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    Summary
    EudraCT Number:2020-000245-13
    Sponsor's Protocol Code Number:SOLTI-1907
    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:2023-10-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-000245-13
    A.3Full title of the trial
    A Phase II with 2 parallel cohorts clinical trial targeting estrogen receptor negative or PAM50 non-luminal disease with Atezolizumab in combination with Trastuzumab and Vinorelbine in HER2-positive advanced/metastatic breast cancer – ATREZZO Study
    Ensayo clínico de fase II con dos cohortes paralelas en pacientes con receptores de estrógenos negativos o enfermedad no-luminal según PAM50, Tratamiento con atezolizumab en combinación con trastuzumab y vinorelbina en el cáncer de mama avanzado/metastásico HER2-positivo – Estudio ATREZZO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of atezolizumab in combination with Trastuzumab and Vinorelbine in HER2-positive advanced/metastatic breast cancer – ATREZZO Study
    Estudio clínico de tratamiento con atezolizumab en combinación con trastuzumab y vinorelbina en el cáncer de mama avanzado/metastásico HER2-positivo – Estudio ATREZZO
    A.3.2Name or abbreviated title of the trial where available
    ATREZZO
    ATREZZO
    A.4.1Sponsor's protocol code numberSOLTI-1907
    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 SponsorSOLTI
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRoche Farma, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOLTI
    B.5.2Functional name of contact pointAREA DE INVESTIGACION CLINICA
    B.5.3 Address:
    B.5.3.1Street AddressC/ BALMES 89 3-7
    B.5.3.2Town/ cityBARCLEONA
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.6E-mailregsolti@gruposolti.org
    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 Yes
    D.2.1.1.1Trade name TECENTRIQ
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nameATEZOLIZUMAB
    D.3.2Product code RO5541267
    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 INNATEZOLIZUMAB
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado de la inmunoglobulina G1(IgG1)FC
    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
    Pre- and post-menopausal women with locally advanced or metastatic HER2-positive breast cancer who have progressed to trastuzumab/pertuzumab and T-DM1.
    Mujeres pre y posmenopáusicas con cáncer de mama localmente avanzado o metastásico HER2-positivo que hayan progresado con trastuzumab/pertuzumab y T-DM1.
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast cancer
    Cancer de mama metastásico
    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 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of atezolizumab plus trastuzumab and vinorelbine treatment in unresectable locally advanced or metastatic ER-neg or non-luminal HER2+ PD-L1 positive breast cancer (Cohort 1)
    Evaluar la eficacia del tratamiento con atezolizumab más trastuzumab y vinorelbina en el cáncer de mama RE-neg o HER2+ PD-L1 positivo, no luminal, localmente avanzado irresecable o metastásico (cohorte 1).
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of atezolizumab plus trastuzumab and vinorelbine treatment in locally advanced or metastatic ER-neg or non-luminal HER2+ PD-L1 negative breast cancer (Cohort 2).
    - To determine the clinical benefit of Atezolizumab plus trastuzumab and vinorelbine in each cohort.
    - To assess the safety and tolerability of the combination
    - Evaluar la eficacia del tratamiento con atezolizumab más trastuzumab y vinorelbina en el cáncer de mama RE-neg o HER2+ PD-L1 negativo, no luminal, localmente avanzado o metastásico (cohorte 2).
    - Determinar el beneficio clínico de atezolizumab más trastuzumab y vinorelbina en cada cohorte.
    - Evaluar la seguridad y tolerabilidad de la combinación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written signed ICF.
    2. Male or female patients. Premenopausal or postmenopausal women.
    3. Age 18 years or older
    4. ECOG performance status 0 to 2
    5. Histologically confirmed adenocarcinoma of the breast, metastatic or unresectable locally advanced.
    a. Patients with standard curative options available will not be eligible.
    b. Invasive HER2-positive breast cancer in the last biopsy performed
    c. In patients with bilateral breast cancer, HER2+ positivity must be demonstrated in both sites or in the last metastatic biopsy.
    d. Hormone receptor negative according to the local laboratory in the last biopsy performed, OR Hormone receptor positive breast cancer in the last biopsy performed according to the local laboratory, AND centrally confirmed non-luminal intrinsic subtype as per PAM50 analysis (i.e. HER2-E or Basal-like).
    6. All patients must have received at least pertuzumab/trastuzumab and T-DM1 in one as follows situation:
    a. For patients with newly diagnosed HER2+ advanced disease or advanced disease that recurred after 6 months of last dose of adjuvant therapy, must have received at least 2 previous lines of systemic treatment for metastatic disease with trastuzumab/pertuzumab and T-DM1
    b. For patients who recur during or within 6 months after completing adjuvant therapy with trastuzumab +/- pertuzumab can be enrolled after one line of systemic treatment for metastatic disease with T-DM1.
    c. For patients who recur during or within 6 months after completing adjuvant treatment with T-DM1 and neoadjuvant therapy with trastuzumab and pertuzumab can be enrolled directly in the moment of the diagnosis of metastatic disease.
    d. Previous use of other anti-HER2 treatments, alone or in combination with chemotherapy, is permitted, including lapatinib, neratinib, trastuzumab, tucatinib, other anti-HER2 antibody drug conjugates or antiHER2 tyrosine-kinase inhibitors.
    e. Previous use of any hormone agent or chemotherapy (except Vinorelbine or any other vinca alkaloids) is permitted.
    a. Availability of formalin-fixed paraffin-embedded (FFPEThe tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for PD-L1 expression and PAM50 test (if HR positive) prior to enrolment. Patients whose tumor tissue is not evaluable for prospective central testing are not eligible.
    7. Measurable disease according to RECIST 1.1 criteria
    8. Adequate organ function,
    9. Baseline LVEF ≥50% measured using echocardiogram or equilibrium isotopic ventriculography (MUGA).
    10. Absence of psychological, family, sociological or geographical conditions that could potentially hinder compliance with the study protocol and follow-up schedule. These situations must be discussed with the patient before she is included in the study.
    11. If female of childbearing potential, must have a negative result of serum pregnancy test performed within 7 days prior to first dose of study treatment.
    12. Participants with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
    - Measurable disease outside the CNS is present.
    - No evidence of interim CNS progression between the completion of CNS-directed therapy and the screening radiographic study.
    - Metastases are limited solely to cerebellar and supratentorial lesions (i.e., no metastases to midbrain, pons, medulla, spinal cord, leptomeningeal metastases or carcinomatosis leptomeningeal)
    - No stable requirement for corticosteroids or anticonvulsants as therapy for CNS disease; anticonvulsants or low-dose of corticosteroids (≤ 10 mg oral prednisone or equivalent) at a stable dose during >2weeks are allowed.
    - No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to enrolment
    - No evidence of progression or hemorrhage after completion of CNS directed therapy.
    1. Consentimiento informado por escrito firmado
    2. Pacientes varones o mujeres. Mujeres premenopáusicas o posmenopáusicas.
    3. Mayor de 18
    4. ECOG de 0 a 2.
    5. Adenocarcinoma de mama confirmado histológicamente, metastásico o localmente avanzado e irresecable.
    a. Los pacientes con enfermedad localmente avanzada deben mostrar una enfermedad recurrente o progresiva, no susceptible de resección con intención curativa. No podrán participar pacientes que dispongan de opciones curativas convencionales.
    b. Cáncer de mama invasivo HER2 positivo en la última biopsia realizada, según el laboratorio local, definida según los criterios más recientes de la ASCO/CAP.
    c. En el caso de los pacientes con cáncer de mama bilateral, la positividad HER2+ se debe demostrar en ambas localizaciones o en la última biopsia metastásica.
    d. Cáncer de mama con receptor hormonal negativo según el laboratorio local en la última biopsia realizada, definido según los criterios más recientes de la ASCO/CAP, O BIEN con receptor hormonal positivo en la última biopsia realizada según el laboratorio local, definido según los criterios más recientes de la ASCO/CAP Y subtipo intrínseco no luminal confirmado centralmente según el análisis PAM50 (es decir, HER2-E o de tipo basal).
    6. Todos los pacientes deben haber recibido al menos pertuzumab/trastuzumab y T-DM1 en una de las situaciones siguientes:
    a. En los pacientes con enfermedad avanzada HER2+ recién diagnosticada o enfermedad avanzada que recidive después de 6 meses de la última dosis del tratamiento adyuvante, deben haber recibido al menos 2 líneas previas de tratamiento sistémico para la enfermedad metastásica con trastuzumab/pertuzumab y T-DM1
    b. Los pacientes que recidiven durante el tratamiento adyuvante con trastuzumab +/- pertuzumab o en los 6 meses siguientes a su finalización podrán participar después de una línea de tratamiento sistémico para la enfermedad metastásica con T-DM1.
    c. Los pacientes que recidiven durante el tratamiento adyuvante con T-DM1 o en los 6 meses siguientes a la finalización del mismo y el tratamiento neoadyuvante con trastuzumab y pertuzumab pueden incluirse directamente en el momento del diagnóstico de la enfermedad metastásica.
    d. Se permite el uso previo de otros tratamientos anti-HER2, solos o en combinación con quimioterapia, como lapatinib, neratinib, trastuzumab, tucatinib, otros conjugados fármaco-anticuerpo anti-HER2 o inhibidores de la tirosina-cinasa anti-HER2.
    e. Se permite el uso previo de cualquier fármaco hormonal o quimioterapia (excepto vinorelbina o cualquier otro alcaloide de la vinca).
    a. Disponibilidad de un bloque tumoral fijado en formol e incluido en parafina (FFIP) para análisis de biomarcadoresEl tejido tumoral debe ser de buena calidad basándose en el contenido tumoral total y viable, y deberá evaluarse de forma centralizada la expresión de PD-L1 y el análisis PAM50 (si es RH positivo) antes de la inclusión. No son elegibles los pacientes cuyo tejido tumoral no sea evaluable para el análisis central prospectivo.
    7. Enfermedad mensurable conforme a los criterios RECIST 1.1
    8. Función orgánica adecuada
    9. FEVI basal ≥ 50 % medida mediante ecocardiograma o ventriculografía isotópica en equilibrio (MUGA).
    10. Ausencia de condiciones psicológicas, familiares, sociológicas o geográficas que pudieran llegar a dificultar el cumplimiento del protocolo del estudio y el calendario de seguimiento. Estas situaciones deben comentarse con el paciente antes de su inclusión en el estudio.
    11. Las mujeres en edad fértil deberán dar negativo en una prueba de embarazo en suero realizada en los 7 días previos a la primera dosis del tratamiento del estudio.
    12. Podrán incorporarse participantes con antecedentes de metástasis tratadas del SNC siempre que cumplan todos los criterios siguientes:
    - Presencia de enfermedad mensurable fuera del SNC.
    - Ausencia de indicios de progresión intermedia en el SNC entre la finalización del tratamiento dirigido al SNC y el estudio radiológico de selección.
    - Las metástasis se limitan exclusivamente a lesiones cerebelosas y supratentoriales (ausencia de metástasis en mesencéfalo, protuberancia, bulbo raquídeo, médula espinal, metástasis leptomeníngeas o carcinomatosis leptomeníngea).
    - Ausencia de necesidad estable de corticosteroides o antiepilépticos como tratamiento de la afectación del SNC; se permiten los antiepilépticos o dosis bajas de corticosteroides (≤ 10 mg de prednisona oral o equivalente) en una dosis estable durante > 2 semanas.
    - Ausencia de radioterapia estereotáctica en los 7 días previos a la inclusión o de radioterapia holocraneal en los 14 días previos a la inclusión.
    - Ausencia de signos de progresión o hemorragia después de finalizar el tratamiento dirigido al SNC.
    E.4Principal exclusion criteria
    1. Treatment with any investigational anticancer drug within 14 days of the start of study treatment.
    2. Patient has received Vinorelbine or any other vinca alkaloids previously.
    3. History of other malignant tumors in the past 3 years, except for adequately treated in situ carcinoma of the cervix, non-melanoma carcinoma of the skin, uterine cancer in stage I or other malignant tumors with an expected curative outcome.
    4. Patients who have received radiation therapy for metastases outside the brain carried out in the 21 days prior to inclusion in the study and/or patients who have received radiation to > 30% of the bone marrow.
    5. Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 days prior to inclusion in the study. Bisphosphonates or RANKL inhibitor, will be permitted for the prevention of bone events.
    6. History of exposure to cumulative anthracycline doses greater than follows:
    a. Adriamycin > 400 mg/m2
    b. Epirubicin > 720 mg/m2
    c. Mitoxantrone > 120 mg/m2
    d. Idarubicin > 90 mg/m2
    e. If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 400 mg/m2 of adriamycin.
    7. Cardiopulmonary dysfunction
    8. Any other severe, uncontrolled disease (pulmonary, cardiac, metabolic, or hematological disorder, wound healing disorders, ulcers, bone fractures, infectious processes).
    9. Major surgery in the 28 days prior to enrolment or foreseeable during study treatment period.
    10. Infection with HIV or active Hepatitis B and/or Hepatitis C.
    11. History of trastuzumab intolerance, including grade 3-4 infusion reaction or hypersensitivity.
    12. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the atezolizumab formulation
    13. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barré syndrome, multiple sclerosis , vasculitis, or glomerulonephritis. (Note: Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.)
    14. Prior allogeneic stem cell or solid organ transplantation
    15. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. (Note: History of radiation pneumonitis in the radiation field [fibrosis] is permitted.)
    16. Active tuberculosis
    17. Receipt of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study.
    Note: Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 28 days prior to enrolment, during treatment or within 5 months following the last dose of atezolizumab
    18. Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents
    19. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to enrolment
    20. Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, cyclosporine, methotrexate, thalidomide, and antitumor necrosis factor [TNF] agents) within 2 weeks prior to enrolment, or anticipated requirement for systemic immunosuppressive medications during the trial.
    a. Patients who have received acute, low-dose (≤ 10 mg oral prednisone or equivalent), systemic immunosuppressant medications may be enrolled in the study.
    b. Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using MRI.
    c. The use of corticosteroids (≤ 10 mg oral prednisone or equivalent) for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low dose supplemental corticosteroids for adrenocortical insufficiency are allowed
    21. Inability, in the opinion of the investigator, to comply with the protocol requirements or any comorbidity that might hinder study follow-up, response evaluation or the informed consent process.
    1. Tratamiento con cualquier fármaco antineoplásico en investigación en los 14 días previos al comienzo del tratamiento del estudio.
    2. El paciente ha recibido vinorelbina o cualquier otro alcaloide de la vinca con anterioridad.
    3. Antecedentes de otros tumores malignos en los últimos 3 años, excepto carcinoma in situ de cuello uterino, carcinoma de piel distinto del melanoma, cáncer de útero en estadio I u otros tumores malignos debidamente tratados con el resultado curativo esperado.
    4. Pacientes que hayan recibido radioterapia por metástasis fuera del cerebro realizada en los 21 días previos a la inclusión en el estudio y/o pacientes que hayan recibido radioterapia en > 30 % de la médula ósea.
    5. Hipercalcemia sintomática que requiera tratamiento con bisfosfonatos en los 14 días previos a la inclusión en el estudio. Se permitirá el uso de bisfosfonatos o inhibidores de RANKL para la prevención de episodios óseos.
    6. Antecedentes de exposición a dosis acumuladas de antraciclinas superiores a las siguientes:
    a. Adriamicina > 400 mg/m2
    b. Epirubicina > 720 mg/m2
    c. Mitoxantrona > 120 mg/m2
    d. Idarubicina > 90 mg/m2
    e. Si se ha utilizado otra antraciclina, o más de una antraciclina, la dosis acumulada no debe ser superior al equivalente a 400 mg/m2 de adriamicina.
    7. Disfunción cardiopulmonar
    8. Cualquier otra enfermedad grave no controlada (trastorno pulmonar, cardíaco, metabólico o hematológico, trastornos de cicatrización de heridas, úlceras, fracturas óseas, procesos infecciosos).
    9. Intervención de cirugía mayor en los 28 días previos al reclutamiento o previsible durante el período de tratamiento del estudio.
    10. Infección por el VIH o infección activa por hepatitis B o C.
    11. Antecedentes de intolerancia a trastuzumab, incluida la reacción a la infusión de grado 3-4 o la hipersensibilidad.
    12. Hipersensibilidad o alergia conocida a biofármacos producidos en células ováricas de hámster chino (CHO) o a cualquiera de los componentes de la formulación de atezolizumab.
    13. Antecedentes de enfermedad autoinmunitaria, como miastenia grave, miositis, hepatitis autoinmunitaria, lupus eritematoso sistémico, artritis reumatoide, enfermedad inflamatoria intestinal, trombosis vascular asociada a síndrome antifosfolipídico, granulomatosis de Wegener, síndrome de Sjögren, síndrome de Guillain-Barré, esclerosis múltiple, vasculitis o glomerulonefritis. (Nota: podrán participar en este estudio pacientes con antecedentes de hipotiroidismo autoinmunitario tratados con una dosis estable de hormonas de reposición tiroidea y pacientes con diabetes mellitus de tipo 1 controlada tratados con una pauta estable de insulina.)
    14. Antecedentes de trasplante alogénico de células madre o de trasplante de órgano sólido.
    15. Antecedentes de fibrosis pulmonar idiopática (incluida neumonitis), neumonitis de origen medicamentoso, neumonía organizada (bronquiolitis obliterante, neumonía organizada criptógena) o signos de neumonitis activa en la TC de tórax realizada para la selección. (Nota: se admiten los antecedentes de neumonitis por radiación en el campo irradiado [fibrosis]).
    16. Tuberculosis activa.
    17. Recepción de una vacuna de virus vivos atenuados en las 4 semanas previas al reclutamiento o previsión de la necesidad de una vacuna de este tipo durante el estudio.
    Nota: los pacientes deben estar de acuerdo en no recibir una vacuna antigripal de virus vivos atenuados (p. ej., FluMist®) en los 28 días previos al reclutamiento, durante el tratamiento y en los 5 meses siguientes a la última dosis de atezolizumab.
    18. Tratamiento previo con agonistas de CD137, anticuerpos terapéuticos anti-PD-1 o anti-PD-L1 o fármacos dirigidos contra puntos de control inmunológico.
    19. Tratamiento con inmunoestimuladores sistémicos (por ejemplo, interferones o interleucina [IL]-2) en las 4 semanas previas o el equivalente a cinco semividas del fármaco (lo que sea más largo) previos a la inclusión.
    20. Tratamiento con inmunodepresores sistémicos (como, entre otros, corticosteroides, ciclofosfamida, azatioprina, ciclosporina, metotrexato, talidomida y agentes contra el factor de necrosis tumoral [TNF]) en las 2 semanas anteriores a la aleatorización, o previsión de que vayan a necesitarse inmunodepresores sistémicos durante el ensayo.
    a. En el estudio podrán participar pacientes que hayan recibido inmunodepresores sistémicos en dosis bajas y a corto plazo (≤ 10 mg de prednisona oral o equivalente).
    b. Los pacientes con antecedentes de reacción alérgica al contraste IV con necesidad de pretratamiento con esteroides deberán someterse a evaluaciones tumorales basales y posteriores mediante RM.
    c. Se permitirá el uso de corticoides (≤ 10 mg de prednisona oral o equivalente) por enfermedad pulmonar obstructiva crónica, de mineralocorticoides (por ejemplo, fludrocortisona) por hipotensión ortostática y de corticoides suplementarios en dosis bajas por insuficiencia corticosuprarrenal.
    21. Incapacidad.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response rate (ORR) defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
    Tasa de respuesta global (TRG), definida como la proporción de pacientes con una mejor respuesta global de respuesta completa (RC) o respuesta parcial (RP), según la evaluación del investigador local y conforme a los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1 .
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline until end of study
    Desde basal hasta final de estudio
    E.5.2Secondary end point(s)
    - Overall Response rate (ORR) defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
    - Clinical Benefit Rate at 24 weeks (CBR6) as defined by RECIST 1.1 (including patients with Complete response (CR), Partial response (PR), Stable Disease (SD) > 24 week)
    - Overall survival
    - Progression free survival
    - Duration of response
    - Time to response
    - AEs according to CTCAE v 5.0.
    - Tasa de respuesta global (TRG), definida como la proporción de pacientes con una mejor respuesta global de respuesta completa (RC) o respuesta parcial (RP), según la evaluación del investigador local y conforme a los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1
    - Tasa de beneficio clínico a las 24 semanas (TBC6) según lo definido por los criterios RECIST 1.1 (incluidos pacientes con respuesta completa (RC), respuesta parcial (RP) o enfermedad estable (EE) > 24 semanas).
    - Supervivencia global
    - Supervivencia sin progresión
    - Duración de la respuesta
    - Tiempo hasta la respuesta
    - AA según los CTCAE v 5.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline until end of study
    Desde basal hasta final de estudio
    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 No
    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) 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) 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 No
    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
    2 cohortes paralelas: PD-L1 positivo y PD-L1 negativo.
    2 parallel cohorts: PD-L1 positive and PD-L1 negative.
    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 concerned16
    E.8.5The trial involves multiple Member States No
    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 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
    Last Visit Last Subject (LVLS)
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    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
    No aplicable
    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 Decision2021-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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