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    Summary
    EudraCT Number:2019-001655-39
    Sponsor's Protocol Code Number:GCT1015-07
    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:2019-12-20
    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 number2019-001655-39
    A.3Full title of the trial
    A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin Versus Investigator’s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
    Ensayo en fase III, aleatorizado y abierto de tisotumab vedotina en comparación con la quimioterapia de elección del investigador como tratamiento de segunda o tercera línea del cáncer de cuello uterino recurrente o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMIZED, OPEN-LABEL TRIAL TO COMPARE TISOTUMAB VEDOTIN TO INVESTIGATOR'S CHOICE CHEMOTHERAPY IN PATIENTS WITH CERVICAL CANCER
    UN ENSAYO ALETATORIZADO, ABIERTO PARA COMPARAR EL TISOTUMAB VEDOTINA CON LA QUIMIOTERAPIA DE ELECCIÓN DEL INVESTIGADOR EN PACIENTES CON CÁNCER CERVICAL
    A.3.2Name or abbreviated title of the trial where available
    innovaTV 301
    A.4.1Sponsor's protocol code numberGCT1015-07
    A.5.4Other Identifiers
    Name:135476Number:IND
    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.5.6E-mailclinicaltrials@genmab.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 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 1418731-10-8
    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 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 Gemcitabine 1000 mg, powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSun Pharmaceutical Industries Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 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 Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSeacross Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.4EV Substance CodeSUB08295MIG
    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.IMP: 4
    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 Potactasol (Topotecan Actavis)4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 INNTOPOTECAN
    D.3.9.1CAS number 123948-87-8
    D.3.9.4EV Substance CodeSUB11191MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 5
    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 Vinorelbin Aurobindo 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderPUREN Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 INNVINORELBINE
    D.3.9.1CAS number 71486-22-1
    D.3.9.4EV Substance CodeSUB00069MIG
    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.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
    Second- or Third-Line Recurrent or Metastatic Cervical Cancer
    Cáncer de cuello uterino de segunda o tercera línea
    E.1.1.1Medical condition in easily understood language
    Second- or Third-Line Cervical Cancer
    Cáncer de cuello uterino de segunda o tercera línea
    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
    •To demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in subjects with second- or third-line (2L-3L) cervical cancer
    •Demostrar la mejoría en la eficacia clínica de tisotumab vedotina comparado con la quimioterapia en sujetos con cáncer de cuello uterino de segunda o tercera línea (2L-3L)
    E.2.2Secondary objectives of the trial
    •To further demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in subjects with 2L-3L cervical cancer
    •To demonstrate improvement in antitumor activity of tisotumab vedotin compared to chemotherapy in subjects with 2L-3L cervical cancer
    •To evaluate the safety and tolerability of tisotumab vedotin
    •To assess health-related quality of life (HRQOL)
    •Demostrar aún más la mejoría en la eficacia clínica de tisotumab vedotina comparado con la quimioterapia en sujetos con cáncer de cuello uterino de 2L-3L
    •Demostrar la mejoría en la actividad antitumoral de tisotumab vedotina comparado con la quimioterapia en sujetos con cáncer de cuello uterino de 2L-3L
    •Evaluar la seguridad y la tolerabilidad de tisotumab vedotina
    •Evaluar la calidad de vida relacionada con la salud (CdVRS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥18 years (for subjects in Japan, age ≥20 years).
    2.Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial prior to any other trial-related assessments or procedures.
    3.Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:
    a.Has experienced disease progression during or after treatment with standard of care systemic therapy defined as either:
    - paclitaxel+cisplatin+bevacizumab, or
    - paclitaxel+carboplatin+bevacizumab, or
    - paclitaxel+topotecan/nogitecan+bevacizumab
    b.Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer.
    c.Is not a candidate for curative therapy, including but not limited to radiotherapy or exenterative surgery.
    5.Acceptable renal function
    6.Acceptable liver function
    7.Acceptable hematological status
    8.Has ECOG PS of 0 or 1 prior to randomization.
    10.Has a negative serum pregnancy test for female subjects of reproductive potential. Subjects that are postmenopausal or permanently sterilized (refer to Section 10.1.4) can be considered as not having reproductive potential.
    11.Subjects of reproductive potential must agree to use adequate contraception during and for 6 months after the last trial treatment administration.
    13.Where required by local health authorities, has negative serology for hepatitis B surface antigen (HBsAg)/HBV DNA, or hepatitis C antibody (HCVAb) or RNA. Active hepatitis C is defined by a known positive HCVAb result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
    14.Must provide a fresh or archival biopsy prior to the first planned administration of trial treatment, unless determined it is unfeasible after sponsor medical review.
    1. Edad ≥18 años (para las sujetos en Japón, edad ≥20 años).
    2. Debe firmar un formulario de consentimiento informado (FCI) en el que indique que entiende la finalidad y los procedimientos necesarios para el ensayo y que está dispuesta a participar en el ensayo antes de que tenga lugar cualquier otra evaluación o procedimiento relacionado con el ensayo.
    3. Padece cáncer de cuello uterino recurrente o metastásico con histología epidermoide, de adenocarcinoma o de carcinoma adenoescamoso y:
    a. Ha experimentado progresión de la enfermedad durante o después del tratamiento sistémico de la práctica clínica habitual, que se define como:
    - paclitaxel + cisplatino + bevacizumab o
    - paclitaxel + carboplatino + bevacizumab o
    - paclitaxel + topotecán/nogitecán + bevacizumab.
    b. Ha recibido 1 o 2 pautas posológicas previas de tratamiento sistémico para el cáncer de cuello uterino recurrente y/o metastásico.
    c. No es candidata para un tratamiento curativo, incluidos, entre otros, la radioterapia o la cirugía resectiva.
    5. Función renal aceptable.
    6. Función hepática aceptable.
    7. Estado hematológico aceptable.
    8. Presenta un EG ECOG de 0 o 1 antes de la aleatorización.
    10. Presenta un resultado negativo en la prueba de embarazo en suero para las mujeres en edad fértil. Se puede considerar que las sujetos que son posmenopáusicas o que se hayan esterilizado de manera permanente (consulte la sección 10.1.4) no se encuentran en edad fértil.
    11. Las sujetos en edad fértil deben aceptar el uso de métodos anticonceptivos adecuados durante la administración del tratamiento del ensayo y hasta 6 meses después de su última administración.
    13. Presenta una serología negativa para el antígeno de superficie del virus la hepatitis B (HBsAg)/ADN del VHB o del anticuerpo contra el virus de la hepatitis C (HCVAb) o ARN del VHC, cuando así lo exijan las autoridades sanitarias locales. La hepatitis C activa se define mediante un resultado positivo conocido para el HCVAb y resultados del ARN del VHC cuantitativos conocidos superiores a los límites inferiores de la detección de la prueba.
    14. Debe proporcionar una biopsia en fresco o de archivo antes de la primera administración programada del tratamiento del ensayo, a menos que tras la revisión médica del promotor se determine que es inviable.
    E.4Principal exclusion criteria
    1.Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned in inclusion criterion 3
    2.Has clinically significant bleeding issues or risks
    3. Clinically significant cardiac disease
    5.Ocular surface disease Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or above, any prior episode of cicatricial conjunctivitis, or any prior episode of Stevens-Johnson syndrome.
    6.Other cancer: known past or current malignancy other than inclusion diagnosis, except for: non-invasive basal cell or squamous cell skin carcinoma; non-invasive, superficial bladder cancer; any curable cancer with a complete response (CR) of ≥5 years duration.
    8.Surgery/procedures: major surgery within 4 weeks or minor surgery within 7 days prior to the first trial treatment administration. Subjects must have recovered adequately from the toxicity or complications from the intervention prior to starting trial treatment. Subjects who have planned major surgery during the treatment period must be excluded from the trial.
    9.Peripheral neuropathy ≥grade 2.
    10.Prior anti-cancer therapy:
    a.Any prior treatment with MMAE-derived drugs.
    b.Radiotherapy within 21 days prior to the first administration of trial treatment. Subjects must have recovered from all clinically significant radiation-related toxicities. At least 42 days must have elapsed from the last administration of chemo radiotherapy.
    c.Is currently participating in or has participated in a trial of an investigational agent or device and received active treatment within 28 days prior to the first dose of trial treatment.
    1. Presenta una histología primaria neuroendocrina, linfocítica, sarcomatoide u otras histologías no mencionadas en el criterio de inclusión 3.
    2. Presenta riesgos o problemas hemorrágicos clínicamente significativos.
    3. Cardiopatía clínicamente significativa.
    5. Enfermedad de la superficie ocular de grado 2 o superior según los Criterios terminológicos comunes para acontecimientos adversos (CTCAE), cualquier episodio previo de conjuntivitis cicatricial o cualquier episodio previo de síndrome de Stevens-Johnson.
    6. Otros tipos de cáncer: neoplasia maligna conocida previa o actual distinta del diagnóstico de inclusión, excepto: carcinoma epidermoide o basocelular no invasivo; cáncer de vejiga superficial no invasivo; cualquier cáncer curable con una respuesta completa (RC) de ≥5 años de duración.
    8. Cirugía/operaciones: cirugía mayor en las 4 semanas o cirugía menor en los 7 días anteriores a la primera administración del tratamiento del ensayo. Las sujetos deben haberse recuperado de manera adecuada de la toxicidad o las complicaciones de la intervención antes de comenzar el tratamiento del ensayo. Se debe excluir del ensayo a las sujetos que tengan programada una cirugía mayor durante el período de tratamiento.
    9. Neuropatía periférica de grado ≥2.
    10. Tratamiento antineoplásico previo:
    a. Cualquier tratamiento previo con fármacos derivados de MMAE.
    b. Radioterapia en los 21 días previos a la primera administración del tratamiento del ensayo. Las sujetos deben haberse recuperado de todas las toxicidades clínicamente significativas relacionadas con la radiación. Deben haber transcurrido al menos 42 días desde la última administración de la quimio o radioterapia.
    c. Está participando o ha participado en un ensayo de un fármaco o producto en investigación y ha recibido tratamiento activo en los 28 días previos a la primera dosis del tratamiento del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    •Overall survival (OS)
    •Supervivencia general (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the trial, see protocol
    Durante el ensayo, vease el protocolo
    E.5.2Secondary end point(s)
    •Progression-free survival (PFS) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as assessed by the investigator
    •Confirmed overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator
    •Incidence of adverse events (AEs)
    •EQ-5D-3L index
    •EQ-5D visual analog scale (VAS)
    •EORTC-QLQ-C30
    •EORTC-QLQ-CX24
    •Supervivencia sin progresión (SSP) basada en los Criterios de evaluación de la respuesta en tumores sólidos (RECIST) v1.1 evaluados por el investigador
    •Tasa de respuesta global confirmada (TRG) basada en RECIST v1.1 evaluada por el investigador
    •Índice EQ-5D-3L
    •Escala visual analógica (VAS) EQ-5D
    •EORTC-QLQ-C30
    •EORTC-QLQ-CX24
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the trial, see protocol
    Durante el ensayo, vease el 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Imunogenicidad
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Investigators choice chemotherapy
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Austria
    Belgium
    Brazil
    Canada
    Croatia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Greece
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Netherlands
    Norway
    Singapore
    Spain
    Sweden
    Taiwan
    Ukraine
    United Kingdom
    United States
    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 when the last survival follow-up visit is completed or 5 years after randomization of the last subject participating in the trial, whichever occurs first.
    El ensayo se considera completado cuando se completa la última visita de seguimiento de supervivencia o 5 años después de la aleatorización del último sujeto que participó en el ensayo, lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    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 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: 386
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 96
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 482
    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
    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 Decision2021-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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