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A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xevinapant (Debio 1143)
Cisplatin
Intensity Modulation Radiation Therapy (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 Squamous Cell Carcinoma of the Head and Neck focused on measuring TrilynX

Eligibility Criteria

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
  • Histologically confirmed diagnosis of previously untreated Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb according to the American Joint Committee on Cancer(AJCC))/Classification of malignant tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant metastasis (TNM) Staging System, 8th Edition.) suitable for definitive ChemoRadiotherapy (CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx
  • For OroPharyngeal Cancer (OPC) participants, primary tumors must be human papillomavirus (HPV)-negative as determined by p16 expression using immunohistochemistry
  • Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on Response evaluation criteria in solid tumors (RECIST) version 1.1
  • Peripheral neuropathy less than (<) grade 2
  • Adequate hematologic, renal and hepatic function
  • Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  • Primary tumor of nasopharynx, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site
  • Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.)
  • Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents
  • Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0 g/dL. No albumin transfusions are allowed within 2 weeks before randomization
  • Known allergy to Xevinapant (Debio 1143), cisplatin, carboplatin, other platinum-based agent or any excipient known to be present in any of these products or in the placebo formulation
  • other protocol defined exclusion criteria may apply

Sites / Locations

  • The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)
  • Banner MD Anderson Cancer Center
  • University of Arizona Cancer Center
  • UC San Diego Moores Cancer Center
  • Regents of the University of California
  • UCSF
  • The Oncology Institute of Hope & Innovation
  • University of Colorado at Denver and Health Sciences Center
  • Yale Cancer Center
  • Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
  • Moffitt Cancer Center
  • ASCLEPES Research Centers
  • Columbus Regional Research Institute
  • IACT Health, John B. Amos Cancer Center
  • Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
  • Ashland-Bellefonte Cancer Center
  • Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus
  • Massachusetts General Hospital
  • Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center
  • Dana-Farber Cancer Institute
  • University South Hospital
  • Henry Ford Health System
  • Karmanos Cancer institute
  • University of Missouri - Ellis Fischel Cancer Center
  • MidAmerica Cancer Care
  • Washington University School of Medicine
  • Comprehensive Cancer Center of Nevada (Southern Hills) (USA)
  • Comprehensive Cancer Centers of Nevada
  • NYU Langone Hospital-Long Island Oncology
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
  • NYU Grossman School of Medicine
  • Wake Forest University School of Medicine
  • University of Cincinnati Medical Center
  • University Hospital Cleveland Medical Center
  • Cleveland Clinic
  • Ohio State University
  • University of Oklahoma Health Sciences Center- Stephenson Cancer Center
  • Providence Portland Medical Center
  • Gettysburg Cancer Center
  • Fox Chase Cancer Center
  • Medical University of South Carolina- Hollings Cancer Center
  • MD Anderson
  • IHO Corporation/Utah Cancer Specialists
  • University of Virginia Medical Center
  • Hospital Aleman
  • Instituto Medico Especialazado Alexander Fleming
  • Clinica Universitaria Reina Fabiola
  • Instituto de Oncologia de Rosario
  • Clinica Viedma
  • Ashford Cancer Centre Research, Tennyson Centre
  • St Vincents Hospital
  • St Vincents Hospital Melbourne
  • Peter MacCallum Cancer Centre
  • Wollongong Hospital
  • Princess Alexandra Hospital, Cancer Trials Unit
  • Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde
  • Landeskrankenhaus Salzburg
  • Universitätsklinik für Innere Medizin III der PMU
  • Medical University of Vienna, Department of Medicine I, Division of Oncology
  • Cliniques universitaires Saint-Luc
  • Grand Hopital de Charleroi
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent UZ Gent
  • Hopital de Jolimont, Rue Ferrer
  • UZ Leuven, Radiotherapy & Oncology
  • Centre Hospitalier de l'Ardenne (CHA)
  • CHU UCL Namur Site Sainte Elisabeth
  • A.Z. Nikolaas
  • GZA Sint-Augustinus
  • Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
  • Hospital de Caridade de Ijui, Avenida David Jose Martins
  • Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
  • Centro Gaúcho Integrado, Rua Costa
  • Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
  • Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
  • National Cancer Institute
  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC
  • Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
  • Instituto do Cancer do Estado de Sao Paulo (ICESP)
  • Oswaldo Cruz German Hospital
  • London Regional Cancer Program, London Health Sciences Centre
  • CHU Montréal
  • CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont
  • Hopital Maisonneuve-Rosemont
  • CHU de Quebec-Université Laval
  • Sunnybrook Research Institute
  • Beijing Cancer Hospital
  • Peking Union Medical College Hospital
  • Jilin Cancer Hospital
  • Hunan Cancer Hospital
  • Xiangya Hospital Central South University
  • West China Hospital of Sichuan University
  • Fujian Cancer Hospital
  • The 5th Affiliated Hospital of Sun yet-sen university
  • The 2nd Affiliated Hospital of Zhejiang University School of Medicine
  • Zhejiang Province Cancer Hospital
  • Harbin Medical University Cancer Hospital
  • Affiliated Tumor Hospital of Guangxi Medical University
  • Lin Yi Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Shanghai Ninth People's Hospital
  • Shantou University Cancer Hospital
  • Liaoning Cancer Hospital & institute
  • Tianjin Medical University Cancer Institute & Hospital
  • Tongji Hospital/Tongji Medical College, Huazhong University of Science
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Henan Cancer Hospital
  • University Hospital hradec Kralové
  • Fakultni Nemocnice Ostrava
  • Hospital Na Bulovce
  • KOC KNTB a.s. Zlín
  • CHU Amiens Picardie - Hopital Sud
  • Institut de Cancérologie de l Ouest (ICO)
  • Institut Sainte Catherine
  • Centre hospitalier Universitaire de Bordeaux
  • CHRU de Brest Hopital Morvan
  • Centre Jean Perrin CLCC
  • CHU de Grenoble
  • Centre Guillaume Le Conquerant
  • Clinique Victor Hugo
  • Centre hospitalier Libourne
  • Centre Oscar Lambret
  • Hôpital du Scorff
  • Centre Leon Berard
  • Service d'Oncologie Médicale, CHU Timone
  • Hôpital Nord Franche Comté
  • Institut Regional du Cancer de Montpellier
  • LHopital prive du Confluent Nantes
  • CCConcorde (GCS)
  • Centre Antoine Lacassagne
  • CHU Nimes
  • Institut Curie
  • Centre Eugène Marquis
  • Centre Henri Becquerel CLCC
  • CHP Saint Gregoire FINESS
  • Institut de Cancérologie de l'Ouest - Site Saint Herblain
  • ICANS
  • Institut Claudius Regaud - IUCT-O
  • CHU de Tours
  • The Public Hospital L'Institut de Cancerologie de Lorraine
  • Institut Gustave Roussy - Service de radiotherapie
  • Evex Hospitals Oncology Center
  • Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
  • Cancer Research Cent 4
  • Institute of Clinical Oncology
  • JSC "Evex Hospitals"
  • LEPL First University Clinic of Tbilisi State Medical University
  • New Hospitals
  • CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie
  • Charité - Universitätsmedizin Berlin Campus Virchow
  • Strahlenklinik des Uni-Klinikums
  • Department of radiation oncology, University Hospital Essen
  • Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie
  • Universitätsklinikum Hamburg-Eppendorf
  • University Medical Center Schleswig-Holstein, Campus Kiel
  • Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie
  • Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
  • Universitaetsklinikum Regensburg
  • Universitaetsmedizin Rostock
  • Agioi Anargiroi General Oncology Hospital of Kifissia
  • Attikon University Hospital
  • Theagenio Anticancer Hospital
  • Orszagos Onkologiai Intezet Sugarterapias Osztaly
  • Uzsoki Utcai Korhaz Onkologiai Osztaly
  • Petz Aladár Megyei Kórház Onkoradiológiai Osztály
  • Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet
  • Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika
  • Rambam Healthcare Campus
  • Research Fund of the Hadassah Medical Organization
  • Rabin Medical Center
  • Sheba Medical Center
  • Centro di Riferimento Oncologico
  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
  • Istituto di Candiolo IRCCS
  • Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle
  • Azienda Ospedaliero-Universitaria Careggi
  • IRCCS AOU San Martino
  • Ospedale "Vito Fazzi" Lecce
  • Az. USL 6 Ospedali Riuniti-Ospedale di Livorno
  • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
  • IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO
  • Istituto Nazionale dei Tumori
  • Policlinico di Modena
  • AORN Ospedale dei Monaldi
  • AOU "Luigi Vanvitelli"
  • Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale"
  • Istituto Oncologico Veneto Irccs
  • Azienda Ospedaliero Universitaria di Parma
  • Fondazione Policlinico Universitario Agostino Gemelli
  • ASL2_Presidio Ospedaliero San Paolo
  • National Cancer Center Hospital East
  • National Cancer Center Hospital
  • Saitama Medical University International Medical Center
  • Hyogo Cancer Center
  • University Hospital Kyoto Prefectural University of Medicine
  • Tokai University Hospital
  • Hokkaido University Hospital
  • Okayama University Hospital
  • Kobe University Hospital
  • Cancer Institute Hospital of JFCR
  • National Hospital Organization Shikoku Cancer Center
  • Shizuoka Cancer Center
  • Osaka International Cancer Institute
  • Tokyo Medical University Hospital
  • Pusan National University Hospital
  • National Cancer Center Hematologic Oncology
  • National Cancer Center
  • Asan Medical Center, Asian Cacer Center
  • Asan Medical Center
  • KonKuk University Medical Center
  • Korea University Anam Hospital
  • Seoul National University Boramae Medical Center
  • Pusan National University Yangsan Hospital, Oncol & Hematology
  • Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii
  • Szpitale Pomorskie Sp. z o.o.
  • Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
  • SP ZOZ MSWiA z W-M CO w Olsztynie
  • NZOZ Provita Prolife Centrum Medyczne
  • Centro Clinico Academico
  • Hospital de Braga
  • Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
  • Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)
  • Centro Hospitalar Universitário Lisboa Norte
  • Centro Hospitalar de Vila Nova de Gaia/Espinho
  • Centro Hospitalar Universitario São João
  • Hospital Pedro Hispano
  • Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E
  • State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"
  • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky
  • Kursk Regional Clinical Oncology Dispensary
  • FGBU N.N.Blokhin Russian Cancer Research Center
  • EuroCityClinic
  • Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
  • FSBI National Med Research Cancer Center N.N. Petrov
  • Republican Clinical Oncological Dispensary of Bashkortostan
  • State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)
  • State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital
  • Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro"
  • Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro
  • Hospital Clinic Barcelona
  • Hospital del Mar
  • Hospital Universitari Vall d'Hebron
  • Institut Català d'Oncologia Badalona
  • Institut Català d'Oncologia, Hospital Duran
  • Institut Universitari Dexeus-Quiron (ESP)
  • Hospital Reina Sofía
  • Institut Català d'Oncologia
  • Hospital Universitario Insular de Gran Canaria
  • Clinica Universidad de Navarra
  • Hospital 12 de Octubre
  • Hospital Clinico San Carlos
  • Hospital Ramon y Cajal
  • Hospital Universitario HM Sanchinarro
  • Hospital Universitario La Paz
  • Althaia, Xarxa Assistencial
  • Fundacio Althaia
  • Hospital Civil (Hospital Regional Universitario)
  • Clinica Universidad de Navarra
  • Hospital Universitario Marqués de Valdecilla. Santander
  • Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)
  • Hospital Universitario La Fe
  • IVO
  • Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
  • Hopitaux Universitaires de Geneve
  • Centre Hospitalier Universitaire Vaudois Lausanne
  • Chang-Gung Memorial Hospital-Kaohsiung
  • Kaohsiung Medical University Memorial Hospital
  • Taichung Veterans General Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital (VGHTP)
  • Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital
  • Medical center ASKLEPION LLC
  • Kiev City Clinical Oncology Centre
  • Medical center of Yuriy Spizhenko, Soborna Vulytsia
  • Aberdeen Royal infirmary, Dept. of Oncology
  • Royal Marsden NHS Foundation Trust
  • NHS Greater Glasgow and Clyde
  • Royal Surrey County Hospital
  • Charing Cross Hospital
  • The Christie NHS Foundation Trust
  • Mount Vernon Cancer Centre
  • Nottingham University Hospitals NHS Trust
  • University Hospital Southampton NHS Foundation Trust
  • The Royal Marsden NHS Foundation Trust - Sutton
  • Clatterbridge Cancer Centre NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xevinapant (Debio 1143)

Placebo

Arm Description

Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Xevinapant (Debio 1143) Monotherapy period (Cycles 4-6): • Xevinapant (Debio 1143)

Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo

Outcomes

Primary Outcome Measures

Event-Free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of disease progression or death.

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2020
Last Updated
October 23, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
GORTEC (Head and Neck Oncology and Radiotherapy Group), Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04459715
Brief Title
A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
Official Title
A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
GORTEC (Head and Neck Oncology and Radiotherapy Group), Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
TrilynX

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Xevinapant (Debio 1143)
Arm Type
Experimental
Arm Description
Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Xevinapant (Debio 1143) Monotherapy period (Cycles 4-6): • Xevinapant (Debio 1143)
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo
Intervention Type
Drug
Intervention Name(s)
Xevinapant (Debio 1143)
Intervention Description
Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin administered as an IV infusion every 3 weeks (Q3W).
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulation Radiation Therapy (IMRT)
Intervention Description
70 Gy given in 35 fractions over 7 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS)
Description
EFS is the time from the date of randomization to the date of first record of disease progression or death.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS is the time from randomization to death due to any cause.
Time Frame
Up to 5 years
Title
Progression-Free Survival (PFS)
Description
PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)
Time Frame
Up to 5 years
Title
Locoregional Control (LRC)
Time Frame
From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years)
Title
Objective Response Rate (ORR)
Description
ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).
Time Frame
Up to 5 years
Title
Complete Response Rate (CRR)
Description
CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).
Time Frame
Up to 5 years
Title
Duration of Response (DOR)
Description
Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.
Time Frame
Up to 5 years
Title
Number of Participants with Radical Salvage Surgery
Time Frame
Up to 5 years
Title
Time to Subsequent Systemic Cancer Treatments
Time Frame
Up to 5 years
Title
Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure
Time Frame
From signed informed consent to EOS (within 6.8 years)
Title
Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
Description
Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)
Time Frame
Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
Title
Changes from Baseline in Swallowing and Pain Symptoms
Description
Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)
Time Frame
Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 Histologically confirmed diagnosis of previously untreated Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb according to the American Joint Committee on Cancer(AJCC))/Classification of malignant tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant metastasis (TNM) Staging System, 8th Edition.) suitable for definitive ChemoRadiotherapy (CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx For OroPharyngeal Cancer (OPC) participants, primary tumors must be human papillomavirus (HPV)-negative as determined by p16 expression using immunohistochemistry Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on Response evaluation criteria in solid tumors (RECIST) version 1.1 Peripheral neuropathy less than (<) grade 2 Adequate hematologic, renal and hepatic function Other protocol defined inclusion criteria may apply Exclusion Criteria: Primary tumor of nasopharynx, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.) Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0 g/dL. No albumin transfusions are allowed within 2 weeks before randomization Known allergy to Xevinapant (Debio 1143), cisplatin, carboplatin, other platinum-based agent or any excipient known to be present in any of these products or in the placebo formulation other protocol defined exclusion criteria may apply
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
The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Regents of the University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
The Oncology Institute of Hope & Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
University of Colorado at Denver and Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
ASCLEPES Research Centers
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
IACT Health, John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Ashland-Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
Facility Name
Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University South Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-9001
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Karmanos Cancer institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
University of Missouri - Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
MidAmerica Cancer Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Comprehensive Cancer Center of Nevada (Southern Hills) (USA)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
NYU Langone Hospital-Long Island Oncology
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Grossman School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospital Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Health Sciences Center- Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Medical University of South Carolina- Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
IHO Corporation/Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Hospital Aleman
City
Buenos Aires
Country
Argentina
Facility Name
Instituto Medico Especialazado Alexander Fleming
City
Buenos Aires
Country
Argentina
Facility Name
Clinica Universitaria Reina Fabiola
City
Cordoba
Country
Argentina
Facility Name
Instituto de Oncologia de Rosario
City
Santa Fe
Country
Argentina
Facility Name
Clinica Viedma
City
Viedma
Country
Argentina
Facility Name
Ashford Cancer Centre Research, Tennyson Centre
City
Adelaide
Country
Australia
Facility Name
St Vincents Hospital
City
Darlinghurst
Country
Australia
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
Country
Australia
Facility Name
Wollongong Hospital
City
Wollongong
Country
Australia
Facility Name
Princess Alexandra Hospital, Cancer Trials Unit
City
Woolloongabba
Country
Australia
Facility Name
Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde
City
Graz
Country
Austria
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin III der PMU
City
Salzburg
Country
Austria
Facility Name
Medical University of Vienna, Department of Medicine I, Division of Oncology
City
Vienna
Country
Austria
Facility Name
Cliniques universitaires Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
Grand Hopital de Charleroi
City
Charleroi
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent UZ Gent
City
Gent
Country
Belgium
Facility Name
Hopital de Jolimont, Rue Ferrer
City
La Louvière
Country
Belgium
Facility Name
UZ Leuven, Radiotherapy & Oncology
City
Leuven
Country
Belgium
Facility Name
Centre Hospitalier de l'Ardenne (CHA)
City
Libramont
Country
Belgium
Facility Name
CHU UCL Namur Site Sainte Elisabeth
City
Namur
Country
Belgium
Facility Name
A.Z. Nikolaas
City
Sint-Niklaas
Country
Belgium
Facility Name
GZA Sint-Augustinus
City
Wilrijk
Country
Belgium
Facility Name
Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
City
Barretos
Country
Brazil
Facility Name
Hospital de Caridade de Ijui, Avenida David Jose Martins
City
Ijuí
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
City
Natal
Country
Brazil
Facility Name
Centro Gaúcho Integrado, Rua Costa
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
City
Porto Alegre
Country
Brazil
Facility Name
National Cancer Institute
City
Rio De Janeiro
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC
City
Santo André
Country
Brazil
Facility Name
Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
City
São José Do Rio Preto
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo (ICESP)
City
São Paulo
Country
Brazil
Facility Name
Oswaldo Cruz German Hospital
City
São Paulo
Country
Brazil
Facility Name
London Regional Cancer Program, London Health Sciences Centre
City
London
Country
Canada
Facility Name
CHU Montréal
City
Montreal
Country
Canada
Facility Name
CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont
City
Montreal
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
Country
Canada
Facility Name
CHU de Quebec-Université Laval
City
Québec
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
Country
Canada
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Facility Name
The 5th Affiliated Hospital of Sun yet-sen university
City
Guangdong
Country
China
Facility Name
The 2nd Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
Zhejiang Province Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
Country
China
Facility Name
Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
Country
China
Facility Name
Lin Yi Cancer Hospital
City
Shandong
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
Country
China
Facility Name
Shantou University Cancer Hospital
City
Shantou
Country
China
Facility Name
Liaoning Cancer Hospital & institute
City
Shenyang
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
Country
China
Facility Name
Tongji Hospital/Tongji Medical College, Huazhong University of Science
City
Wuhan
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Facility Name
University Hospital hradec Kralové
City
Hradec Králové
Country
Czechia
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava-Poruba
Country
Czechia
Facility Name
Hospital Na Bulovce
City
Prague
Country
Czechia
Facility Name
KOC KNTB a.s. Zlín
City
Zlín
Country
Czechia
Facility Name
CHU Amiens Picardie - Hopital Sud
City
Amiens
Country
France
Facility Name
Institut de Cancérologie de l Ouest (ICO)
City
Angers
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon Cedex 9
Country
France
Facility Name
Centre hospitalier Universitaire de Bordeaux
City
Bordeaux
Country
France
Facility Name
CHRU de Brest Hopital Morvan
City
Brest
Country
France
Facility Name
Centre Jean Perrin CLCC
City
Clermont Ferrand
Country
France
Facility Name
CHU de Grenoble
City
Grenoble Cedex 9
Country
France
Facility Name
Centre Guillaume Le Conquerant
City
le Havre
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
Country
France
Facility Name
Centre hospitalier Libourne
City
Libourne
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Hôpital du Scorff
City
Lorient
Country
France
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Facility Name
Service d'Oncologie Médicale, CHU Timone
City
Marseille
Country
France
Facility Name
Hôpital Nord Franche Comté
City
Montbeliard
Country
France
Facility Name
Institut Regional du Cancer de Montpellier
City
Montpellier
Country
France
Facility Name
LHopital prive du Confluent Nantes
City
Nantes Cedex 2
Country
France
Facility Name
CCConcorde (GCS)
City
Neuilly sur Seine
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
CHU Nimes
City
Nimes
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes Cedex
Country
France
Facility Name
Centre Henri Becquerel CLCC
City
Rouen Cedex
Country
France
Facility Name
CHP Saint Gregoire FINESS
City
Saint Gregoire
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Site Saint Herblain
City
Saint Herblain
Country
France
Facility Name
ICANS
City
Strasbourg
Country
France
Facility Name
Institut Claudius Regaud - IUCT-O
City
Toulouse
Country
France
Facility Name
CHU de Tours
City
Tours
Country
France
Facility Name
The Public Hospital L'Institut de Cancerologie de Lorraine
City
Vandoeuvre les Nancy
Country
France
Facility Name
Institut Gustave Roussy - Service de radiotherapie
City
Villejuif
Country
France
Facility Name
Evex Hospitals Oncology Center
City
Kutaisi
Country
Georgia
Facility Name
Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
City
Tbilisi
Country
Georgia
Facility Name
Cancer Research Cent 4
City
Tbilisi
Country
Georgia
Facility Name
Institute of Clinical Oncology
City
Tbilisi
Country
Georgia
Facility Name
JSC "Evex Hospitals"
City
Tbilisi
Country
Georgia
Facility Name
LEPL First University Clinic of Tbilisi State Medical University
City
Tbilisi
Country
Georgia
Facility Name
New Hospitals
City
Tbilisi
Country
Georgia
Facility Name
CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie
City
Berlin
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin Campus Virchow
City
Berlin
Country
Germany
Facility Name
Strahlenklinik des Uni-Klinikums
City
Erlangen
Country
Germany
Facility Name
Department of radiation oncology, University Hospital Essen
City
Essen
Country
Germany
Facility Name
Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
University Medical Center Schleswig-Holstein, Campus Kiel
City
Kiel
Country
Germany
Facility Name
Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie
City
Leipzig
Country
Germany
Facility Name
Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
City
Mannheim
Country
Germany
Facility Name
Universitaetsklinikum Regensburg
City
Regensburg
Country
Germany
Facility Name
Universitaetsmedizin Rostock
City
Rostock
Country
Germany
Facility Name
Agioi Anargiroi General Oncology Hospital of Kifissia
City
Athens
Country
Greece
Facility Name
Attikon University Hospital
City
Athens
Country
Greece
Facility Name
Theagenio Anticancer Hospital
City
Thessaloníki
Country
Greece
Facility Name
Orszagos Onkologiai Intezet Sugarterapias Osztaly
City
Budapest
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz Onkologiai Osztaly
City
Budapest
Country
Hungary
Facility Name
Petz Aladár Megyei Kórház Onkoradiológiai Osztály
City
Győr
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet
City
Pécs
Country
Hungary
Facility Name
Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika
City
Szeged
Country
Hungary
Facility Name
Rambam Healthcare Campus
City
Haifa
Country
Israel
Facility Name
Research Fund of the Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tiqva
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Centro di Riferimento Oncologico
City
Aviano
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Istituto di Candiolo IRCCS
City
Candiolo
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle
City
Cuneo
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
IRCCS AOU San Martino
City
Genova
Country
Italy
Facility Name
Ospedale "Vito Fazzi" Lecce
City
Lecce
Country
Italy
Facility Name
Az. USL 6 Ospedali Riuniti-Ospedale di Livorno
City
Livorno
Country
Italy
Facility Name
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
City
Meldola
Country
Italy
Facility Name
IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO
City
Milan
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Milan
Country
Italy
Facility Name
Policlinico di Modena
City
Modena
Country
Italy
Facility Name
AORN Ospedale dei Monaldi
City
Napoli
Country
Italy
Facility Name
AOU "Luigi Vanvitelli"
City
Napoli
Country
Italy
Facility Name
Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale"
City
Napoli
Country
Italy
Facility Name
Istituto Oncologico Veneto Irccs
City
Padova
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Rome
Country
Italy
Facility Name
ASL2_Presidio Ospedaliero San Paolo
City
Savona
Country
Italy
Facility Name
National Cancer Center Hospital East
City
Chiba
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku Tokyo
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
Country
Japan
Facility Name
Hyogo Cancer Center
City
Hyogo
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kamigyo-ku
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
Country
Japan
Facility Name
Hokkaido University Hospital
City
Kita-Ku
Country
Japan
Facility Name
Okayama University Hospital
City
Kita-ku
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-ku
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Nagaizumi-cho
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
National Cancer Center Hematologic Oncology
City
Goyang-si
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
Country
Korea, Republic of
Facility Name
Asan Medical Center, Asian Cacer Center
City
Seoul
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
KonKuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital, Oncol & Hematology
City
Yangsan
Country
Korea, Republic of
Facility Name
Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii
City
Gdańsk
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
Country
Poland
Facility Name
Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
City
Gliwice
Country
Poland
Facility Name
SP ZOZ MSWiA z W-M CO w Olsztynie
City
Olsztyn
Country
Poland
Facility Name
NZOZ Provita Prolife Centrum Medyczne
City
Łódź
Country
Poland
Facility Name
Centro Clinico Academico
City
Braga
Country
Portugal
Facility Name
Hospital de Braga
City
Braga
Country
Portugal
Facility Name
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
City
Coimbra
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)
City
Faro
Country
Portugal
Facility Name
Centro Hospitalar Universitário Lisboa Norte
City
Lissabon
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho
City
Porto
Country
Portugal
Facility Name
Centro Hospitalar Universitario São João
City
Porto
Country
Portugal
Facility Name
Hospital Pedro Hispano
City
Porto
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E
City
Porto
Country
Portugal
Facility Name
State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"
City
Kazan
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Kursk Regional Clinical Oncology Dispensary
City
Kursk
Country
Russian Federation
Facility Name
FGBU N.N.Blokhin Russian Cancer Research Center
City
Moscow
Country
Russian Federation
Facility Name
EuroCityClinic
City
Saint Petersburg
Country
Russian Federation
Facility Name
Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
City
Saint Petersburg
Country
Russian Federation
Facility Name
FSBI National Med Research Cancer Center N.N. Petrov
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Republican Clinical Oncological Dispensary of Bashkortostan
City
Ufa
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)
City
Ufa
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital
City
Yaroslavl
Country
Russian Federation
Facility Name
Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro"
City
A Coruña
State/Province
Galicia
Country
Spain
Facility Name
Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro
City
A Coruna
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Institut Català d'Oncologia Badalona
City
Barcelona
Country
Spain
Facility Name
Institut Català d'Oncologia, Hospital Duran
City
Barcelona
Country
Spain
Facility Name
Institut Universitari Dexeus-Quiron (ESP)
City
Barcelona
Country
Spain
Facility Name
Hospital Reina Sofía
City
Cordoba
Country
Spain
Facility Name
Institut Català d'Oncologia
City
Girona
Country
Spain
Facility Name
Hospital Universitario Insular de Gran Canaria
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Madrid
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Althaia, Xarxa Assistencial
City
Manresa
Country
Spain
Facility Name
Fundacio Althaia
City
Manresa
Country
Spain
Facility Name
Hospital Civil (Hospital Regional Universitario)
City
Málaga
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla. Santander
City
Santander
Country
Spain
Facility Name
Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)
City
Valencia
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
IVO
City
Valencia
Country
Spain
Facility Name
Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
City
Bern
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois Lausanne
City
Lausanne
Country
Switzerland
Facility Name
Chang-Gung Memorial Hospital-Kaohsiung
City
Kaohsiung City
Country
Taiwan
Facility Name
Kaohsiung Medical University Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung City
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital (VGHTP)
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital
City
Taoyuan City
Country
Taiwan
Facility Name
Medical center ASKLEPION LLC
City
Khodosivka
Country
Ukraine
Facility Name
Kiev City Clinical Oncology Centre
City
Kiev
Country
Ukraine
Facility Name
Medical center of Yuriy Spizhenko, Soborna Vulytsia
City
Kyiv
Country
Ukraine
Facility Name
Aberdeen Royal infirmary, Dept. of Oncology
City
Aberdeen
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
Chelsea
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust - Sutton
City
Sutton
Country
United Kingdom
Facility Name
Clatterbridge Cancer Centre NHS Foundation Trust
City
Wirral
Country
United Kingdom

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
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 URL
http://bit.ly/IPD21
Citations:
PubMed Identifier
35172587
Citation
Bourhis J, Burtness B, Licitra LF, Nutting C, Schoenfeld JD, Omar M, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen EE. Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design. Future Oncol. 2022 May;18(14):1669-1678. doi: 10.2217/fon-2021-1634. Epub 2022 Feb 17.
Results Reference
derived
Links:
URL
https://clinicaltrials.emdgroup.com/en/
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

A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

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