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    Summary
    EudraCT Number:2017-002289-35
    Sponsor's Protocol Code Number:SGNLVA-002
    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:2018-02-02
    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 number2017-002289-35
    A.3Full title of the trial
    Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination with Pembrolizumab for First-Line Treatment of Patients with Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
    Estudio en fase Ib/II, abierto, con un solo grupo de SGN LIV1A en combinación con pembrolizumab para el tratamiento de primera línea de pacientes con cáncer de mama triple negativo irresecable, metastásico o localmente avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
    Seguridad y eficacia de SGN-LIV1A con Pembrolizumab en pacientes con cáncer de mama triple negativo irresecable, metastásico o localmente avanzado
    A.4.1Sponsor's protocol code numberSGNLVA-002
    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 SponsorSeattle Genetics, 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 supportSeattle Genetics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPRA Health Sciences
    B.5.2Functional name of contact pointMiguelle Doki-Thonon
    B.5.3 Address:
    B.5.3.1Street AddressTour So Ouest, 35 rue d’Alsace
    B.5.3.2Town/ cityLEVALLOIS-PERRET
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number+33141344424
    B.5.6E-maildokithononmiguelle@prahs.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 nameLadiratuzumab vedotin
    D.3.2Product code SGN-LIV1A
    D.3.4Pharmaceutical form Lyophilisate 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 INNladiratuzumab vedotin
    D.3.9.1CAS number 1629760-29-7
    D.3.9.2Current sponsor codeSGN-LIV1A
    D.3.9.3Other descriptive namevcMMAE-hLIV22 hLIV22-vcMMAE
    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: 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 namePembrolizumab
    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.3.9.2Current sponsor codeMK-3475 (Anti–PD-1)
    D.3.9.3Other descriptive nameHumanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the fragment crystallizable (Fc) region
    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.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
    Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
    Cáncer de mama triple negativo irresecable, metastásico o localmente avanzado
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cáncer de mama
    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 LLT
    E.1.2Classification code 10072740
    E.1.2Term Locally advanced breast 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 10075566
    E.1.2Term Triple negative breast 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 10027475
    E.1.2Term Metastatic breast 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ● Evaluate the safety and tolerability of the combination of SGN LIV1A and pembrolizumab in patients with locally-advanced or metastatic, triple-negative breast cancer (LA/M TNBC)
    ● Identify the recommended dose of SGN LIV1A in combination with pembrolizumab in patients with LA/M TNBC
    ● Evaluate confirmed objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of the combination of SGN LIV1A and pembrolizumab in patients with LA/M TNBC
    ● Evaluar la seguridad y la tolerabilidad de la combinación de SGN LIV1A y pembrolizumab en pacientes con cáncer de mama triple negativo localmente avanzado o metastásico (CMTN LA/M).
    ● Identificar la dosis recomendada de SGN LIV1A en combinación con pembrolizumab en pacientes con CMTN LA/M.
    ● Evaluar la tasa de respuesta objetiva (TRO) confirmada, según se determine mediante los criterios de evaluación de la respuesta en tumores sólidos (RECIST) v1.1, de la combinación de SGN LIV1A y pembrolizumab en pacientes con CMTN LA/M.
    E.2.2Secondary objectives of the trial
    ● Assess duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) as measured by RECIST v1.1
    ● Assess overall survival (OS)
    ● Evaluar la duración de la respuesta (DDR), la tasa de control de la enfermedad (TCE) y la supervivencia sin progresión (SSP), según se determinen mediante RECIST v1.1.
    ● Evaluar la supervivencia global (SG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
    2. Have not previously received therapy for the treatment of unresectable LA/M breast cancer.
    3. For patients previously treated with curative intent, at least 12 months must have elapsed between the completion of such treatment (e.g., date of primary breast tumor surgery or date of last adjuvant cytotoxic therapy administration, whichever occurred last) and first documented local or distant disease recurrence.
    4. Measureable disease per computed tomography (CT) scan as defined in RECIST v1.1: at least 1 tumor lesion ≥10 mm in the longest diameter, or a lymph node ≥15 mm in short axis measurement.
    5. Patients ≥18 years of age.
    6. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
    7. Able to provide fresh tissue for biomarker analysis from a newly obtained core or excisional biopsy of a tumor lesion.
    8. Meet baseline laboratory data criteria.
    9. For patients of childbearing potential as defined in Section 4.3, the following stipulations apply:
    a. Must have a negative serum or urine pregnancy test
    b. Must agree not to try to become pregnant from the time of enrollment until at least 6 months after the final dose of study drug.
    10. Patient must provide written informed consent.
    1. Cáncer de mama triple negativo (CMTN) metastásico o localmente avanzado, histológicamente documentado (ausencia de expresión de HER2, ER y PR).
    2. No haber recibido previamente terapia para el tratamiento del cáncer de mama LA/M irresecable.
    3. Para los pacientes tratados previamente con intención curativa, deben haber transcurrido al menos 12 meses entre la finalización de dicho tratamiento (p. ej., fecha de la cirugía del tumor de mama primario o fecha de la última administración de tratamiento citotóxico complementario, lo que ocurra más tarde) y la primera recidiva de la enfermedad local o distante documentada.
    4. Enfermedad medible mediante exploración por tomografía axial computarizada (TAC) según se define en los criterios RECIST v1.1: al menos 1 lesión tumoral ≥10 mm en el diámetro más largo o un ganglio linfático ≥15 mm en la medida del eje corto.
    5. Pacientes ≥18 años de edad.
    6. Puntuación del estado funcional del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG) de 0 o 1.
    7. Capaz de proporcionar tejido fresco para el análisis de biomarcadores a partir de una biopsia con aguja gruesa o por escisión recién obtenida de una lesión tumoral.
    8. Cumplir los criterios de datos analíticos iniciales.
    9. En las pacientes en edad fértil, según se define en la sección 4.3, se aplican las siguientes condiciones:
    a. Deben contar con una prueba de embarazo en suero o en orina negativa.
    b. Deben aceptar no intentar quedarse embarazadas desde el momento de la inclusión hasta al menos 6 meses después de la dosis final del fármaco del estudio.
    10. El paciente debe proporcionar el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Prior treatment with SGN LIV1A.
    2. Prior immuno-oncology therapy
    3. Pre-existing neuropathy of Grade ≥2.
    4. Radiographic evidence of central nervous system metastases.
    5. History of leptomeningeal carcinomatosis.
    6. Active infection requiring systemic treatment ≤7 days before dose of study drug.
    7. Known to be positive for hepatitis B by surface antigen expression, active hepatitis C infection or a known history of being seropositive for HIV.
    8. Active autoimmune disease that has required systemic treatment in past 2 years
    9. History of interstitial lung disease.
    10. Current pneumonitis, or history of (non-infectious, including radiation induced) pneumonitis that required steroids.
    14. Has a diagnosis of immunodeficiency or is receiving steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
    15. Patients who are breastfeeding.
    1. Tratamiento previo con SGN LIV1A.
    2. Tratamiento inmunooncológico previo.
    3. Neuropatía preexistente de grado ≥2.
    4. Pruebas radiográficas de metástasis en el sistema nervioso central.
    5. Antecedentes de carcinomatosis leptomeníngea.
    6. Infección activa que requiere tratamiento sistémico ≤7 días antes de la dosis del fármaco del estudio.
    7. Se sabe que es positivo para la hepatitis B por la expresión del antígeno superficial, tiene infección activa por hepatitis C o tiene antecedentes conocidos de seropositividad para VIH.
    8. Enfermedad autoinmune activa que haya requerido tratamiento sistémico en los últimos 2 años.
    9. Antecedentes de neumopatía intersticial.
    10. Neumonitis actual o antecedentes de neumonitis (no infecciosa, incluida la inducida por radiación) que requirió corticoesteroides.
    14. Presenta un diagnóstico de inmunodeficiencia o está recibiendo tratamiento con corticoesteroides (en dosis que exceden los 10 mg diarios de equivalente de prednisona) o cualquier otra forma de tratamiento inmunodepresor en los 7 días previos a la primera dosis del tratamiento del estudio.
    15. Pacientes en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    ● Type, incidence, severity, seriousness, and relatedness of AEs
    ● Laboratory abnormalities
    ● Incidence of dose-limiting toxicity (DLT)
    ● Confirmed ORR as determined by the investigator according to RECIST v1.1
    ● Tipo, incidencia, intensidad, gravedad y relación de los acontecimientos adversos (AA)
    ● Anomalías de laboratorio
    ● Incidencia de toxicidad limitante de dosis (TLD)
    ● TRO confirmada según lo determinado por el investigador, de acuerdo con los criterios RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety evaluation including AEs, laboratory abnormalities and incidence of DLT: in Part A, the safety of combination treatment will be evaluated by the SMC prior to expansion of enrollment to evaluate treatment effect in Part B. After 6 patients have been followed through the end of the DLT period, or at the point that 2 or more patients experience a DLT, whichever comes first.
    In Part B, the SMC will continue to evaluate and monitor the safety of study drug throughout the study. It will convene as needed.
    - For confirmed ORR: Patients will be evaluated for response after every 2 cycles of treatment in the first 8 cycles, and after every fourth cycle thereafter. If clinically indicated, response evaluation may be preformed earlier at the discretion of the investigator.
    Evaluación de seguridad,incluidos AA,anomalías de laboratorio e incidencia de TLD:en parte A,el comité de vigilancia de seguridad(CVS)evaluará seguridad del tratam. de combinación antes de expansión de la inclusión para evaluar el efecto del tratam. en parte B.Después de hacer seguimiento a 6 pacientes hasta fin del periodo de TLD o cuando 2 o más pacientes experimenten TLD,lo que ocurra antes
    En la parte B,el CVS seguira evaluando y controlando la seguridad del fármaco a lo largo del estudio.Este se reunirá cuando sea necesario
    -En caso de TRO confirmada:Se evaluará respuesta de pacientes cada 2 ciclos de tratam. durante los primeros 8 ciclos y cada cuatro ciclos a partir de entonces.Si está clínicamente indicado,se podrá realizar evaluación de respuesta antes,a criterio de investigador
    E.5.2Secondary end point(s)
    ● DOR as determined by RECIST v1.1
    ● DCR as determined by RECIST v1.1.
    ● PFS as determined by RECIST v1.1
    ● OS
    ● Duración de la respuesta (DR) según se determina mediante los criterios RECIST v1.1
    ● Tasa de control de la enfermedad (TCE) según se determina mediante los criterios RECIST v1.1
    ● Supervivencia sin progresión (SSP) según se determina mediante los criterios RECIST v1.1
    ● Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Response evaluation for confirmed DOR, DCR and PFS: Patients will be evaluated for response after every 2 cycles of treatment in the first 8 cycles, and after every fourth cycle thereafter. If clinically indicated, response evaluation may be preformed earlier at the discretion of the investigator.
    - OS status evaluation: All patients will be followed for survival until death or study closure, whichever occurs first. Patients will be followed every 12 weeks (±1 week).
    - Evaluación de la respuesta para DR, TCE y SSP confirmadas: Se evaluará la respuesta de los pacientes cada 2 ciclos de tratamiento durante los primeros 8 ciclos y después de cada cuatro ciclos a partir de entonces. Si está clínicamente indicado, se podrá realizar una evaluación de la respuesta antes, según el criterio del investigador.
    - Evaluación del estado de SG: Se realizará un seguimiento de la supervivencia a todos los pacientes hasta su fallecimiento o hasta el cierre del estudio, lo que suceda antes. Se realizará un seguimiento a los pacientes cada 12 semanas (±1 semana).
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Ib
    Fase Ib
    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 Yes
    E.8.1.7.1Other trial design description
    Brazo Unico
    Single-arm
    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 EEA20
    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
    France
    Germany
    Italy
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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 date the last patient met criteria for study discontinuation.
    La fecha en la que el ultimo paciente cumpla algun criterio apra ser discontinuado del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 72
    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)
    Not applicable.
    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 Decision2018-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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