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    Summary
    EudraCT Number:2017-004758-40
    Sponsor's Protocol Code Number:GCT1015-05/ENGOT-cx8
    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:2022-04-05
    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 number2017-004758-40
    A.3Full title of the trial
    A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer
    Ensayo Abierto en Fase Ib/II con Tisotumab Vedotina (HuMax®-TF-ADC) en Monoterapia y en Combinación con Otros Agentes en Sujetos con Cáncer Cervicouterino Recurrente o en Estadio IVB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) monotherapy and in combination in recurrent or Stage IVB cervical cancer
    Seguridad y eficacia de tisotumab vedotina (HuMax®-TF-ADC) en monoterapia y en combinación con otros agentes en sujetos con cáncer cervicouterino
    A.4.1Sponsor's protocol code numberGCT1015-05/ENGOT-cx8
    A.5.4Other Identifiers
    Name:INDNumber:135476
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post code1560
    B.5.3.4CountryDenmark
    B.5.4Telephone number+34934893000
    B.5.6E-mailaoaknin@vhio.net
    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 nameTisotumab vedotin
    D.3.2Product code HuMax®-TF-ADC
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNtisotumab vedotin
    D.3.9.1CAS number 1418731-10-1
    D.3.9.2Current sponsor codeIgG1-1015-011-1006
    D.3.9.3Other descriptive nameHUMAX-TF-ADC
    D.3.9.4EV Substance CodeSUB127266
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibody Drug Conjugate (ADC)
    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 Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 namePembrolizumab
    D.3.4Pharmaceutical form Concentrate for 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.3.9.3Other descriptive nameKeytruda
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    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 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.2.5The 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 nameCarboplatin
    D.3.4Pharmaceutical form Concentrate for 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 INNCarboplatin
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 4
    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.2.5The 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 namebevacizumab
    D.3.4Pharmaceutical form Concentrate for 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeBevacizumab is a recombinant humanised monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent or stage IVB cervical cancer
    Cáncer cervicouterino recurrente o metastásico
    E.1.1.1Medical condition in easily understood language
    Cervical cancer
    Cáncer cervicouterino
    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 10008342
    E.1.2Term Cervix carcinoma
    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
    Dose escalation: To establish the maximum tolerated dose(MTD) and RP2D of tisotumab vedotin in combination in subjects with advanced cervical cancer
    Dose expansion: Evaluate the antitumor activity of tisotumab vedotin monotherapy and in combination in subjects with cervical cancer
    Aumento gradual de la dosis: Establecer la dosis máxima tolerada (DMT) y la dosis recomendada para la fase II (DRF2) de tisotumab vedotina en combinación en sujetos con cáncer cervicouterino en estadio avanzado
    Expansión de la dosis: Evaluar la actividad antitumoral de tisotumab vedotina en monoterapia y en combinación en sujetos con cáncer cervicouterino
    E.2.2Secondary objectives of the trial
    Escalation: Assess safety and tolerability of tisotumab in combination (comb); Evaluate (eval) antitumor activity; Evaluate durability of response of tisotumab in comb;Eval clinical efficacy with tisotumab in comb; To eval the PK and immunogenicity of tisotumab in comb
    Exploratory: Explore relationship between biomarkers and clinical response; Assess potential PD biomarkers
    Expansion: Assess safety and tolerability of tisotumab monotherapy and in comb; Eval durability of response of tisotumab monotherapy and in comb; Eval clinical efficacy with tisotumab monotherapy and in comb; Evalthe PK and immunogenicity of tisotumab monotherapy and in comb
    Exploratory: Explore relationship between biomarkers and clinical response; Assess potential PD biomarkers; Eval the antitumor activity of tisotumab vedotin in comb with pembrolizumab in subjects with advanced cervical cancer (Arms E, F and H)
    Aumento gradual: Evaluar (eval) la seguridad y tolerabilidad de tisotumab vedotina (tis ved) en combinación (comb); Eval la actividad antitumoral; Eval la durabilidad de la respuesta a tis ved en comb;Eval la eficacia clínica con tis ved en comb;Eval la farmacocinética (FC) y la inmunogenia de tis ved en comb
    Exploratorios: Explorar la relación entre los biomarcadores y la respuesta clínica; Eval posibles biomarcadores farmacodinámicos
    Expansión: Eval la seguridad y tolerabilidad de tis ved en monoterapia (mon) y en comb; Eval la durabilidad de la respuesta a tis ved en mon y en comb;Eval la eficacia clínica con tis ved en mon y en comb;Eval la FC y la inmunogenia de tis ved en mono y en comb.
    Exploratorios: Explorar la relación entre los biomarcadores y la respuesta clínica; Eval posibles biomarcadores farmacodinámicos; Eval la actividad antitumoral de tis ved en comb con pembrolizumab en participantes con cáncer cervicouterino avanzado (grupos E, F y H)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after SOC treatments or are ineligible or intolerant to SOC for recurrent or stage IVB cervical cancer. (Arms A, B, and C only).
    Criterion revised per Amendment 6
    Criterion revised per Amendment 7
    - Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E and H).
    - Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than 2 prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and Arm G only).
    - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    - Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration. A WOCBP must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration (all arms).
    - Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).
    - Debe tener un carcinoma cervicouterino epidermoide o adenoescamoso o un adenocarcinoma cervicouterino y haber progresado durante o después de los tratamientos de referencia o ser intolerantes o no aptas para los tratamientos de referencia para el cáncer cervicouterino recurrente o en estadio IVB (grupos A, B y C);
    Criterio revisado por la Enmienda 6
    Criterio revisado por la Enmienda 7
    - Debe tener un carcinoma cervicouterino epidermoide o adenoescamoso o un adenocarcinoma cervicouterino y no haber recibido tratamiento sistémico previo para el cáncer cervicouterino recurrente o en estadio IVB (grupos D, E y H);
    - Debe tener un carcinoma cervicouterino epidermoide o adenoescamoso o un adenocarcinoma cervicouterino y haber progresado durante o después de al menos uno pero no más de 2 tratamientos sistémicos previos para el cáncer cervicouterino recurrente o en estadio IVB (grupos F y G);
    - Tener un estado general de 0 o 1 según la escala del Grupo Oncológico Cooperativo de la Costa Este de los EE. UU. (ECOG)
    - No estar embarazada, amamantando o esperando concebir hijos dentro de la duración prevista del ensayo y durante al menos 6 meses después de la última administración del tratamiento del ensayo. Una mujer potencialmente fértil debe aceptar usar un método anticonceptivo adecuado durante el ensayo y durante los 6 meses posteriores a la administración de la última dosis del tratamiento de prueba (todos los brazos).
    - Debe firmar un formulario de consentimiento informado (ICF) que indique que el sujeto del ensayo comprende el propósito y los procedimientos requeridos para el ensayo y está dispuesto a participar en el ensayo (All Arms).
    E.4Principal exclusion criteria
    - Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)
    - Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)
    - Criterion revised per Amendment 6
    - Criterion revised per Amendment 7
    - Has clinically significant bleeding issues or risks
    - Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arms A and H)
    - Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arm A and bevacizumab-eligible subjects in Arm H)
    - Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arm A and
    bevacizumab-eligible subjects in Arm H)
    Criterion revised per Amendment 6
    - Tiene hidronefrosis bilateral clínicamente significativa que no puede aliviarse con endoprótesis ureterales o con drenaje percutáneo
    - Tiene signos o síntomas clínicos de obstrucción gastrointestinal y requiere hidratación o nutrición parenteral. Se permiten las obstrucciones posoperatorias en las 4 semanas previas a la intervención quirúrgica abdominal
    - Criterio revisado por la Enmienda 6
    - Criterio revisado por Enmienda 7
    - Tiene riesgos o problemas hemorrágicos clínicamente significativos
    - Tiene antecedentes (3 meses) o indicios actuales de cualquier hemoptisis (2.5 mL o más) (Grupos A y H)
    - Sangrado gastrointestinal o vaginal clínicamente significativo reciente (dentro de las 4 semanas posteriores a la primera dosis del tratamiento de prueba) que requiere transfusión de PRBC (grupo A y sujetos elegibles para bevacizumab en el grupo H)
    - Evidencia reciente (dentro de las 4 semanas de la primera dosis del tratamiento de prueba) de
    complicaciones en la cicatrización de heridas que requieren intervención médica (Brazo A y sujetos elegibles para bevacizumab en el Grupo H)
    Criterio revisado por la Enmienda 6
    E.5 End points
    E.5.1Primary end point(s)
    Dose escalation: AEs, SAEs, infusion-related AEs, CTCAE grade ≥ 3 AEs, and AEs related to trial treatment during the trial
    Dose expansion: The primary endpoint is ORR per RECIST v1.1.
    Aumento de la dosis: EA, EAG, EA relacionados con la infusión, EA de grado CTCAE ≥ 3 y EA relacionados con el tratamiento del ensayo durante el ensayo
    Expansión de dosis: el objetivo principal es TRO según RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • During the trial, see protocol
    • Durante el ensayo, ver protocolo
    E.5.2Secondary end point(s)
    • AEs and evaluation of safety laboratory parameters.
    • Objective Response Rate (ORR) per RECIST v1.1 (only dose escalation)
    • DOR per RECIST v1.1.
    • TTR per RECIST v1.1.
    • PFS per RECIST v1.1.
    • Overall Survival (OS)
    • PK-concentrations and anti-drug antibodies (ADAs) associated with tisotumab vedotin in combination.
    • EA y evaluación de parámetros de laboratorio de seguridad.
    • Tasa de respuesta objetiva (TRO) según RECIST v1.1 (solo aumento de dosis)
    • DOR según RECIST v1.1.
    • TTR según RECIST v1.1.
    • PFS según RECIST v1.1.
    • Supervivencia general (SG)
    • Concentraciones farmacocinéticas y anticuerpos antidrogas (ADA) asociados con tisotumab vedotina en combinación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • During the trial, see protocol
    • Durante el ensayo, ver protocolo
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b (dose escalation - dose expansion)
    Fase 1b (aumento de dosis - expansión de dosis)
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial7
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Turkey
    United States
    Belgium
    Czechia
    Denmark
    Germany
    Ireland
    Italy
    United Kingdom
    Netherlands
    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 trial is considered completed four years after the last subject is enrolled
    El ensayo se considera completado cuatro años después de que se inscriba el último sujeto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 205
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 193
    F.4.2.2In the whole clinical trial 270
    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)
    Provided in the protocol
    Proporcionado en el protocolo
    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 Decision2022-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
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