Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
NCT ID: NCT05386550
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
166 participants
INTERVENTIONAL
2022-10-06
2024-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Xevinapant + IMRT
Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
Xevinapant
Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle.
IMRT
Participants received 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days per week.
Placebo + IMRT
Participants received 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 with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week 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).
IMRT
Participants received 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days per week.
Placebo
Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle.
Interventions
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Xevinapant
Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle.
IMRT
Participants received 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days per week.
Placebo
Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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University of Alabama at Birmingham - Dept of Radiation Oncology
Birmingham, Alabama, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
UC Health
Aurora, Colorado, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Perlmutter Cancer Center at NYU Langone Hospital ae Long Island
New York, New York, United States
Montefiore Medical Center Radiology
The Bronx, New York, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute, ITOR, CRU
Greenville, South Carolina, United States
Instituto de Oncologia Angel Roffo
Ciudad Autonoma Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, , Argentina
CEMAIC- Centro Medico Privado
Las Margaritas, , Argentina
Fundacion Scherbovsky
Mendoza, , Argentina
Clinica Viedma S.A.
Viedma, , Argentina
Universitatsklinikum Graz
Graz, , Austria
Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO
Linz, , Austria
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg, , Austria
Institut Jules Bordet - Medical Oncology
Anderlecht, , Belgium
Cliniques Universitaires Saint-Luc - STL
Brussels, , Belgium
Antwerp University Hospital (UZA Parent)
Edegem, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor
Barretos, , Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, , Brazil
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica
Florianópolis, , Brazil
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, , Brazil
Oncosite - Centro de Pesquisa Clinica e Oncologia
Ijuí, , Brazil
Instituto de Cancer de Londrina
Londrina, , Brazil
Liga Norte-Rio-Grandense Contra o Câncer
Natal, , Brazil
HGB - Hospital Giovanni Battista - Mãe de Deus Center
Porto Alegre, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, , Brazil
Grupo Oncoclínicas
Rio de Janeiro, , Brazil
INCA - Instituto Nacional de Câncer
Rio de Janeiro, , Brazil
Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
Salvador, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André, , Brazil
BP A Beneficencia Portuguesa da Sao Paulo
São Paulo, , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, , Brazil
Centre Hospitalier de l'Universite de Montreal.
Montreal, , Canada
Beijing Cancer Hospital
Beijing, , China
Hospital of Bengbu Medical College
Bengbu, , China
The First Hospital of Jilin University
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
Xiangya Hospital, Central South University
Changsha, , China
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital, Sichuan University
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Sir Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Anhui Provincial Cancer Hospital
Hefei, , China
Shandong Cancer Hospital
Jinan, , China
Jiangxi Cancer Hospital
Nanchang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, , China
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
Xi'an, , China
Northern Jiangsu People's Hospital
Yangzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
Olomouc, , Czechia
Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika
Prague, , Czechia
Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika
Prague, , Czechia
ICO - Site Paul Papin - service d'oncologie medicale
Angers, , France
CHU Bordeaux - Service d'Oncologie Médicale
Bordeaux, , France
CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale
Brest, , France
Centre Francois Baclesse - Service d'Oncologie Medicale
Caen, , France
Centre Georges François Leclerc - Oncologie Médicale
Dijon, , France
Hopital Prive Drome Ardeche - Service D Oncologie
Guilherand-Granges, , France
Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale
Le Mans, , France
Centre Oscar Lambret - service de cancerologie gynecologique
Lille, , France
Centre Hospitalier de Bretagne Sud
Lorient, , France
Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale
Lyon, , France
Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs
Marseille, , France
Institut Régional du Cancer de Montpellier - Service de Professeur Senesse
Montpellier, , France
Centre Azureen Cancerologie - Service De Radiotherapie
Mougins, , France
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
Nice, , France
Hopital Tenon - service radiologie et imagerie medicale
Paris, , France
Institut Curie - site de Paris - Service d'Oncologie Médicale
Paris, , France
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Poitiers, , France
Centre Henri Becquerel - Service de radiothérapie
Rouen, , France
Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie
Saint-Grégoire, , France
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain, , France
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
Strasbourg, , France
CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie
Toulon, , France
Institut Claudius Regaud - service de Radiothérapie
Toulouse, , France
CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale
Tours, , France
Institut Gustave Roussy - Oncologie Médicale
Villejuif, , France
High Technology Hospital Medcenter LLC
Batumi, , Georgia
JSC EVEX Hospitals
Kutaisi, , Georgia
Cancer Research Center Ltd.
Tbilisi, , Georgia
High Technology Medical Center, University Clinic
Tbilisi, , Georgia
LLC Todua Clinic
Tbilisi, , Georgia
New Hospitals
Tbilisi, , Georgia
Vivantes Klinikum Neukoelln - Parent
Berlin, , Germany
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und Ohrenklinik
Giessen, , Germany
Universitaetsmedizin Goettingen - Georg-August-Universität
Göttingen, , Germany
Universitaetsklinikum Jena - HNO_Klinik
Jena, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie
Kiel, , Germany
Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie
Leipzig, , Germany
Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie
Rostock, , Germany
General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens
Athens, , Greece
University General Hospital "Attikon"
Athens, , Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, , Greece
Tata Medical Centre
Kolkata, , India
National Cancer Institute Nagpur
Nagpur, , India
All India Institute of Medical Sciences
New Delhi, , India
Regional Cancer Centre
Thiruvananthapuram, , India
Soroka University Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Chaim Sheba Medical Center - pt
Ramat Gan, , Israel
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica
Brescia, , Italy
Ospedale Oncologico Armando Businco - Divisione di Oncologia Medica II
Cagliari, , Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia
Candiolo, , Italy
Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
Florence, , Italy
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo
Milan, , Italy
IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica
Milan, , Italy
Ospedale San Raffaele - U.O. di Oncologia Medica
Milan, , Italy
A.O.U. Policlinico di Modena - U.O. Oncologia
Modena, , Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
Napoli, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
Padua, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1
Roma, , Italy
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Rozzano, , Italy
Hyogo Cancer Center - Dept of Head and Neck Surgery
Akashi-shi, , Japan
National Cancer Center Hospital - Dept of Gastroenterology
Chūōku, , Japan
NHO Kyushu Cancer Center - Dept of Head and Neck Surgery
Fukuoka, , Japan
Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery
Hidaka-shi, , Japan
Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery
Hiroshima, , Japan
National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology
Kashiwa-shi, , Japan
Kagawa University Hospital - Dept of Oncology
Kita-gun, , Japan
Saitama Cancer Center - Dept of Head and Neck Surgery
Kitaadachi-gun, , Japan
Kobe University Hospital - Dept of Oncology/Hematology
Kobe, , Japan
Cancer Institute Hospital of JFCR - Dept of Medical Oncology
Kōtoku, , Japan
NHO Shikoku Cancer Center - Dept of Head and Neck Surgery
Matsuyama, , Japan
Aichi Cancer Center Hospital - Dept of Head and Neck Surgery
Nagoya, , Japan
Nagoya University Hospital - Dept of Otorhinolaryngology
Nagoya, , Japan
Okayama University Hospital - Dept of Otorhinolaryngology
Okayama, , Japan
Osaka International Cancer Institute - Dept of Head and Neck Surgery
Osaka, , Japan
Kindai University Hospital - Dept of Oncology
Osakasayama-shi, , Japan
Hokkaido University Hospital - Dept of Otorhinolaryngology
Sapporo, , Japan
NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery
Sapporo, , Japan
Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery
Sendai, , Japan
Yokohama City University Hospital - Dept of Otorhinolaryngology
Yokohama, , Japan
Hospital Civil Fray Antonio Alcalde - O.P.D. Hospital Civil de Guadalajara
Guadalajara, , Mexico
Centro de Atención e Investigación Clínica en Oncología
Mérida, , Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, , Mexico
Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen - Cancer Center
Groningen, , Netherlands
UMC Utrecht - Dept Medical Oncology
Utrecht, , Netherlands
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy - Zakład Medycyny Nuklearnej i Endokrynologii Onkolo
Gliwice, , Poland
Hospital de Braga - Serviço de Oncologia Medica
Braga, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
Centrul medical Focus
Bucharest, , Romania
S.C Medisprof S.R.L - parent
Cluj-Napoca, , Romania
S.C Radiotherapy Center Cluj S.R.L - Parent
ComunaFloresti, , Romania
S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent
Craiova, , Romania
S.C Oncocenter Oncologie Clinica S.R.L - parent
Timișoara, , Romania
Chonnam National University Hwasun Hospital
Hwasun-gun, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera
A Coruña, , Spain
Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia
A Coruña, , Spain
Hospital Clinic de Barcelona - Medical Oncology
Barcelona, , Spain
Hospital del Mar - Servicio de Oncologia
Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, , Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
Barcelona, , Spain
Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Lucus Augusti - Oncology
Lugo, , Spain
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz - Oncology
Madrid, , Spain
Hospital Universitario La Paz - Oncology Department
Madrid, , Spain
Hospital Regional Universitario de Malaga - Oncology Dept
Málaga, , Spain
Hospital Universitario Virgen del Rocio - Oncology Service
Seville, , Spain
Universitaetsspital Basel - Klinik fuer Strahlentherapie und Radioonkologie
Basel, , Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovanni
Bellinzona, , Switzerland
CHUV, Lausanne University Hospital
Lausanne, , Switzerland
Universitaetsspital Zuerich - Parent
Zurich, , Switzerland
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chi Mei Hospital, Liouying
Tainan City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan District, , Taiwan
St James's University Hospital - Dept of Oncology
Leeds, , United Kingdom
Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
London, , United Kingdom
The Christie Hospital - Dept of Oncology
Manchester, , United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Musgrove Park Hospital - PARENT
Somerset, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Torbay Hospital - PARENT
Torquay, , United Kingdom
Countries
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References
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Ferris RL, Mehanna H, Schoenfeld JD, Tahara M, Yom SS, Haddad R, Konig A, Witzler P, Bajars M, Tourneau CL. Xevinapant plus radiotherapy in resected, high-risk, cisplatin-ineligible LA SCCHN: the phase III XRay Vision study design. Future Oncol. 2024 Apr;20(12):739-748. doi: 10.2217/fon-2023-0774. Epub 2024 Jan 10.
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2022-001144-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS202359_0002
Identifier Type: -
Identifier Source: org_study_id
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