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    Summary
    EudraCT Number:2016-002799-28
    Sponsor's Protocol Code Number:TG4001.12
    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:2019-07-09
    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 number2016-002799-28
    A.3Full title of the trial
    A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies and expansion cohort to oropharyngeal squamous cell carcinoma of the head and neck (SCCHN)
    Ensayo de fase Ib/II que evalúa la combinación de TG4001 y avelumab en pacientes con tumores malignos recurrentes o metastásicos positivos para VPH-16 y cohorte de expansión a carcinoma de células escamosas de cabeza y cuello (CCECC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of TG4001 and avelumab cancer immunotherapies in advanced HPV-induced malignancies
    Estudio de TG4001 y avelumab como inmunoterapia contra el cáncer en tumores malignos avanzados inducidos por HPV
    A.4.1Sponsor's protocol code numberTG4001.12
    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 SponsorTransgene
    B.1.3.4CountryFrance
    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 supportTransgene
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportMerck
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTransgene
    B.5.2Functional name of contact pointMedical Affairs Secretariat
    B.5.3 Address:
    B.5.3.1Street Address400 boulevard Gonthier d’Andernach - Parc d'innovation - CS80166
    B.5.3.2Town/ cityIllkirch-Graffenstaden Cedex
    B.5.3.3Post code67405
    B.5.3.4CountryFrance
    B.5.4Telephone number+33388279155
    B.5.5Fax number+33388279141
    B.5.6E-mailclinical.trials@transgene.fr
    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 nameMVA-HPV-IL2
    D.3.2Product code TG4001
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTipapkinogene sovacivec
    D.3.9.2Current sponsor codeMVATG8042
    D.3.9.3Other descriptive nameMVATG8042
    D.3.9.4EV Substance CodeSUB185094
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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 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 nameAvelumab
    D.3.2Product code MSB0010718C
    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 INNAvelumab
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.4EV Substance CodeSUB180078
    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 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.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
    HPV-16 positive recurrent or metastatic malignancies including oropharyngeal squamous cell carcinoma of head and neck, cervical cancer, vulvar cancer, vaginal cancer, penile cancer, anal cancer
    Neoplasias malignas recurrentes o metastásicas positivas para VPH-16 que incluyen carcinoma de células escamosas de cabeza y cuello, cáncer cervical, cáncer vulvar, cáncer de vagina, cáncer de pene, cáncer anal
    E.1.1.1Medical condition in easily understood language
    Any cancer induced by the HPV-16 virus.
    Cualquier cáncer inducido por el virus VPH-16
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061424
    E.1.2Term Anal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10034299
    E.1.2Term Penile cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046888
    E.1.2Term Vaginal cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047777
    E.1.2Term Vulvar cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib objective: To evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies.

    Phase II objective: To evaluate the efficacy of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in the expansion cohort of oropharyngeal recurrent or metastatic squamous cell carcinoma of head and neck.
    Fase Ib: Evaluar la seguridad y la tolerabilidad de la combinación de TG4001 más avelumab en pacientes con neoplasias malignas avanzadas recurrentes o metastásicas positivas para el VPH-16.

    Fase II: Evaluar la eficacia de la combinación de TG4001 con avelumab en cuanto a la tasa de respuesta general (TRG) mediante el uso de los criterios RECIST 1.1 en la cohorte de expansión del CCECC recurrente o metastásico.
    E.2.2Secondary objectives of the trial
    To evaluate the combination of TG4001 and avelumab with respect to:
    • Overall response rate (ORR) by using RECIST 1.1 (phase Ib part)
    • Progression Free Survival (PFS)
    • Overall Survival (OS)
    • Duration of Response (DoR)
    • Disease control rate (DCR)
    • Safety profile (phase II part)
    Evaluar la combinación de TG4001 y avelumab con respecto a:
    • Tasa de respuesta global (TRG) usando los criterios RECIST 1.1 (parte de la fase Ib)
    • Supervivencia libre de progresión (SLP)
    • Supervivencia global (SG)
    • Duración de la respuesta (DR)
    • Tasa de control de la enfermedad (TCE)
    • Perfil de seguridad (parte de la fase II)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent.
    • Female or male patients, aged at least 18 years (no upper limit of age)
    • ECOG PS 0 or 1
    • Life expectancy of at least 3 months
    • Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer. Phase Ib: cervical, vulvar, vaginal, penile, anal, and oropharyngeal squamous cell carcinoma of head and neck. Phase II part: an expansion cohort of oropharyngeal SCCHN will be included
    • Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression
    • Prior therapy: Patients MAY have received up to 2 prior lines of systemic chemotherapy for the management of metastatic or recurrent disease; for SCCHN, patients MUST have previously been exposed to platinum-based therapy, either as part of definitive chemo-radiation OR as first line systemic treatment for metastatic disease which may include cetuximab. Patients with recurrence/progression within 6 months of prior multimodal therapy using platinum-based therapy are eligible. Patients with cervical cancer may have undergone surgery and/or received definitive radiation or chemo-radiation therapy for localized disease.
    • Availability of tumor tissue from biopsy
    • At least one measurable lesion by CT scan according to RECIST 1.1.
    • Adequate hematological, hepatic and renal function
    • Negative blood pregnancy test at screening for women of childbearing potential
    • Highly effective contraception for both male and female patients if the risk of conception exists during the study period and for 3 months after the last study treatment administration
    1. Consentimiento informado firmado por escrito
    2. Pacientes de ambos sexos, mayores de 18 años (sin límite de edad)
    3. Estado funcional de ECOG 0 o 1
    4. Esperanza de vida de al menos 3 meses
    5. Pacientes con cáncer VPH-16+ metastásico o resistente al tratamiento/recurrente documentado histológica o citológicamente. Fase Ib: cervical, vulvar, vaginal, peneano, anal y carcinoma de células escamosas de cabeza y cuello (CCECC). Fase II: se incluirá una cohorte de expansión de CCECC
    6. La enfermedad NO DEBE ser susceptible de resección quirúrgica curativa o radioterapia curativa con progresión de la enfermedad documentada
    7. Tratamiento previo:
    - Los pacientes PUEDEN haber recibido hasta dos líneas previas de quimioterapia sistémica para el tratamiento de la enfermedad metastásica o recurrente; para el CCECC, los pacientes DEBEN haber estado expuestos previamente a una terapia basada en platino, ya sea como parte de la quimiorradiación definitiva O como tratamiento sistémico de primera línea para la enfermedad metastásica que puede incluir cetuximab. Los pacientes con recidiva/progresión dentro de los 6 meses de la terapia multimodal anterior que utilizaba terapia basada en platino son elegibles. Las pacientes con cáncer de cuello uterino pueden haberse sometido a cirugía y/o haber recibido radioterapia o quimiorradioterapia definitiva para la enfermedad localizada.
    8. Disponibilidad de tejido tumoral de una biopsia
    9. Al menos una lesión mensurable por TAC de acuerdo con los criterios RECIST 1.1
    10. Función hematológica, hepática y renal adecuadas
    11. Prueba de embarazo en sangre negativa en la selección para mujeres en edad fértil
    12. Método anticonceptivo altamente eficaz tanto para hombres como mujeres si existe el riesgo de concepción durante el período del ensayo y durante 3 meses después de la última administración del tratamiento del ensayo
    E.4Principal exclusion criteria
    • Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
    • Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed
    • Patients with CNS metastases except those with brain metastases treated locally and clinically stable during 4 weeks prior to start of study treatment, and those without ongoing neurological symptoms that are related to the brain localization of the disease
    • Other active malignancy requiring concurrent systemic intervention
    • Patients with previous malignancies other than the target malignancy to be investigated in this trial (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
    • Patients with any organ transplantation, including allogeneic stem cell transplantation
    • Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC V4.03), any history of anaphylaxis, or uncontrolled asthma
    • Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products
    • Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients
    • Patients with history of interstitial lung disease
    • Patients with active, known, or suspected auto-immune disease or immunodeficiency, except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment
    • Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication/active intervention
    • History of uncontrolled intercurrent illness including but not limited to:
    - Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower)
    - Uncontrolled diabetes (e.g., hemoglobin A1c ≥ 8%)
    1. Exposición previa a inmunoterapia contra el cáncer, incluyendo vacunas contra el cáncer, cualquier anticuerpo o fármaco dirigido a proteínas co-reguladoras de células T (puntos de control inmunitarios).
    2. Pacientes en tratamiento crónico con corticosteroides sistémicos u otros fármacos inmunosupresores durante un período de al menos 4 semanas y cuyo tratamiento no se interrumpió 2 semanas antes del primer tratamiento del ensayo, con la excepción de los pacientes con insuficiencia suprarrenal que pueden continuar con corticosteroides en dosis de sustitución fisiológica, equivalentes a ≤ 10 mg de prednisona al día. Se permiten los esteroides sin efecto sistémico o con un efecto mínimo (tópico, por inhalación)
    3. Pacientes con metástasis en el sistema nervioso central (SNC), excepto aquellos con metástasis cerebrales que han sido tratadas localmente y son clínicamente estables durante las 4 semanas previas al inicio del tratamiento del ensayo; y aquellos sin síntomas neurológicos permanentes que estén relacionados con la localización cerebral de la enfermedad .
    4. Otras neoplasias malignas activas que requieren intervención sistémica simultánea.
    5. Pacientes con neoplasias malignas previas distintas de la neoplasia objetivo que se investigará en este ensayo (excepto los cánceres de piel no melanoma y los siguientes cánceres localizados: vejiga, gástrico, de colon, endometrial, cervical/displasia, melanoma o de mama) a menos que se logre una remisión completa por lo menos 2 años antes de la entrada en el ensayo Y no se requiera ningún tratamiento adicional durante el período de ensayo
    6. Pacientes con algún trasplante de órganos, incluido el alotrasplante de células madre
    7. Reacciones conocidas de hipersensibilidad grave a anticuerpos monoclonales (Grado ≥ 3 NCI-CTC V4.03), cualquier antecedente de anafilaxia o asma no controlado
    8. Cualquier alergia o reacción conocida a los huevos, gentamicina o atribuida a compuestos de composición química o biológica similar a las vacunas terapéuticas/productos inmunoterapéuticos
    9. Cualquier alergia o reacción conocida a algún componente del anti-PD-L1/PD-1 o sus excipientes
    10. Pacientes con historia de enfermedad pulmonar intersticial
    11. Pacientes con enfermedad autoinmune o inmunodeficiencia activa, conocida o sospechada, excepto diabetes mellitus de tipo I, hipotiroidismo que solo requiere sustitución hormonal o trastornos cutáneos (como vitíligo, psoriasis) que no requieren tratamiento sistémico
    12. Enfermedad cardiovascular clínicamente significativa (es decir, activa): accidente cerebrovascular/apoplejía o infarto de miocardio (< 6 meses antes de la inscripción), angina de pecho inestable, insuficiencia cardíaca congestiva (clase ≥ II según la New York Heart Association) o arritmia cardíaca grave no controlada que requiera medicación/intervención activa
    13. Antecedentes de enfermedad intercurrente no controlada, que incluye, entre otras:
    - Hipertensión no controlada con los tratamientos habituales (no estabilizada a 150/90 mmHg o menos)
    - Diabetes no controlada (por ejemplo, hemoglobina A1c ≥ 8 %)
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib: safety and tolerability
    Phase II: overall response rate according to RECIST 1.1
    Fase Ib: seguridad y tolerabilidad
    Fase II: tasa de respuesta general (TRG) de acuerdo a RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase Ib:
    - The safety data will be collected and evaluated by the Investigators and the sponsor on an ongoing basis.
    - Dose limiting toxicity will be assessed in each included and treated patient during the first 4 weeks.
    - A SRC will meet before each new cohort begins to analyse and review the safety data of all patients in the previous cohort.
    - At the end of the phase Ib, the safety data of all patients will be analyzed and discussed with the SRC which will make recommendation to the sponsor on the conduct of the study.
    Phase II: Tumor response will be evaluated at baseline and then every 6 weeks until disease progression. Beyond 9 months after start of treatment, tumor evaluation will be performed every 12 weeks until disease progression.
    Fase Ib:
    - Los datos de seguridad recopilarán y evaluarán de manera continua.
    - La toxicidad limitante de la dosis se evaluará en cada paciente incluido y tratado durante las primeras 4 semanas.
    - Un Comité Independiente de Seguimiento de Datos (CISD) se reunirá antes de que cada nueva cohorte comience para analizar y revisar los datos de seguridad de la cohorte anterior.
    - Al final de la fase Ib, los datos de seguridad se analizarán por el CISD, que hará recomendaciones al promotor sobre la realización del estudio.

    Fase II: la respuesta del tumor se evaluará al inicio y luego cada 6 semanas hasta la progresión de la enfermedad. Más allá de los 9 meses después del inicio del tratamiento, la evaluación del tumor se realizará cada 12 semanas hasta que la enfermedad progrese.
    E.5.2Secondary end point(s)
    Phase Ib: Overall response rate by using RECIST 1.1 and overall safety profile

    Phase II:
    - Progression Free Survival (PFS)
    - Overall Survival (OS)
    - Duration of Response (DoR)
    - Disease control rate (DCR)
    - Overall safety profile
    Fase Ib: Tasa de respuesta global (TRG) usando los criterios RECIST 1.1 y perfil de seguridad

    Fase II:
    • Supervivencia libre de progresión (SLP)
    • Supervivencia global (SG)
    • Duración de la respuesta (DR)
    • Tasa de control de la enfermedad (TCE)
    • Perfil de seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    In both phase of the study, tumor assessment will be performed locally according to investigator’s assessment every 6 weeks from the start of study treatment until disease progression or for a period of 9 months after start of study treatment, whichever occurs first. Beyond 9 months after start of study treatment, the evaluations will be performed every 12 weeks until disease progression. The overall safety profile will be assessed during the conduct of the trial.
    En ambas fases del estudio, la evaluación del tumor se realizará localmente según la evaluación del investigador, cada 6 semanas desde el inicio del tratamiento del estudio hasta la progresión de la enfermedad o durante un período de 9 meses después del inicio del tratamiento del estudio, lo que ocurra primero. Más allá de los 9 meses después del inicio del tratamiento, la evaluación del tumor se realizará cada 12 semanas hasta que la enfermedad progrese. El perfil de seguridad general se evaluará durante la realización del ensayo.
    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 No
    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) 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
    Both IMPs have already been administered to humans individually.
    Ambos medicamentos en investigación han sido administrados en humanos de forma individual.
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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 Decision2019-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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