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    Summary
    EudraCT Number:2021-004453-23
    Sponsor's Protocol Code Number:R3767-ONC-2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-13
    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 number2021-004453-23
    A.3Full title of the trial
    A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA
    Estudio de fase III de fianlimab (REGN3767, anti-LAG-3) + cemiplimab en comparación con pembrolizumab en pacientes con melanoma metastásico o localmente avanzado inoperable no tratado previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of Fianlimab in combination with Cemiplimab in patients with previously untreated unresectable locally advanced or metastatic melanoma.
    Estudio clínico de fianlimab en combinación con cemiplimab en pacientes con melanoma metastásico o localmente avanzado inoperable no tratado previamente.
    A.4.1Sponsor's protocol code numberR3767-ONC-2011
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 nameFianlimab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFIANLIMAB
    D.3.9.2Current sponsor codeREGN3767
    D.3.9.4EV Substance CodeSUB198168
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Libtayo
    D.2.1.1.2Name of the Marketing Authorisation holderRegeneron Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCemiplimab
    D.3.2Product code REGN2810
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCemiplimab
    D.3.9.1CAS number 1801342-60-8
    D.3.9.4EV Substance CodeSUB189482
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameKeytruda
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cutaneous Melanoma
    Melanoma cutáneo
    E.1.1.1Medical condition in easily understood language
    Cutaneous melanoma is one of the most aggressive forms of skin cancer
    El melanoma cutáneo es una de las formas más agresivas de cáncer de piel
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025650
    E.1.2Term Malignant melanoma
    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
    To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by PFS (progression-free survival).
    Demostrar la superioridad de fianlimab + cemiplimab en comparación con pembrolizumab, medida por la supervivencia sin progresión (SSP).
    E.2.2Secondary objectives of the trial
    - Demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by OS (overall survival)
    - Demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab
    - Characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component
    - Assess immunogenicity of fianlimab and cemiplimab
    - Assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults
    - Characterize safety and tolerability of treatment in patients 12 to <18 years of age
    - Characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age
    - Assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab
    - Characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years
    -Demostrar superioridad de fianlimab (REGN3767)+cemiplimab en comparación con pembrolizumab,medida por supervivencia general (SG).
    -Demostrar superioridad en tasa de respuesta objetiva con fianlimab+cemiplimab en comparación con pembrolizumab.
    -Caracterizar TRO,SSP y SG con fianlimab+cemiplimab en comparación con cemiplimab para informar sobre la contribución de cada componente.
    -Evaluar inmunogenia de fianlimab y cemiplimab.
    -Evaluar impacto de fianlimab+cemiplimab en funcionamiento físico y de roles,así como calidad de vida o estado salud global,en comparación con pembrolizumab en adultos.
    -Caracterizar la seguridad y la tolerabilidad del tratamiento en pacientes de 12 a <18 años.
    -Caracterizar la TRO,la SSP y la SG con tratamiento en pacientes de 12 a <18 años.
    -Evaluar seguridad y tolerabilidad de fianlimab+cemiplimab en comparación con pembrolizumab y con cemiplimab.
    -Caracterizar farmacocinética del tratamiento mediante muestreo disperso de FC en pacientes de ≥12 años.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥12 years on the date of providing informed consent
    2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease.
    a. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable irAEs ≥ Grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement ) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months.
    b. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
    3. Measurable disease per RECIST v1.1
    a. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
    b. Cutaneous lesions should be evaluated as non-target lesions
    4. Performance status:
    a) For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
    b) For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients <16 years)
    5. Anticipated life expectancy of at least 3 months.

    Please note other protocol-defined Inclusion criteria apply
    1. Edad ≥12 años en la fecha en la que se proporcione el consentimiento informado.
    2. Pacientes con melanoma irresecable confirmado mediante análisis histológico en estadio III y estadio IV (metastásico) (AJCC, octava edición revisada) que no han recibido tratamiento sistémico previo para la enfermedad avanzada irresecable.
    a. Los pacientes que hayan recibido terapias sistémicas adyuvantes o neoadyuvantes son idóneos si no han mostrado signos de progresión o recidiva de la enfermedad y/o si han interrumpido el tratamiento debido a la aparición de AA incontrolables grado ≥3 mientras recibían dichas terapias. Además, los pacientes deben haber tenido un intervalo libre de tratamiento y enfermedad de >6 meses.
    b. Los pacientes con melanomas acrales y mucosos son idóneos. Podrán participar hasta representar aproximadamente un 10 % de la población total.
    3. Enfermedad mensurable mediante los criterios RECIST v1.1.
    a. Las lesiones previamente irradiadas solo pueden contarse como lesiones diana si se ha demostrado que progresan y no hay otra lesión diana.
    b. Las lesiones cutáneas deben evaluarse como lesiones no diana.
    4. Estado funcional:
    a) Pacientes adultos: Estado funcional del Eastern Cooperative Oncology Group (ECOG) 0 o 1.
    b) Pacientes pediátricos: Estado funcional de Karnofsky ≥70 (pacientes ≥16 años) o estado funcional de Lansky ≥70 (pacientes <16 años).
    5. Esperanza de vida prevista de al menos 3 meses
    E.4Principal exclusion criteria
    Medical conditions:
    1. Uveal melanoma
    2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
    3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
    4. Unknown BRAF V600 mutation status.
    Prior/concomitant therapy:
    5. Systemic immune suppression:
    a. Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, provided if they are not for treatment of an autoimmune disorder.
    b. Other clinically relevant forms of systemic immune suppression.
    6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, radiotherapy, major surgery or biological therapy within 3 weeks prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
    Other comorbidities:
    7. History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
    8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
    a. received radiotherapy or another appropriate standard therapy for the brain metastases,
    b. have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment.
    c. did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment.
    d. are asymptomatic with a single untreated brain metastasis < 10 mm in size

    Other protocol-defined Exclusion criteria apply
    Enfermedades:
    1.Melanoma uveal
    2.Signos en curso o recientes (en menos de 2 años) de una enfermedad autoinmunitaria que ha requerido tratamiento sistémico con agentes inmunosupresores. No son excluyentes: el vitíligo, el asma infantil que ha desaparecido, el hipotiroidismo residual que requiere solo reposición hormonal y la psoriasis que no requiere tratamiento sistémico.
    3.La infección no controlada por el virus de la inmunodeficiencia humana (VIH), la infección por el virus de la hepatitis B (VHB) o la hepatitis C (VHC), o el diagnóstico de inmunodeficiencia que está relacionada con una infección crónica o la provoca.
    4.Estado de mutación BRAF V600 desconocido.
    Tratamiento anterior o simultáneo:
    5.Supresión inmunitaria sistémica:
    a.Uso de dosis inmunosupresoras de corticoesteroides (>10 mg de prednisona al día o equivalente) en los 14 días posteriores a la primera dosis del medicamento del estudio. Se permiten dosis de reemplazo fisiológico de hasta 10 mg de prednisona/día o equivalente. Los esteroides inhalados o tópicos están permitidos, siempre que no sean para el tratamiento de un trastorno autoinmunitario.
    b.Otras formulaciones con importancia clínica de inmunosupresores sistémicos.
    6.Tratamiento con otras terapias contra el cáncer, incluidas la inmunoterapia, la quimioterapia, la radioterapia, intervenciones quirúrgicas mayores o tratamientos biológicos durante los 21 días anteriores a la primera dosis del tratamiento del ensayo. Se permite la hormonoterapia adyuvante utilizada para el cáncer de mama u otros cánceres sensibles a las hormonas en remisión a largo plazo.
    Otras enfermedades concomitantes:
    7.Antecedentes o signos actuales de infección local o sistémica significativa (grado CTCAE ≥2) (p. ej., celulitis, neumonía o septicemia) que requiera tratamiento antibiótico sistémico durante los 14 días anteriores a la primera dosis del medicamento del ensayo.
    8.Metástasis cerebrales activas o sin tratar, o compresión de la médula espinal. Se excluyen los pacientes con enfermedad leptomeníngea. Los pacientes con metástasis cerebrales conocidas son idóneos si:
    a.han recibido radioterapia u otra terapia estándar apropiada para las metástasis cerebrales,
    b.han vuelto a la situación neurológica inicial (excepto los signos y los síntomas residuales relacionados con el tratamiento del SNC) durante al menos 14 días antes de la inclusión,
    c.no han requerido dosis inmunosupresoras de terapia con corticoesteroides (>10 mg de prednisona al día o equivalente) durante los 14 días anteriores a la inscripción,
    d.son asintomáticos con una sola metástasis cerebral no tratada con un tamaño <10 mm.
    Se aplican otros criterios de exclusión definidos por el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    PFS (progression-free survival)
    SSP (supervivencia sin progresión)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 27 months
    Aproximadamente 27 meses
    E.5.2Secondary end point(s)
    1. Overall survival (OS)
    2. Objective response rate (ORR)
    3. Disease control rate (DCR)
    4. Duration of response (DoR)
    5. PFS
    6. Incidence of Adverse Events (AEs)
    7. Occurrence of interruption and discontinuation of study drug(s) due to AEs
    8. Incidence of deaths
    9. Incidence of laboratory abnormalities
    10. Concentrations of cemiplimab in serum
    11. Concentrations of fianlimab in serum
    12. Incidence and titer of anti-drug antibodies (ADA) to fianlimab over time
    13. Incidence and titer of ADA to cemiplimab over time
    14. Incidence of neutralizing antibodies (NAb) to fianlimab over time
    15. Incidence of NAb to cemiplimab over time
    16. Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
    17. PROs as measured by EQ-5D-5L
    18. PROs as measured by Functional Assessment of Cancer Therapy (FACT)-melanoma (melanoma subscale only)
    19. PROs as measured by Patient Global Impression of Severity (PGIS) 20. PROs as measured by Patient Global Impression of Change (PGIC) 21. Change in physical functioning per EORTC QLQ-C30
    22. Change in role functioning per EORTC QLQ-C30
    23. Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
    24. Change in physical functioning per EORTC QLQ-C30
    25. Change in role functioning per EORTC QLQ-C30
    26. Change in GHS/QoL per EORTC QLQ-C30
    1.Supervivencia general (SG)
    2.Tasa de respuesta objetiva (TRO)
    3.Tasa de control de la enfermedad (TCE)
    4.Duración de la respuesta (DR)
    5.SSP
    6.Incidencia de acontecimientos adversos (AA)
    7.Casos de interrupciones y suspensiones del medicamento o los medicamentos del estudio debido a AA
    8.Incidencia de muertes
    9.Incidencia de alteraciones analíticas
    10.Concentraciones séricas de cemiplimab
    11.Concentraciones séricas de fianlimab
    12.Incidencia y concentración de anticuerpos antifármaco (AAF) contra el fianlimab a lo largo del tiempo
    13.Incidencia y concentración de AAF contra el cemiplimab a lo largo del tiempo
    14.Incidencia de anticuerpos neutralizantes (AcN) al fianlimab a lo largo del tiempo
    15.Incidencia de AcN al cemiplimab a lo largo del tiempo
    16.Resultados percibidos por el paciente (RPP) evaluados mediante el Cuestionario C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer sobre la calidad de vida (EORTC QLQ-C30)
    17.RPP evaluados mediante el EQ-5D-5L
    18.RPP evaluados mediante la Evaluación funcional del tratamiento del cáncer
    (FACT)-melanoma (solo la subescala del melanoma)
    19.RPP evaluados mediante la Impresión global del paciente sobre la gravedad (PGIS)
    20.RPP evaluados mediante la Impresión global del paciente sobre el cambio (PGIC)
    21.Cambio en el funcionamiento físico según el EORTC QLQ-C30
    22.Cambio en el funcionamiento de rol según el EORTC QLQ-C30
    23.Cambio en el estado de salud global/calidad de vida (ESG/CV) según el EORTC QLQ-C30
    24.Cambio en el funcionamiento físico según el EORTC QLQ-C30
    25.Cambio en el funcionamiento de rol según el EORTC QLQ-C30
    26.Cambio en el ESG/CV según el EORTC QLQ-C30
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4: Up to 96 months
    2-5: Up to 27 months
    6-7: Up to 90 days post last dose, approximately 6 years
    8: Up to 6 years
    9-11: Up to 90 days post last dose, approximately 6 years
    12-15: Up to 30 days post last dose, approximately 6 years
    16-18: Up to 90 days post last dose, approximately 6 years
    19-20: Up to 21 days post last dose, approximately 6 years
    21-23: Baseline to Week 25
    24-26: Baseline to end of study, approximately 6 years
    1-4: hasta 96 meses
    2-5: hasta 27 meses
    6-7: hasta 90 días después de la última dosis, aproximadamente 6 años 8: hasta 6 años
    9-11: hasta 90 días después de la última dosis, aproximadamente 6 años
    12-15: hasta 30 días después de la última dosis, aproximadamente 6 años
    16-18: hasta 90 días después de la última dosis, aproximadamente 6 años
    19-20: hasta 21 días después de la última dosis, aproximadamente 6 años
    21-23: desde la visita inicial hasta la semana 25
    24-26: desde la visita inicial hasta el final del estudio, aproximadamente 6 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 Yes
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Incidence and titer of anti-drug antibodies (ADA) and incidence of neutralizing antibodies (NAb) to fianlimab and cemiplimab over time.
    Inmunogenicidad
    Incidencia y concentración de anticuerpos antifármaco (AAF) e incidencia de anticuerpos neutralizantes (AcN) contra el fianlimab y el cemiplimab a lo largo del tiempo
    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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pembrolizumab
    E.8.2.4Number of treatment arms in the trial3
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA106
    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
    Australia
    Brazil
    Canada
    Chile
    Georgia
    Mexico
    Russian Federation
    South Africa
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    France
    Germany
    Ireland
    Italy
    Poland
    United Kingdom
    Romania
    Spain
    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
    The end of study is defined as the date the last patient completes the last study visit withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator).
    El final del estudio se define como la fecha en que el último paciente complete la última visita del estudio, se retire del estudio o se pierda el contacto con él durante el seguimiento (es decir, el investigador ya no pueda contactar con el paciente del estudio).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 6
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 194
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under 18 years of age
    Sujetos menores de 18 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 544
    F.4.2.2In the whole clinical trial 1100
    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)
    none
    Ninguno
    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 Decision2022-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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