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    Summary
    EudraCT Number:2022-001144-18
    Sponsor's Protocol Code Number:MS202359_0002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-09-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-001144-18
    A.3Full title of the trial
    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
    Estudio en fase III, aleatorizado, doble ciego, controlado con placebo, de dos grupos, para evaluar la eficacia y la seguridad de xevinapant y radioterapia en comparación con placebo y radioterapia para demostrar la mejora de la supervivencia sin enfermedad en participantes con carcinoma de células escamosas de cabeza y cuello resecado, que presentan un riesgo alto de recidiva y no son aptos para la administración de dosis altas de cisplatino.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study comparing efficacy and safety of xevinapant against placebo when given with radiotherapy in participants who had their locally advanced squamous cell carcinoma of the head and neck removed by surgery, are at high risk for the cancer to return and who cannot be treated with high-dose cisplatin.
    Un estudio clínico que comparó la eficacia y la seguridad de xevinapant con el placebo cuando se administró con radioterapia en participantes a los que se les extirpó quirúrgicamente el carcinoma de células escamosas de cabeza y cuello localmente avanzado, que tienen un alto riesgo de que el cáncer regrese y que no pueden ser tratados con -dosis de cisplatino.
    A.3.2Name or abbreviated title of the trial where available
    Phase III xevinapant and radiotherapy in resected LA SCCHN
    A.4.1Sponsor's protocol code numberMS202359_0002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Healthcare KGaA
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare KGaA
    B.5.2Functional name of contact pointCommunication Centre
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number34900 810 844
    B.5.5Fax number+496151725200
    B.5.6E-mailservice@merckgroup.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXevinapant
    D.3.2Product code MSC2735845A
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXevinapant
    D.3.9.2Current sponsor codeMSC2735845A
    D.3.9.4EV Substance CodeSUB189921
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Resected squamous cell carcinoma of the head and neck
    Carcinoma epidermoide de cabeza y cuello resecado
    E.1.1.1Medical condition in easily understood language
    Resected squamous cell carcinoma of the head and neck
    Carcinoma epidermoide de cabeza y cuello resecado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to demonstrate improvement in Disease-Free Survival (DFS) with xevinapant compared to placebo when added to RT irrespective of subsequent anticancer therapy.
    El propósito de este estudio es demostrar una mejora en la Supervivencia libre de enfermedad (DFS) con xevinapant en comparación con el placebo cuando se agrega a la RT, independientemente de la terapia contra el cáncer posterior.
    E.2.2Secondary objectives of the trial
    - To demonstrate improvement in OS with xevinapant compared to placebo when added to RT followed by subsequent anticancer therapy
    - To evaluate time to subsequent cancer treatments in participants treated with xevinapant compared to placebo when added to RT
    - To evaluate the safety and tolerability of xevinapant compared to placebo when added to RT
    - To evaluate xevinapant compared to placebo when added to RT followed by xevinapant monotherapy in terms of patient-reported head and neck pain, swallowing, and speech as measured by the EORTC H&N35 sub scales, patient-reported fatigue, physical function, and global health status as measured by the EORTC QLQ C-30 sub scales and EQ-5D-5L VAS
    -Demostrar una mejoría en la SG con xevinapant en comparación con el placebo cuando se agrega a la RT seguida de una terapia contra el cáncer posterior
    - Evaluar el tiempo hasta los tratamientos contra el cáncer posteriores en los participantes tratados con xevinapant en comparación con el placebo cuando se agrega a la RT
    - Evaluar la seguridad y la tolerabilidad de xevinapant en comparación con el placebo cuando se añade a la RT
    - Evaluar xevinapant en comparación con placebo cuando se añade a la RT seguida de monoterapia con xevinapant en términos de dolor de cabeza y cuello, deglución y habla informados por el paciente según lo medido por las subescalas EORTC H&N35, fatiga informada por el paciente, función física y salud global estado medido por las subescalas EORTC QLQ C-30 y EQ-5D-5L VAS
    E.2.3Trial contains a sub-study No
    E.3Principal 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) and 2-deoxy-2-[fluorine-18] fluoro-D-glucose positron emission tomography (18F-FDG-PET) 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: 30 < estimated glomerular filtration rate (eGFR) < 60
    milliliter per minute per 1.73 meter square (mL/min /1.73 m^2); History of hearing loss, defined as Grade >= 2 audiometric hearing loss. 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 hematologic and hepatic function as defined in the protocol
    • Other protocol-defined inclusion criteria could apply
    • Participantes con estado funcional del Grupo Oncológico Cooperativo del Este (ECOG PS) 0-1
    • Participantes con carcinoma de células escamosas confirmado histológicamente con uno de los siguientes sitios primarios: cavidad oral, orofaringe, hipofaringe o laringe. Los participantes han recibido cirugía con intención curativa en estos sitios en las últimas 4 a 8 semanas antes del inicio del tratamiento (Ciclo 1 Día 1)
    • Los participantes de orofaringe (OPC) deben tener un estado conocido del virus del papiloma humano (VPH) según lo determinado por la expresión de p16 usando inmunohistoquímica ICH)
    • Participantes sin enfermedad residual por tomografía computarizada (TC) y tomografía por emisión de positrones con 2-desoxi-2-[flúor-18] fluoro-D-glucosa (18F-FDG-PET) y tienen un alto riesgo de recaída con 1 o 2 de los siguientes criterios, confirmados por histopatología local:
    • extensión extracapsular ganglionar (ECE) y márgenes de resección positivos (R1 o margen cerrado menor o igual a (<=) 1 milímetro (mm)
    • No son aptos para recibir dosis altas de cisplatino si cumplen uno o más de los siguientes criterios: 30 < tasa de filtración glomerular estimada (TFGe) < 60
    mililitros por minuto por 1,73 metros cuadrados (ml/min/1,73 m^2); Antecedentes de pérdida auditiva, definida como pérdida auditiva audiométrica de Grado >= 2. Un
    no se requiere audiograma si uno de los otros criterios cumple con la incapacidad para recibir altas dosis de cisplatino; Neuropatía periférica > = Grado 2 y si >=
    70 años, no apto según cuestionario G8 (Puntuación <= 14)
    • Participantes con función hematológica y hepática adecuada según lo definido en el protocolo
    • Podrían aplicarse otros criterios de inclusión definidos en el protocolo
    E.4Principal 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
    • Participant with incomplete surgery
    • 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 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
    •Cualquier afección, incluido cualquier estado de enfermedad no controlada que no sea el CECC y que, en opinión del investigador constituya un riesgo inadecuado o una contraindicación para la participación en el estudio, o que pudiera interferir con los objetivos del estudio, su realización o evaluación.
    •Participante con cirugía incompleta
    •Tumor primario de la nasofaringe, los senos paranasales, la cavidad nasal, las glándulas salivales, tiroidea o paratiroidea, la piel o un lugar primario desconocido.
    • Participación en cualquier estudio clínico dentro de los 28 días anteriores a la selección o durante la participación en este estudio
    • Contraindicación conocida para someterse a una tomografía por emisión de positrones con exploraciones 18F-FDG-PET-CT, o resonancias magnéticas y tomografías computarizadas mejoradas con contraste
    • Alergia conocida a Xevinapant (Debio 1143) o a cualquier excipiente que se sepa que está presente en Xevinapant (Debio 1143) o en la formulación de placebo
    • Podrían aplicarse otros criterios de exclusión definidos en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Disease-Free Survival (DFS)
    Supervivencia libre de enfermedad (DFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to the first occurrence of death from any cause or objective disease recurrence,
    assessed up to 5 years
    Tiempo desde la aleatorización hasta el primer caso de muerte por cualquier causa o recurrencia objetiva de la enfermedad, evaluado hasta 5 años
    E.5.2Secondary end point(s)
    1. Overall Survival (OS)
    2. Time to Subsequent Cancer Treatments
    3. Number of Participants with Adverse Events (AEs) and Treatment-related AEs
    4. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score
    5. Change from Baseline in European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score
    6. Change from Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)
    1. Supervivencia general (SG)
    2. Tiempo hasta tratamientos contra el cáncer posteriores
    3. Número de participantes con eventos adversos (EA) y EA relacionados con el tratamiento
    4. Cambio desde el valor inicial en la puntuación del Módulo de cabeza y cuello de la calidad de vida del cáncer de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ-HN35)
    5. Cambio desde el valor inicial en la puntuación del Cuestionario básico de calidad de vida del cáncer de la Organización Europea para la investigación y el tratamiento del cáncer (EORTC QLQ-C30)
    6. Cambio desde el inicio en EuroQOL 5 Dimensión 5 Nivel Medida de calidad de vida relacionada con la salud Puntaje de escala analógica visual (EQ-5D-5L VAS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time from randomization to death from any cause, assessed up to 5 years
    2. Time from randomization to the start of first subsequent cancer treatment, assessed up to 5 years
    3. Time from randomization until end of study (up to 5 years)
    4. Baseline up to follow-up (5 years)
    5. Baseline up to follow-up (5 years)
    6. Baseline up to follow-up (5 years)
    1. Tiempo desde la aleatorización hasta la muerte por cualquier causa, evaluado hasta 5 años
    2. Tiempo desde la aleatorización hasta el inicio del primer tratamiento posterior contra el cáncer, evaluado hasta 5 años
    3. Tiempo desde la aleatorización hasta el final del estudio (hasta 5 años)
    4. Línea de base hasta el seguimiento (5 años)
    5. Línea de base hasta el seguimiento (5 años)
    6. Línea de base hasta el seguimiento (5 años)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    China
    India
    Israel
    Japan
    Korea, Republic of
    Mexico
    Taiwan
    United States
    Austria
    Finland
    France
    Poland
    Sweden
    Netherlands
    Romania
    Spain
    Switzerland
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Denmark
    Georgia
    Hungary
    Ireland
    Norway
    Portugal
    Turkey
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Last Visit
    Última paciente Última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 315
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 385
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 314
    F.4.2.2In the whole clinical trial 700
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants will be receiving the appropriate follow-up treatment per institutional standards.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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