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    Summary
    EudraCT Number:2021-005392-39
    Sponsor's Protocol Code Number:213357
    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:2021-12-22
    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 number2021-005392-39
    A.3Full title of the trial
    OPAL Master Protocol:
    A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of Treatments in Participants with Ovarian Cancer (OPAL).
    Cohort C: Open-label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants with Homologous Recombination-Deficient Stage III/IV Ovarian Cancer.
    OPAL Protocolo Maestro:
    Estudio en paraguas de múltiples cohortes en fase IB/II para evaluar la seguridad y la eficacia de nuevos tratamientos y/o combinaciones de tratamientos en participantes con cáncer de ovario (OPAL).
    Cohorte C: Estudio de fase II, abierto, aleatorizado, controlado y multicéntrico para comparar niraparib frente a quimioterapia doble con platino-taxano como tratamiento neoadyuvante en participantes con cáncer de ovario en estadio III/IV con deficiencia de recombinación homóloga.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPAL Master Protocol
    Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of Treatments in Participants with Ovarian Cancer (OPAL).
    OPAL-Supplement C
    Cohort C: Open-Label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants with Homologous Recombination-Deficient Stage III/IV Ovarian Cancer.
    Estudio en paraguas de múltiples cohortes en fase IB/II para evaluar la seguridad y la eficacia de nuevos tratamientos y/o combinaciones de tratamientos en participantes con cáncer de ovario (OPAL).
    Cohorte C: Estudio de fase II, abierto, aleatorizado, controlado y multicéntrico para comparar niraparib frente a quimioterapia doble con platino-taxano como tratamiento neoadyuvante en participantes con cáncer de ovario en estadio III/IV con deficiencia de recombinación homóloga.
    A.4.1Sponsor's protocol code number213357
    A.5.4Other Identifiers
    Name:Protocol Number: PR-3000-02-005Number:Study Number: 213357
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithkline R&D Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 902202700
    B.5.5Fax number+34 918070479
    B.5.6E-mailes-ci@gsk.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 Yes
    D.2.1.1.1Trade name Zejula
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline (Ireland)
    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 nameNiraparib
    D.3.2Product code GSK3985771
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNniraparib
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeGSK3985771
    D.3.9.3Other descriptive nameNIRAPARIB TOSILATE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB183938
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Ovarian cancer
    Cáncer de ovario
    E.1.1.1Medical condition in easily understood language
    Ovarian Cancer
    Cáncer de ovario
    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 10033128
    E.1.2Term Ovarian 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 24.0
    E.1.2Level PT
    E.1.2Classification code 10084789
    E.1.2Term Homologous recombination deficiency positive advanced ovarian 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
    To evaluate the efficacy of neoadjuvant niraparib compared with neoadjuvant platinum-taxane doublet chemotherapy after 1 induction cycle of
    carboplatin-paclitaxel per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in participants with confirmed HRd Stage III to IV OC
    Evaluar la eficacia de niraparib neoadyuvante en comparación con quimioterapia doble neoadyuvante conun taxano-platino después de un ciclo de inducción con carboplatino-paclitaxel conforme a los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1, en participantes con cáncer deovario (CO) en estadio III a IV con deficiencia de recombinación homóloga (HRd) confirmada
    E.2.2Secondary objectives of the trial
    • To evaluate clinical benefit by Gynecological Cancer InterGroup (GCIG) cancer antigen 125 (CA-125) response criteria
    • To evaluate clinical benefit as measured by progression-free survival (PFS) per RECIST v1.1 by investigator assessment
    • To evaluate participants’ reported overall tolerability toward treatment, overall health status, OC-specific health-related quality of life (HRQoL) & symptoms, and work productivity
    • To evaluate clinical benefit as measured by OS
    • To evaluate clinical benefit as measured by time to first subsequent treatment (TFST)
    • To evaluate the safety and tolerability of neoadjuvant niraparib and neoadjuvant platinum-taxane doublet chemotherapy
    - Evaluar el beneficio clínico según los criterios de respuesta del antígeno 125 del cáncer (CA-125) delGynecological Cancer InterGroup (GCIG)
    - Evaluar el beneficio clínico, determinado mediante la supervivencia sin progresión (SSP) conforme alos criterios RECIST v1.1 según la evaluación del investigador.
    - Evaluar la tolerabilidad global comunicada por las participantes con respecto al tratamiento, el estadogeneral de salud, la calidad de vida relacionada con la salud (CVRS) y los síntomas específicos delCO, y la productividad laboral
    - Evaluar el beneficio clínico medido mediante la supervivencia global (SG).
    - Evaluar el beneficio clínico medido mediante el tiempo hasta el primer tratamiento posterior (TPTP).
    - Evaluar la seguridad y la tolerabilidad de niraparib y la quimioterapia doble neoadyuvante conplatino-taxano
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    C1. Participant must be female ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
    C2. Participant must have measurable disease according to RECIST v1.1.
    C3. Participant has an ECOG performance status of 0 to 2.
    C4. Participant has adequate organ function, defined as follows:
    a. Absolute neutrophil count ≥1500/μL, without growth factor support (granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administration is not permitted within 2 weeks of Screening)
    b. Platelets ≥100,000/μL without platelet transfusion support within 2 weeks prior to Screening
    c. Hemoglobin ≥9 g/dL without transfusion or growth factor (recombinant erythropoietin) within 2 weeks of Screening
    d. Serum creatinine ≤1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥50 mL/min using Cockcroft-Gault equation
    e. Total bilirubin ≤1.5× ULN, except in participants with Gilbert’s syndrome. Participants with Gilbert’s syndrome may enroll if direct bilirubin is ≤1.5× ULN.
    f. Aspartate aminotransferase and alanine aminotransferase ≤2.5× ULN, unless liver metastases are present, in which case they must be ≤5× ULN
    g. International normalized ratio or prothrombin time (PT) ≤1.5× ULN, unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
    h. Activated PTT ≤1.5× ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. Participants with known lupus anticoagulant and elevated PTT may be eligible on a case-by-case basis after discussion with the sponsor’s Medical Monitor.
    C5. Participant is not pregnant or breastfeeding, and at least 1 of the following conditions apply:
    - Is not a woman of childbearing potential (WOCBP), as defined in Appendix 1 in the master protocol.
    OR
    - Is a WOCBP using a contraceptive method that is highly effective (with a failure rate of <1% per year) with low user dependency, as described in Appendix 1 in the master protocol, during the treatment periods and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of study treatment.
    o A WOCBP must have a negative pregnancy test (highly sensitive urine test or serum test as required by local regulations) within 72 hours before the first dose of study treatment.
    If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    C6. Participant has newly diagnosed Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.
    C7. Participant must provide sufficient tumor tissue at Prescreening and agree to undergo a central HRD tumor testing using a fully validated assay. The tumor must be HRd as per central HRD tumor testing. If central testing does not confirm tumor HRd, the participant will not be eligible for the study.
    a. Participants with documented germline BRCA1/2 deleterious or suspected deleterious mutations by approved test (e.g., BRACAnalysis CDx) will be eligible but will require central HRD testing. Participants with local, academic, or university-based germline BRCA1/2 testing will not be allowed to enroll without results of central HRD test.
    b. All participants must agree to provide tumor tissue collected from IDS.
    c. Participant must provide 2 formalin-fixed paraffin-embedded tissue blocks (or slides if blocks are not available) with sufficient tumor content (as confirmed by the sponsor’s designated central and/or testing laboratory) for central HRD testing at Prescreening and for exploratory biomarker testing at Prescreening or Screening. If sufficient tumor tissue is provided at Prescreening, participants do not need to provide additional tissue at Screening.
    C8. Participant must have completed 1 run-in cycle of carboplatin-paclitaxel and not experienced disease progression after this treatment. Completion is defined as receiving ≥50% of the prescribed dose of therapy within 5 weeks.
    C9. Participant must not have known contraindication or uncontrolled hypersensitivity to carboplatin and paclitaxel and their excipients and no known pre-existing conditions that would preclude treatment with these agents.
    C10. Participant must not have known contraindication or uncontrolled hypersensitivity to niraparib and its excipients.
    C1. La participante debe ser una mujer ≥ 18 años, capaz de comprender los procedimientos del estudio y que acepte participar en el estudio otorgando su consentimiento informado por escrito.
    C2. La participante debe presentar enfermedad medible conforme a los criterios RECIST v1.1
    C3. La participante tiene una puntuación de estado funcional del ECOG de 0 o 2
    C4. La participante tiene una función orgánica adecuada, definida de la siguiente manera
    a. Recuento absoluto de neutrófilos ≥1500/μL, sin apoyo de factores de crecimiento (no se permite la administración del factor estimulante de colonias de granulocitos o del factor estimulante de colonias de granulocitos-macrófagos dentro de las 2 semanas de la Selección)
    b. Plaquetas ≥100.000/μL sin apoyo de transfusión de plaquetas dentro de las 2 semanas anteriores a la selección
    c. Hemoglobina ≥9 g/dL sin transfusión ni factor de crecimiento (eritropoyetina recombinante) en las 2 semanas anteriores a la selección
    d. Creatinina sérica ≤1,5× límite superior de la normalidad o aclaramiento de creatinina calculado ≥50 mL/min mediante la ecuación de Cockcroft-Gault
    e. Bilirrubina total ≤1,5× límite superior de la normalidad, excepto en los participantes con síndrome de Gilbert. Los participantes con síndrome de Gilbert pueden participar si la bilirrubina directa es ≤1,5× ULN.
    f. Aspartato aminotransferasa y alanina aminotransferasa ≤2,5× límite superior de la normalidad, a menos que haya metástasis hepáticas, en cuyo caso deben ser ≤5× límite superior de la normalidad
    g. Cociente internacional normalizado o tiempo de protrombina (TP) ≤1,5× límite superior de la normalidad, a menos que el participante esté recibiendo un tratamiento anticoagulante, siempre que el TP o el tiempo de tromboplastina parcial (TTP) estén dentro del rango terapéutico del uso previsto de los anticoagulantes
    h. TTP activado ≤1,5× límite superior de la normalidad, a menos que el participante esté recibiendo una terapia anticoagulante, siempre que el TP o el TTP estén dentro del rango terapéutico del uso previsto de los anticoagulantes. Los participantes con anticoagulante lúpico conocido y TTP elevado pueden ser elegibles según cada caso, después de discutirlo con el monitor médico de estudio.
    C5. La participante no está embarazada ni en período de lactancia, y se da al menos una de las siguientes condiciones:
    - No es una mujer en edad fértil, como se define en el Apéndice 1 del protocolo maestro.
    O
    - Es una mujer en edad fértil que utiliza un método anticonceptivo de alta eficacia (con una tasa de fracaso de <1% por año) con baja dependencia del usuario, como se describe en el Apéndice 1 en el protocolo maestro, durante los períodos de tratamiento y durante al menos 180 días después de la última dosis del tratamiento del estudio y se compromete a no donar óvulos (óvulos, oocitos) con fines de reproducción durante este período. El investigador debe evaluar la eficacia del método anticonceptivo en relación con la primera dosis del tratamiento del estudio.
    Una mujer en edad fértil debe tener una prueba de embarazo negativa (prueba de orina de alta sensibilidad o prueba de suero según lo requieran las regulaciones locales) dentro de las 72 horas anteriores a la primera dosis del tratamiento del estudio.
    Si una prueba de orina no puede confirmarse como negativa (por ejemplo, un resultado ambiguo), se requiere una prueba de embarazo en suero. En estos casos, la participante debe ser excluida de la participación si el resultado del embarazo en suero es positivo.
    C6. El participante tiene un cáncer de ovario, de trompa de Falopio o peritoneal primario de reciente diagnóstico en estadio III o IV según los criterios de estadificación de la Federación Internacional de Ginecología y Obstetricia.
    C7. La participante debe proporcionar suficiente tejido tumoral en la preselección y aceptar que se realice una prueba tumoral de DRH utilizando un laboratorio central con un ensayo totalmente validado. El tumor debe ser DRH según la prueba central de tumores DRH. Si la prueba central no confirma la DRH del tumor, la participante no será elegible para el estudio.
    a. Los participantes con mutaciones deletéreas o presuntas mutaciones deletéreas en la línea germinal de BRCA1/2 mediante una prueba aprobada (por ejemplo, BRACAnalysis CDx) serán elegibles, pero requerirán una prueba central de DRH. Los participantes con pruebas de línea germinal BRCA1/2 locales, académicas o universitarias no podrán participar sin los resultados de la prueba central DRH
    b. Todas las participantes deben estar de acuerdo en proporcionar tejido tumoral recogido en la cirugía.

    Ver Protocolo para una lista completa de los Criterios
    E.4Principal exclusion criteria
    C1. Participant has not recovered (i.e., to Grade ≤1 or to Baseline) from prior chemotherapy induced AEs. Note: Participant with Grade ≤2 neuropathy or alopecia is an exception to this criterion and may qualify for the study.
    C2. Participant has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy exceeding an equivalent of prednisone 10 mg daily or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
    C3. Participant is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment.
    C4. Participant has received prior systemic anticancer therapy including cytotoxic chemotherapy, PARP inhibitor, immune checkpoint inhibitors, hormonal therapy given with the intention to treat cancer, or biological therapy within 3 weeks of the first dose of study treatment. This washout period is required to ensure prior therapy is not confounding the toxicity profile of the investigational study drug or study drug combinations in cohorts.
    Note: For this cohort (Cohort C), this criterion will not apply because the population will include only participants who are eligible for neoadjuvant chemotherapy.
    C5. Participant has received live vaccine within 14 days of planned start of study therapy.
    C7. Participant had major surgery within 4 weeks of starting the study or participant has not recovered from any effects of any major surgery.
    C8. Participant has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation of ORR by RECIST v1.1 criteria. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer that is considered to be low risk for progression by the investigator.
    C9. Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. These include, but are not limited to, coronavirus disease 2019, significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, myocardial infarction, cardiac arrhythmia or unstable angina within 6 months prior to enrollment, New York Heart Association Grade ≥2 congestive heart failure, uncontrolled hypertension, serious cardiac arrhythmia requiring medication, Grade ≥2 peripheral vascular disease, and history of cerebrovascular accident within 6 months prior to enrollment), uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, and any psychiatric disorder that prohibits obtaining informed consent.
    C10. Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, might interfere with the participant’s participation for the full duration of the study treatment, or is not in the best interest of the participant to participate.
    C11. Participant has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative] is detected).
    C12. Participant has low-grade or Grade 1 epithelial OC or mucinous, germ cell, transitional cell, carcinosarcoma, or undifferentiated tumor.
    C13. Participant has contraindications to surgery.
    C14. Participant has a bowel obstruction by clinical symptoms or CT scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
    C15. Participant has any known history or current diagnosis of MDS or AML.
    C16. Participant is at increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to the start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
    C18. Participant received prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., prior surgery, immunotherapy, anticancer therapy [with the exception of 1 run-in cycle of carboplatin-paclitaxel], or radiation therapy).
    C19. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone or insulin).
    C20. Participant is unable to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication.
    C1. La participante no se ha recuperado (hasta un grado ≤ 1 o la situación basal) de acontecimientos adversos (AA) previos producidos por la quimioterapia. Nota: Pacientes con neuropatía o alopecia de grado ≤ 2 son una excepción a este criterio y podrán participar en el estudio.
    C2. La participante tiene un diagnóstico conocido de inmunodeficiencia o está recibiendo tratamiento con esteroides sistémicos que superen un equivalente de prednisona de 10 mg al día o cualquier otra forma de tratamiento inmunodepresor en los 7 días previos a la primera dosis del tratamiento del estudio.
    C3. La paciente está participando actualmente en un estudio de tratamiento o ha participado en un estudio de un fármaco en investigación en las 4 semanas previas a la primera dosis del tratamiento.
    C4. La paciente ha recibido tratamiento antineoplásico sistémico previo, como quimioterapia citotóxica, inhibidor de la PARP, inhibidores de puntos de control inmunitarios, hormonoterapia administrada con la intención de tratar el cáncer primario o tratamiento biológico en las 3 semanas previas a la primera dosis del tratamiento del estudio. Este período de lavado es necesario para garantizar que el tratamiento previo no confunda el perfil de toxicidad del fármaco del estudio ni las combinaciones de fármacos del estudio en investigación en cohortes.
    Nota: Para esta cohorte (Cohorte C), este criterio no se aplicará porque la población incluirá sólo a los participantes elegibles para quimioterapia neoadyuvante.
    C5. La participante ha recibido una vacuna viva en los 14 días anteriores al inicio previsto del tratamiento del estudio.
    C7. La participante ha sido sometido a una cirugía mayor dentro de las 4 semanas previas al inicio del estudio o el participante no se ha recuperado de los efectos de alguna cirugía mayor.
    C8. La participante tiene un tumor maligno adicional conocido que haya progresado o haya requerido tratamiento activo en los últimos 2 años, ya que la reaparición de otro tumor maligno podría confundir la interpretación de la Respuesta global según los criterios RECIST v1.1. Las excepciones incluyen el carcinoma de células basales de la piel, el carcinoma de células escamosas de la piel que ha sido sometido a una terapia potencialmente curativa, o el cáncer in situ que se considera de bajo riesgo de progresión por el investigador.
    C9. La participante se considera de alto riesgo médico debido a un trastorno médico grave e incontrolado, una enfermedad sistémica no maligna o una infección activa e incontrolada. Estas incluyen, pero no se limitan a, enfermedad por coronavirus 2019, enfermedad cardiovascular significativa (por ejemplo anomalías cardiacas significativas, infarto de miocardio, arritmia cardíaca o angina inestable en los 6 meses anteriores a la inclusión en el estudio, insuficiencia cardíaca congestiva de grado ≥2 de la New York Heart Association, hipertensión no controlada, arritmia cardíaca grave que requiera medicación, Enfermedad vascular periférica de grado ≥2 y antecedentes de accidente cerebrovascular en los 6 meses anteriores a la inclusión en el estudio), trastorno convulsivo grave no controlado, compresión inestable de la médula espinal, síndrome de vena cava superior y cualquier trastorno psiquiátrico que impida obtener el consentimiento informado.
    C10. La participante tiene antecedentes o evidencia actual de cualquier condición, terapia o anormalidad de laboratorio que pueda confundir los resultados del estudio, que pueda interferir con la participación en el estudio durante toda la duración del tratamiento, o que su participación no sea en el mejor interés del participante.
    C11. La participante tiene hepatitis B activa conocida (por ejemplo, antígeno de superficie de la hepatitis B reactivo) o hepatitis C (por ejemplo, se detecta ácido ribonucleico [cualitativo] del virus de la hepatitis C).
    C12. La participante tiene un tumor epitelial OC o mucinoso de bajo grado o de grado 1, de células germinales, de células de transición, carcinosarcoma o tumor indiferenciado.
    C13. La participante tiene contraindicaciones para la cirugía.
    C14. La participante tiene una obstrucción intestinal por síntomas clínicos o por TC, enfermedad mesentérica suboclusiva, fístula abdominal o gastrointestinal, perforación gastrointestinal o absceso intraabdominal.
    C15. La participante tiene antecedentes conocidos o un diagnóstico actual de SMD o LMA.
    C16. La participante tiene un mayor riesgo de hemorragia debido a condiciones concurrentes (por ejemplo, lesiones importantes o cirugía mayor en los últimos 28 días antes del inicio del tratamiento del estudio y/o antecedentes de accidente cerebrovascular hemorrágico, ataque isquémico transitorio, hemorragia subaracnoidea o hemorragia clínicamente significativa en los últimos 3 meses).

    Ver Protocolo para una lista completa de los Criterios
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy analysis is pre-IDS overall response rate (ORR; defined as the percentage of participants with unconfirmed complete or partial response) per RECIST v1.1 by investigator assessment.
    El análisis principal de la eficacia es la tasa de respuesta globales (TRG; definida como el porcentaje de participantes con respuesta completa o parcial no confirmada) antes de la CCI conforme a los criterios RECIST v1.1 según la evaluación del investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q3 2024
    Q3 2024
    E.5.2Secondary end point(s)
    Secondary endpoints include CA-125 progression by GCIG CA-125 response criteria; PFS; patient-reported outcomes to evaluate overall tolerability to treatment, overall health status, OC-specific health-related quality of life and symptoms, and work productivity; OS; TFST; and safety and tolerability
    Los criterios de valoración secundarios son la progresión del CA-125 según los criterios de respuesta del CA-125 del GCIG; la SSP; los resultados comunicados por las pacientes para evaluar la tolerabilidad global al tratamiento, el estado general de salud, la calidad de vida y los síntomas relacionados con la salud específicos del CO, y la productividad laboral; la SG; el TPTP; y la seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Q1 2026
    Q1 2026
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Canada
    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
    LVLS
    LSLV
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 74
    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 No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 28
    F.4.2.2In the whole clinical trial 84
    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
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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