Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
  • BP A Beneficencia Portuguesa da Sao Paulo
  • Beijing Cancer HospitalRecruiting
  • Hospital of Bengbu Medical College
  • The First Hospital of Jilin University
  • Hunan Cancer HospitalRecruiting
  • Xiangya Hospital, Central South University
  • Sichuan Cancer HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Chongqing University Cancer Hospital
  • Fujian Cancer Hospital
  • Sun Yat-sen University Cancer Center
  • Sir Run Shaw Hospital, Zhejiang University, School of MedicineRecruiting
  • Zhejiang Cancer Hospital
  • Anhui Provincial Cancer Hospital
  • Shandong Cancer Hospital
  • Jiangxi Cancer Hospital
  • Nanjing Drum Tower HospitalRecruiting
  • Guangxi Medical University Affiliated Tumor HospitalRecruiting
  • Shanghai General Hospital
  • Shengjing Hospital of China Medical University
  • Tianjin Medical University Cancer Institute & Hospital
  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
  • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
  • Northern Jiangsu People's Hospital
  • Henan Cancer Hospital
  • Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
  • Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika
  • Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika
  • ICO - Site Paul Papin - service d'oncologie medicale
  • CHU Bordeaux - Service d'Oncologie Médicale
  • CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale
  • Centre Francois Baclesse - Service d'Oncologie Medicale
  • Centre Georges François Leclerc - Oncologie Médicale
  • Hopital Prive Drome Ardeche - Service D OncologieRecruiting
  • Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale
  • Centre Oscar Lambret - service de cancerologie gynecologiqueRecruiting
  • Centre Hospitalier de Bretagne Sud
  • Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale
  • Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs
  • Institut Régional du Cancer de Montpellier - Service de Professeur Senesse
  • Centre Azureen Cancerologie - Service De Radiotherapie
  • Centre Antoine Lacassagne - Service d'Hématologie Oncologie
  • Institut Curie - site de Paris - Service d'Oncologie Médicale
  • Hopital Tenon - service radiologie et imagerie medicale
  • CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
  • Centre Henri Becquerel - Service de radiothérapieRecruiting
  • Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie
  • ICO - Site René Gauducheau - Service d'Oncologie medicaleRecruiting
  • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
  • CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie
  • Institut Claudius Regaud - service de RadiothérapieRecruiting
  • CHU Tours - Hôpital Bretonneau - Service d'Oncologie MédicaleRecruiting
  • Institut Gustave Roussy - Oncologie MédicaleRecruiting
  • High Technology Hospital Medcenter LLC
  • JSC EVEX HospitalsRecruiting
  • Cancer Research Center Ltd.Recruiting
  • High Technology Medical Center, University Clinic
  • LLC Todua Clinic
  • New Hospitals
  • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und OhrenklinikRecruiting
  • Universitaetsmedizin Goettingen - Georg-August-Universität
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische RadiologieRecruiting
  • Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie
  • General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens
  • University General Hospital "Attikon"
  • Interbalkan Hospital of Thessaloniki
  • Tata Medical Centre
  • National Cancer Institute NagpurRecruiting
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica
  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed EmatologiaRecruiting
  • Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia MedicaRecruiting
  • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare
  • Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo
  • IEO Istituto Europeo di Oncologia - Divisione Oncologia MedicaRecruiting
  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
  • Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica ARecruiting
  • IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia BRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1
  • Hyogo Cancer Center - Dept of Head and Neck Surgery
  • National Cancer Center Hospital - Dept of GastroenterologyRecruiting
  • NHO Kyushu Cancer Center - Dept of Head and Neck SurgeryRecruiting
  • Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck SurgeryRecruiting
  • Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck SurgeryRecruiting
  • National Cancer Center Hospital East - Dept of Head and Neck Medical OncologyRecruiting
  • Kagawa University Hospital - Dept of Oncology
  • Saitama Cancer Center - Dept of Head and Neck Surgery
  • Kobe University Hospital - Dept of Oncology/Hematology
  • Cancer Institute Hospital of JFCR - Dept of Medical Oncology
  • NHO Shikoku Cancer Center - Dept of Head and Neck SurgeryRecruiting
  • Aichi Cancer Center Hospital - Dept of Head and Neck Surgery
  • Nagoya University Hospital - Dept of Otorhinolaryngology
  • Okayama University Hospital - Dept of Otorhinolaryngology
  • Osaka International Cancer Institute - Dept of Head and Neck SurgeryRecruiting
  • Kindai University Hospital - Dept of Oncology
  • Hokkaido University Hospital - Dept of OtorhinolaryngologyRecruiting
  • NHO Hokkaido Cancer Center - Dept of Oral Oncology SurgeryRecruiting
  • Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck SurgeryRecruiting
  • Yokohama City University Hospital - Dept of Otorhinolaryngology
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Konkuk University Medical CenterRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • The Catholic University of Korea, St. Vincent's Hospital
  • Pusan National University Yangsan HospitalRecruiting
  • Centro de Atención e Investigación Clínica en OncologíaRecruiting
  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology
  • Universitair Medisch Centrum Groningen - Cancer Center
  • UMC Utrecht - Dept Medical Oncology
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy - Zakład Medycyny Nuklearnej i Endokrynologii OnkoloRecruiting
  • Hospital de Braga - Serviço de Oncologia Medica
  • Centrul medical Focus
  • S.C Medisprof S.R.L - parentRecruiting
  • S.C Radiotherapy Center Cluj S.R.L - ParentRecruiting
  • S.C Centrul de Oncologie Sf. Nectarie S.R.L - parentRecruiting
  • S.C Oncocenter Oncologie Clinica S.R.L - parent
  • Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa HerreraRecruiting
  • Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia
  • Hospital Clinic de Barcelona - Medical Oncology
  • Hospital del Mar - Servicio de Oncologia
  • Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de OncologiaRecruiting
  • Hospital Universitario Lucus Augusti - OncologyRecruiting
  • Clinica Universidad de Navarra (MAD) - Oncology Service
  • Hospital Universitario Fundacion Jimenez Diaz - Oncology
  • Hospital Universitario La Paz - Oncology Department
  • Hospital Regional Universitario de Malaga - Oncology Dept
  • Hospital Universitario Virgen del Rocio - Oncology Service
  • Changhua Christian Medical Foundation Changhua Christian HospitalRecruiting
  • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Chi Mei Hospital, Liouying
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital,Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A: Xevinapant (Debio 1143) + IMRT

Arm B: Placebo + IMRT

Arm Description

Outcomes

Primary Outcome Measures

Disease-Free Survival (DFS)

Secondary Outcome Measures

Overall Survival (OS)
Time to Subsequent Cancer Treatments
Number of Participants with Adverse Events (AEs) and Treatment-related AEs
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score
Change from Baseline in European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score
Change from Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)

Full Information

First Posted
May 17, 2022
Last Updated
September 20, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05386550
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
October 5, 2027 (Anticipated)
Study Completion Date
December 16, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Adjuvant radiotherapy (RT), Stage III, Stage IVA, Stage IVB, Oral cavity, Oropharynx, Larynx, Hypopharynx, Unfit

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Xevinapant (Debio 1143) + IMRT
Arm Type
Experimental
Arm Title
Arm B: Placebo + IMRT
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xevinapant (Debio 1143)
Intervention Description
Participants will receive 3 cycles of oral solution of Xevinapant (Debio 1143) at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of Xevinapant (Debio 1143) at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive 3 cycles of oral solution of placebo matched to Xevinapant (Debio 1143) once daily from Day 1 to 14 per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of placebo matched to Xevinapant (Debio 1143) from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
Primary Outcome Measure Information:
Title
Disease-Free Survival (DFS)
Time Frame
Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Time from randomization to death from any cause, assessed up to 5 years
Title
Time to Subsequent Cancer Treatments
Time Frame
Time from randomization to the start of first subsequent cancer treatment, assessed up to 5 years
Title
Number of Participants with Adverse Events (AEs) and Treatment-related AEs
Time Frame
Time from randomization until end of study (up to 5 years)
Title
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score
Time Frame
Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)
Title
Change from Baseline in European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score
Time Frame
Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)
Title
Change from Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)
Time Frame
Baseline, Day 64 [at Week 10 (each cycle is 3 weeks)] and End of treatment Day 134 (at Week 20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Medical Information
Phone
888-275-7376
Email
eMediUSA@emdserono.com
First Name & Middle Initial & Last Name or Official Title & Degree
Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
sukaria@karmanos.org
First Name & Middle Initial & Last Name & Degree
Ammar W Sukari
Facility Name
Montefiore Medical Center Radiology
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
rkabarri@montefiore.org
First Name & Middle Initial & Last Name & Degree
Rafi Kabarriti
Facility Name
Perlmutter Cancer Center at NYU Langone Hospital ae Long Island
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
zujun.li@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Zujun Li
Facility Name
University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
ferrisrl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Robert Ferris
Facility Name
Prisma Health Cancer Institute, ITOR, CRU
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
richard.oneal@prismahealth.org
First Name & Middle Initial & Last Name & Degree
Richard O Neal
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Email
dlkaen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Diego Lucas Kaen
Facility Name
CEMAIC - Centro Medico Privado
City
Las Margaritas
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Email
dr.jorgeemiliosalinas@yahoo.com.ar
First Name & Middle Initial & Last Name & Degree
Jorge Emilio Salinas
Facility Name
Fundacion Scherbovsky
City
Mendoza
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Email
alejandrosola1@yahoo.com.ar
First Name & Middle Initial & Last Name & Degree
Alejandro Sola
Facility Name
Clinica Viedma S.A.
City
Viedma
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Email
kowar@rnonline.com.ar
First Name & Middle Initial & Last Name & Degree
Ruben D Kowalyszyn
Facility Name
Institut Jules Bordet - Medical Oncology
City
Anderlecht
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
Email
tatiana.dragan@hubruxelles.be
First Name & Middle Initial & Last Name & Degree
Tatiana Dragan
Facility Name
Antwerp University Hospital (UZA Parent)
City
Edegem
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
Email
marika.rasschaert@uza.be
First Name & Middle Initial & Last Name & Degree
Marika Rasschaert
Facility Name
Vitaz
City
Sint-Niklaas
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
Email
willem.lybaert@telenet.be
First Name & Middle Initial & Last Name & Degree
Willem Lybaert
Facility Name
Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor
City
Barretos
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
carlos.baston@hotmail.com
First Name & Middle Initial & Last Name & Degree
Carlos E Baston Silva
Facility Name
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
City
Curitiba
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
f.martinellioliveira@gmail.com
First Name & Middle Initial & Last Name & Degree
Fabrício Augusto Martinelli de Oliveira
Facility Name
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica
City
Florianópolis
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
fabriciopontesg@gmail.com
First Name & Middle Initial & Last Name & Degree
Fabricio Pontes Grando
Facility Name
CRIO - Centro Regional Integrado de Oncologia
City
Fortaleza
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
iane@quimioclinic.com.br
First Name & Middle Initial & Last Name & Degree
Iane F Pinto Figueiredo Lima
Facility Name
Oncosite - Centro de Pesquisa Clinica e Oncologia
City
Ijui
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
ff.oncosite@gmail.com
First Name & Middle Initial & Last Name & Degree
Fabio André Franke
Facility Name
Liga Norte-Rio-Grandense Contra o Câncer
City
Natal
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
silvio.sales@liga.org.br
First Name & Middle Initial & Last Name & Degree
Silvio C Sales
Facility Name
HGB - Hospital Giovanni Battista - Mãe de Deus Center
City
Porto Alegre
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
alanazambuja@gmail.com
First Name & Middle Initial & Last Name & Degree
Alan Arrieira Azambuja
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
katsuki.tiscoski@santacasa.org.br
First Name & Middle Initial & Last Name & Degree
Katsuki Arima Tiscoski
Facility Name
Grupo Oncoclínicas
City
Rio de Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Email
pedrodemarchi@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Pedro Rafael Martins De Marchi
Facility Name
INCA - Instituto Nacional de Câncer
City
Rio de Janeiro
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
jamillegd@gmail.com
First Name & Middle Initial & Last Name & Degree
Jamille G Dutra
Facility Name
Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
City
Salvador
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
daniel.brito@medicos.oncoclinicas.com
First Name & Middle Initial & Last Name & Degree
Daniel O Brito
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
City
Santo André
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
claudia.sette@cepho.org.br
First Name & Middle Initial & Last Name & Degree
Claudia Vaz de Melo Sette
Facility Name
BP A Beneficencia Portuguesa da Sao Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Email
lucasvsantos@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lucas Vieira dos Santos
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
lisaysun@139.com
First Name & Middle Initial & Last Name & Degree
Yan Sun
Facility Name
Hospital of Bengbu Medical College
City
Bengbu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
zoyoj79@163.com
First Name & Middle Initial & Last Name & Degree
Yajun Zhang
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
jiangx@jlu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xin Jiang
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
hanyaqiancs@163.com
First Name & Middle Initial & Last Name & Degree
Yaqian Han
Facility Name
Xiangya Hospital, Central South University
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
slf1688@sina.com
First Name & Middle Initial & Last Name & Degree
Liangfang Shen
Facility Name
Sichuan Cancer Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
freda_fm@126.com
First Name & Middle Initial & Last Name & Degree
Mei Feng
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
liuleihx@gmail.com
First Name & Middle Initial & Last Name & Degree
Lei Liu
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
344899525@qq.com
First Name & Middle Initial & Last Name & Degree
Yue Xie
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
13860603879@163.com
First Name & Middle Initial & Last Name & Degree
Shaojun Lin
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
wushx@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Shaoxiong Wu
Facility Name
Sir Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
sunxiaonan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaonan Sun
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
cxzfyun@sina.com
First Name & Middle Initial & Last Name & Degree
Xianzhong Chen
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
gjgj12123@163.com
First Name & Middle Initial & Last Name & Degree
Jin Gao
Facility Name
Shandong Cancer Hospital
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
hu5770@sina.com
First Name & Middle Initial & Last Name & Degree
Man Hu
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
lijingao@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jingao Li
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
firefreebird@163.com
First Name & Middle Initial & Last Name & Degree
Jing Yan
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
13607887386@163.com
First Name & Middle Initial & Last Name & Degree
Song Qu
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
dongpin64@aliyun.com
First Name & Middle Initial & Last Name & Degree
Pin Dong
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
zlzxlcsy@163.com
First Name & Middle Initial & Last Name & Degree
Caigang Liu
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
wpg2017@163.com
First Name & Middle Initial & Last Name & Degree
Peiguo Wang
Facility Name
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
yangky71@aliyun.com
First Name & Middle Initial & Last Name & Degree
Kunyu Yang
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mhbjdey@163.com
First Name & Middle Initial & Last Name & Degree
Hongbing Ma
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
wbhself@sina.com
First Name & Middle Initial & Last Name & Degree
Buhai Wang
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Email
wuhui7008@126.com
First Name & Middle Initial & Last Name & Degree
Hui Wu
Facility Name
Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
City
Olomouc
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
Email
bohuslav.melichar@fnol.cz
First Name & Middle Initial & Last Name & Degree
Bohuslav Melichar
Facility Name
Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika
City
Praha 10
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
Email
katerina.lickova@fnkv.cz
First Name & Middle Initial & Last Name & Degree
Katerina Lickova
Facility Name
Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika
City
Praha
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
Email
petra.holeckova@bulovka.cz
First Name & Middle Initial & Last Name & Degree
Petra Holeckova
Facility Name
ICO - Site Paul Papin - service d'oncologie medicale
City
Angers Cedex 2
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
aurore.goineau@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Aurore Goineau
Facility Name
CHU Bordeaux - Service d'Oncologie Médicale
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
amaury.daste@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Amaury Daste
Facility Name
CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale
City
Brest Cedex
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
ulrike.schick@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Ulrike Schick
Facility Name
Centre Francois Baclesse - Service d'Oncologie Medicale
City
Caen Cedex 05
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
jthariat@hotmail.com
First Name & Middle Initial & Last Name & Degree
Juliette Thariat
Facility Name
Centre Georges François Leclerc - Oncologie Médicale
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
nvulquin@cgfl.fr
First Name & Middle Initial & Last Name & Degree
Noemie Vulquin
Facility Name
Hopital Prive Drome Ardeche - Service D Oncologie
City
Guilherand Granges
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
dr.bosset@cmc-valence.org
First Name & Middle Initial & Last Name & Degree
Matthieu Bosset
Facility Name
Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale
City
Le Mans
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
essaispointreau@i-l-c.fr
First Name & Middle Initial & Last Name & Degree
Yoann Pointreau
Facility Name
Centre Oscar Lambret - service de cancerologie gynecologique
City
Lille cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
x-liem@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Xavier Liem
Facility Name
Centre Hospitalier de Bretagne Sud
City
Lorient cedex
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
c.sire@ghbs.bzh
First Name & Middle Initial & Last Name & Degree
Christian Sire
Facility Name
Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
ariane.lapierre@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Ariane Lapierre
Facility Name
Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs
City
Marseille Cedex 5
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
sebastien.salas@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Sebastien Salas
Facility Name
Institut Régional du Cancer de Montpellier - Service de Professeur Senesse
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
pierre.boisselier@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Pierre Boisselier
Facility Name
Centre Azureen Cancerologie - Service De Radiotherapie
City
Mougins
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
a.lenglet@cac-mougins.fr
First Name & Middle Initial & Last Name & Degree
Alexis Lenglet
Facility Name
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
City
Nice cedex 02
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
esma.saada-bouzid@nice.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Esma Saada-Bouzid
Facility Name
Institut Curie - site de Paris - Service d'Oncologie Médicale
City
Paris Cedex 05
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
valentin.calugaru@curie.fr
First Name & Middle Initial & Last Name & Degree
Valentin Calugaru
Facility Name
Hopital Tenon - service radiologie et imagerie medicale
City
Paris cedex
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
florence.huguet@aphp.fr
First Name & Middle Initial & Last Name & Degree
Florence Huguet
Facility Name
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
camille.evrard@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Camille Evrard
Facility Name
Centre Henri Becquerel - Service de radiothérapie
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
sebastien.thureau@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sebastien Thureau
Facility Name
Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie
City
Saint Grégoire
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
fgeriet@vivalto-sante.com
First Name & Middle Initial & Last Name & Degree
Francois Georges Riet
Facility Name
ICO - Site René Gauducheau - Service d'Oncologie medicale
City
Saint Herblain
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
frederic.rolland@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Frederic Rolland
Facility Name
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
City
Strasbourg Cedex
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
c.borel@icans.eu
First Name & Middle Initial & Last Name & Degree
Christian Borel
Facility Name
CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie
City
Toulon cedex
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
xavier.tchiknavorian@ch-toulon.fr
First Name & Middle Initial & Last Name & Degree
Xavier Tchiknavorian
Facility Name
Institut Claudius Regaud - service de Radiothérapie
City
Toulouse cedex 09
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
modesto.anouchka@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Anouchka Modesto
Facility Name
CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
s.chapet@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Sophie Chapet
Facility Name
Institut Gustave Roussy - Oncologie Médicale
City
Villejuif cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
yungan.tao@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Yungan Tao
Facility Name
High Technology Hospital Medcenter LLC
City
Batumi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
Email
tamta.makharadze@gmail.com
First Name & Middle Initial & Last Name & Degree
Tamta Makharadze
Facility Name
JSC EVEX Hospitals
City
Kutaisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Email
enatelauri@evex.ge
First Name & Middle Initial & Last Name & Degree
Eter Natelauri
Facility Name
Cancer Research Center Ltd.
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Email
am@usmle.ge
First Name & Middle Initial & Last Name & Degree
Amiran Matitashvili
Facility Name
High Technology Medical Center, University Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mirandagogishvili@yahoo.com
First Name & Middle Initial & Last Name & Degree
Miranda Gogishvili
Facility Name
LLC Todua Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
Email
tamar.melkadze@arensia-em.com
First Name & Middle Initial & Last Name & Degree
Tamar Melkadze
Facility Name
New Hospitals
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
Email
tezikogeo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Davit Giorgadze
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und Ohrenklinik
City
Giessen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
christine.langer@hno.med.uni-giessen.de
First Name & Middle Initial & Last Name & Degree
Christine Langer
Facility Name
Universitaetsmedizin Goettingen - Georg-August-Universität
City
Goettingen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
Email
rami.elshafie@med.uni-goettingen.de
First Name & Middle Initial & Last Name & Degree
Rami El Shafie
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
justus.domschikowski@uksh.de
First Name & Middle Initial & Last Name & Degree
Justus Domschikowski
Facility Name
Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie
City
Leipzig
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
Email
thomas.kuhnt@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Thomas Kuhnt
Facility Name
General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
Email
ksyrigos.trials@gmail.com
First Name & Middle Initial & Last Name & Degree
Konstantinos Syrigos
Facility Name
University General Hospital "Attikon"
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
Email
psyrri237@yahoo.com
First Name & Middle Initial & Last Name & Degree
Amanda Psyrri
Facility Name
Interbalkan Hospital of Thessaloniki
City
Thessaloniki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
Email
bakasofia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sofia Baka
Facility Name
Tata Medical Centre
City
Kolkata
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Email
sanjoy.chatterjee@tmckolkata.com
First Name & Middle Initial & Last Name & Degree
Sanjoy Chatterjee
Facility Name
National Cancer Institute Nagpur
City
Nagpur
Country
India
Individual Site Status
Recruiting
Facility Contact:
Email
abpathak21@gmail.com
First Name & Middle Initial & Last Name & Degree
Anand Pathak
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica
City
Brescia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Email
michela.buglione@unibs.it
First Name & Middle Initial & Last Name & Degree
Michela Buglione di Monale e Bastia
Facility Name
Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia
City
Candiolo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
danilo.galizia@ircc.it
First Name & Middle Initial & Last Name & Degree
Danilo Galizia
Facility Name
Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
lorenzo.livi@unifi.it
First Name & Middle Initial & Last Name & Degree
Lorenzo Livi
Facility Name
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare
City
Meldola
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Email
f.derosa@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Francesco De Rosa
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Email
lisa.licitra@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Lisa Licitra
Facility Name
IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
franco.nole@ieo.it
First Name & Middle Initial & Last Name & Degree
Franco Nole
Facility Name
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
City
Napoli
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Email
morenafasano@ymail.com
First Name & Middle Initial & Last Name & Degree
Morena Fasano
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
f.perri@istitutotumori.na.it
First Name & Middle Initial & Last Name & Degree
Francesco Perri
Facility Name
IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
City
Padova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mariagrazia.ghi@iov.veneto.it
First Name & Middle Initial & Last Name & Degree
Mariagrazia Ghi
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
andrea.botticelli@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Andrea Botticelli
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Email
vincenzo.valentini@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Vincenzo Valentini
Facility Name
Hyogo Cancer Center - Dept of Head and Neck Surgery
City
Akashi-shi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
s.iwae@hp.pref.hyogo.jp
First Name & Middle Initial & Last Name & Degree
Shigemichi Iwae
Facility Name
National Cancer Center Hospital - Dept of Gastroenterology
City
Chuo-ku
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
hirigaki@ncc.go.jp
First Name & Middle Initial & Last Name & Degree
Hiroshi Igaki
Facility Name
NHO Kyushu Cancer Center - Dept of Head and Neck Surgery
City
Fukuoka-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
sttoshny@gmail.com
First Name & Middle Initial & Last Name & Degree
Satoshi Toh
Facility Name
Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery
City
Hidaka-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
ty25811@5931.saitama-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Tomoko Yamazaki
Facility Name
Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery
City
Hiroshima-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
uedatsu@hiroshima-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Tsutomu Ueda
Facility Name
National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology
City
Kashiwa-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
matahara@east.ncc.go.jp
First Name & Middle Initial & Last Name & Degree
Makoto Tahara
Facility Name
Kagawa University Hospital - Dept of Oncology
City
Kita-gun
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
okita.yoshihiro@kagawa-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Yoshihiro Okita
Facility Name
Saitama Cancer Center - Dept of Head and Neck Surgery
City
Kitaadachi-gun
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
satohns@saitama-pho.jp
First Name & Middle Initial & Last Name & Degree
Satoshi Shirakura
Facility Name
Kobe University Hospital - Dept of Oncology/Hematology
City
Kobe-shi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
nkiyota@med.kobe-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Naomi Kiyota
Facility Name
Cancer Institute Hospital of JFCR - Dept of Medical Oncology
City
Koto-ku
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
junichi.tomomatsu@jfcr.or.jp
First Name & Middle Initial & Last Name & Degree
Junichi Tomomatsu
Facility Name
NHO Shikoku Cancer Center - Dept of Head and Neck Surgery
City
Matsuyama-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
nmonden@shikoku-cc.go.jp
First Name & Middle Initial & Last Name & Degree
Nobuya Monden
Facility Name
Aichi Cancer Center Hospital - Dept of Head and Neck Surgery
City
Nagoya-shi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
hanai@aichi-cc.jp
First Name & Middle Initial & Last Name & Degree
Nobuhiro Hanai
Facility Name
Nagoya University Hospital - Dept of Otorhinolaryngology
City
Nagoya-shi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
naokin@med.nagoya-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Naoki Nishio
Facility Name
Okayama University Hospital - Dept of Otorhinolaryngology
City
Okayama-shi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
lastnamefirstname@email.jp
First Name & Middle Initial & Last Name & Degree
Mizuo Ando
Facility Name
Osaka International Cancer Institute - Dept of Head and Neck Surgery
City
Osaka-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
fujii-ta@mc.pref.osaka.jp
First Name & Middle Initial & Last Name & Degree
Takashi Fujii
Facility Name
Kindai University Hospital - Dept of Oncology
City
Osakasayama-shi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
katanaka@med.kindai.ac.jp
First Name & Middle Initial & Last Name & Degree
Kaoru Tanaka
Facility Name
Hokkaido University Hospital - Dept of Otorhinolaryngology
City
Sapporo-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
skano@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Satoshi Kano
Facility Name
NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery
City
Sapporo-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
lastnamefirstname@email.jp
First Name & Middle Initial & Last Name & Degree
Michihiro Ueda
Facility Name
Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery
City
Sendai-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
yukio.katori.d1@tohoku.ac.jp
First Name & Middle Initial & Last Name & Degree
Yukio Katori
Facility Name
Yokohama City University Hospital - Dept of Otorhinolaryngology
City
Yokohama-shi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
noridate@yokohama-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Nobuhiko Oridate
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Email
hjnhj@hanmail.net
First Name & Middle Initial & Last Name & Degree
Hyun Jeong Shim
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Email
89367@snubh.org
First Name & Middle Initial & Last Name & Degree
Ji-Won Kim
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
irvineusa@hanmail.net
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Park
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
nobelg@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Hye Ryun Kim
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Email
meicy@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Ho Jung An
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
manic2db@gmail.com
First Name & Middle Initial & Last Name & Degree
So Yeon Oh
Facility Name
Centro de Atención e Investigación Clínica en Oncología
City
Merida
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
max010476@hotmail.com
First Name & Middle Initial & Last Name & Degree
Alejandro Molina Alavez
Facility Name
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Email
vmoyervidesjuarez@hotmail.com
First Name & Middle Initial & Last Name & Degree
Victor Manuel Oyervides Juarez
Facility Name
Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology
City
Amsterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
Email
j.buter@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Jan Buter
Facility Name
Universitair Medisch Centrum Groningen - Cancer Center
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
Email
s.oosting@umcg.nl
First Name & Middle Initial & Last Name & Degree
Sjoukje Oosting
Facility Name
UMC Utrecht - Dept Medical Oncology
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mridder5@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Mischa De Ridder
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy - Zakład Medycyny Nuklearnej i Endokrynologii Onkolo
City
Gliwice
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Email
tomr22@tlen.pl
First Name & Middle Initial & Last Name & Degree
Tomasz Rutkowski
Facility Name
Hospital de Braga - Serviço de Oncologia Medica
City
Braga
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
Email
marta.helena.almeida@gmail.com
First Name & Middle Initial & Last Name & Degree
Marta Almeida
Facility Name
Centrul medical Focus
City
Bucuresti
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mireliordan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ingrid A Iordan
Facility Name
S.C Medisprof S.R.L - parent
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
adrianudrea@medisprof.ro
First Name & Middle Initial & Last Name & Degree
Anghel Adrian Udrea
Facility Name
S.C Radiotherapy Center Cluj S.R.L - Parent
City
ComunaFloresti
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
andrei.ungureanu@amethyst-radiotherapy.com
First Name & Middle Initial & Last Name & Degree
Andrei Ungureanu
Facility Name
S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent
City
Craiova
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Email
mike_schenker@yahoo.com
First Name & Middle Initial & Last Name & Degree
Michael Schenker
Facility Name
S.C Oncocenter Oncologie Clinica S.R.L - parent
City
Timisoara
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
Email
roxana.scheusan@gmail.com
First Name & Middle Initial & Last Name & Degree
Roxana-Ioana Scheusan
Facility Name
Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera
City
A Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
aureamd@hotmail.com
First Name & Middle Initial & Last Name & Degree
Aurea Molina
Facility Name
Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia
City
A Coruña
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
aureamd@hotmail.com
First Name & Middle Initial & Last Name & Degree
Aurea Molina
Facility Name
Hospital Clinic de Barcelona - Medical Oncology
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
jjgrau@clinic.cat
First Name & Middle Initial & Last Name & Degree
Juan Jose Grau de Castro
Facility Name
Hospital del Mar - Servicio de Oncologia
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mguix@parcdesalutmar.cat
First Name & Middle Initial & Last Name & Degree
Marta Guix Arnau
Facility Name
Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia
City
Las Palmas de Gran Canaria
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
agomezdeliano84@gmail.com
First Name & Middle Initial & Last Name & Degree
Alfonso Gomez de Liaño Lista
Facility Name
Hospital Universitario Lucus Augusti - Oncology
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
alberto.carral.maseda@sergas.es
First Name & Middle Initial & Last Name & Degree
Alberto Carral Maseda
Facility Name
Clinica Universidad de Navarra (MAD) - Oncology Service
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
fserranoa@unav.es
First Name & Middle Initial & Last Name & Degree
Javier Serrano
Facility Name
Hospital Universitario Fundacion Jimenez Diaz - Oncology
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
jaime.rubiop@quironsalud.es
First Name & Middle Initial & Last Name & Degree
Jaime Rubio Perez
Facility Name
Hospital Universitario La Paz - Oncology Department
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
castelobeatriz@gmail.com
First Name & Middle Initial & Last Name & Degree
Beatriz Castelo Fernandez
Facility Name
Hospital Regional Universitario de Malaga - Oncology Dept
City
Málaga
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
rueda.dominguez@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonio Rueda Dominguez
Facility Name
Hospital Universitario Virgen del Rocio - Oncology Service
City
Sevilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mariajflor@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maria Jose Flor Oncala
Facility Name
Changhua Christian Medical Foundation Changhua Christian Hospital
City
ChangHua
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
jinchinglin@gmail.com
First Name & Middle Initial & Last Name & Degree
Jin-Ching Lin
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
kuerten@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Tai-Jan Chiu
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
joellewang66@gmail.com
First Name & Middle Initial & Last Name & Degree
Hui-Ching Wang
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
leinmirain@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ming-Yu Lien
Facility Name
Chi Mei Hospital, Liouying
City
Tainan
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
kevin640209@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Chien-Liang Lin
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
wushangyin@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Shang-Yin Wu
Facility Name
Taipei Veterans General Hospital
City
Taipei City
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
mhyang2@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Muh-Hwa Yang
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
pjlou@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Pei-Jen Lou
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Email
cgmhnog@gmail.com
First Name & Middle Initial & Last Name & Degree
Tung-Chieh Chang

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD Sharing Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD Sharing Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
IPD Sharing URL
http://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS202359_0002
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

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