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    Summary
    EudraCT Number:2019-003583-40
    Sponsor's Protocol Code Number:MS200647_0017
    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:2020-05-07
    Trial results View 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 number2019-003583-40
    A.3Full title of the trial
    A Phase II, Multicenter, Open Label Study of Bintrafusp alfa (M7824) Monotherapy in
    Participants with Advanced, Unresectable Cervical Cancer with Disease Progression During or After Platinum-Containing Chemotherapy
    Estudio en fase II, multicéntrico, abierto de bintrafusp alfa (M7824) en monoterapia en participantes con cáncer de cuello uterino avanzado no resecable con progresión de la enfermedad durante o después de la quimioterapia con platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Bintrafusp alfa Monotherapy in Platinum-Experienced Cervical Cancer
    Fase II de Bintrafusp alfa en monoterapia en cáncer de cuello uterino tratado previamente con platino
    A.3.2Name or abbreviated title of the trial where available
    Phase II Bintrafusp alfa Monotherapy in Platinum-Experienced Cervical Cancer
    Fase II de Bintrafusp alfa en monoterapia en cáncer de cuello uterino tratado previamente con platin
    A.4.1Sponsor's protocol code numberMS200647_0017
    A.5.4Other Identifiers
    Name:IND numberNumber:145485
    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 SponsorMerck Healthcare KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+3493 489 4350
    B.5.6E-mailservice@merckgroup.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 namebintrafusp alfa
    D.3.2Product code M7824
    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 INNbintrafusp alfa
    D.3.9.2Current sponsor codeM7824
    D.3.9.3Other descriptive nameMSB0011359C
    D.3.9.4EV Substance CodeSUB179957
    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 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
    Cervical Cancer
    Cáncer de cuello uterino
    E.1.1.1Medical condition in easily understood language
    Cervical Cancer
    Cáncer de cuello uterino
    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 LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical 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 clinical efficacy of bintrafusp alfa based on ORR
    - Evaluar la eficacia clínica de bintrafusp alfa, en función de la TRO
    E.2.2Secondary objectives of the trial
    -To evaluate clinical efficacy of bintrafusp alfa based on DOR
    -To evaluate clinical efficacy of bintrafusp alfa based on DRR
    -To evaluate clinical safety of bintrafusp alfa
    -To evaluate clinical efficacy based on PFS
    -To evaluate ORR, DOR, DRR, and PFS by Investigator read
    - To evaluate clinical efficacy based on OS
    - To characterize the PK profile of bintrafusp alfa
    - To characterize the immunogenicity of bintrafusp alfa
    - To evaluate clinical efficacy of bintrafusp alfa according to PD-L1 expression
    - Evaluar la eficacia clínica de bintrafusp alfa, en función de la DR
    - Evaluar la eficacia clínica de bintrafusp alfa, en función de la TRD
    - Evaluar la seguridad clínica de bintrafusp alfa
    - Evaluar la eficacia clínica en función de la SSP
    - Evaluar la TRO, la DR, la TRD y la SSP mediante la lectura del investigador
    - Evaluar la eficacia clínica en función de la SG
    - Caracterizar el perfil FC de bintrafusp alfa
    - Caracterizar la inmunogenia de bintrafusp alfa
    - Evaluar la eficacia clínica de bintrafusp alfa en función de la expresión de PD-L1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Study participants are ≥ 18 years of age at the time of signing the informed consent. In Japan, if a participant is at least 18 but < 20 years of age, written informed consent from his/her parent or guardian will be required in addition to the participant’s written consent.
    2. Participants have a histologically documented advanced unresectable and/or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) with disease progression during or after the prior platinum-containing chemotherapy:
    a. The prior platinum-containing chemotherapy may be a systemic treatment for metastatic disease or in the adjuvant or neo-adjuvant setting. There is no limit to the number of lines of prior systemic therapy.
    b. Participants who were intolerant to or ineligible for platinum-based chemotherapy are also eligible. All other inclusion/exclusion criteria (e.g. lab results) must still be met at study entry.
    c. Participants must be naïve to checkpoint inhibitors as described in Section 5.2 of the Protocol.
    3. Measurable disease outside the CNS according to RECIST 1.1 at Screening. Evidence of measurable disease outside the CNS must be confirmed by IRC prior to start of treatment.
    Note: Lesions within the CNS are to be considered as non-target lesions only. Lesions may be considered measurable regardless of prior irradiation. Target lesions should preferably be selected from areas that have not been irradiated, or appear not to have been irradiated,
    If necessary, target lesion may be selected from areas that have been, or appear to have been irradiated in the opinion of the assessor.
    4. Archival tumor tissue sample or newly obtained (preferred) core or excisional biopsy of a tumor lesion is mandatory and collected during the Screening period prior to enrollment.
    Fine needle aspirates are not acceptable.Tumor material must be suitable for biomarker assessment as described in the Laboratory Manual. If participant received local therapy
    (e.g., radiation therapy or chemoradiotherapy) after the archival tissue was taken, a new, acceptable biopsy will be required prior to study entry.
    5. Have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 at study entry and Day 1 of treatment with bintrafusp alfa.
    6. Life expectancy ≥ 12 weeks as judged by the Investigator.
    7. Have adequate organ function: (as defined in Section 5.1)
    8. Participants with known HIV infections are in general eligible if the following criteria are met (FDA Guidance on Cancer Clinical Trial Eligibility, March 2019): (as defined in Section 5.1)
    9. Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections are in general eligible if the following criteria are met (FDA Guidance on Cancer Clinical Trial Eligibility, March 2019):(as defined in Section 5.1)
    1. Los participantes tienen como mínimo 18 años de edad en el momento de firmar el formulario de consentimiento informado. En Japón, si una participante tiene al menos 18, pero menos de 20 años de edad, se requerirá el consentimiento informado por escrito de su progenitor o tutor además del consentimiento por escrito de la participante.
    2. Los participantes tienen un cáncer de cuello uterino en estadio avanzado irresecable y/o metastásico, documentado histológicamente (carcinoma epidermoide, adenocarcinoma, carcinoma adenoescamoso) con progresión de la enfermedad durante o después de la quimioterapia con platino previa:
    a. La quimioterapia con platino previa puede ser un tratamiento sistémico para la enfermedad metastásica o haberse usado en el contexto adyuvante o neoadyuvante. No hay un límite para el número de líneas de tratamiento sistémico previo.
    b. También son aptas las participantes que eran intolerantes a la quimioterapia con platino o que no eran aptas para recibirla. Todos los demás criterios de inclusión/exclusión (p. ej., resultados analíticos) deben seguir cumpliéndose en el momento de la incorporación al estudio.
    c. Las participantes no deben haber recibido previamente inhibidores del punto de control (véase el apartado 5.2).
    3. Enfermedad medible fuera del SNC, de acuerdo con los criterios RECIST 1.1, en la selección. Los indicios de enfermedad medible fuera del SNC deben ser confirmados por el CRI antes del inicio del tratamiento.
    Nota: Las lesiones en el SNC deben considerarse como lesiones no diana solamente. Las lesiones pueden considerarse medibles independientemente de la radioterapia previa. Las lesiones diana deben seleccionarse preferiblemente a partir de áreas que no hayan sido irradiadas, o que parezca que no han sido irradiadas. Si es necesario, se puede seleccionar la lesión diana de áreas que hayan sido o parezca que han sido irradiadas en opinión del evaluador.
    4. Es obligatoria la muestra de tejido tumoral de archivo o recién obtenida (preferible) mediante biopsia con aguja gruesa o por escisión de una lesión tumoral, y recogida durante el periodo de selección antes de la inscripción. Los aspirados con aguja fina no son aceptables. El material tumoral debe ser adecuado para la evaluación de biomarcadores tal como se describe en el Manual de laboratorio. Si la participante recibió tratamiento local (p. ej., radioterapia o quimiorradioterapia) después de que se hubiese obtenido el tejido de archivo, se requerirá una biopsia nueva aceptable antes de entrar en el estudio.
    5. Tener un EF de 0 a 1 según el Grupo Oncológico Cooperativo del Este (ECOG) en el momento de la incorporación al estudio y el día 1 de tratamiento con bintrafusp alfa.
    6. Esperanza de vida ≥ 12 semanas según el criterio del investigador.
    7. Tener una función orgánica adecuada (tal y como se define en la sección 5.1):
    8. Las participantes con infección por VIH conocida son, en general, aptas si se cumplen los criterios siguientes (FDA Guidance Cancer Clinical Trial Eligibility, March 2019): (tal y como se define en la sección 5.1)
    9. Las participantes con infecciones por el virus de la hepatitis B (VHB) y/o el virus de la hepatitis C (VHC) son, en general, aptas si se cumplen los criterios siguientes (FDA Guidance Cancer Clinical Trial Eligibility, March 2019): (tal y como se define en la sección 5.1)
    E.4Principal exclusion criteria
    1. Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study treatment. NB Lesions in the CNS at baseline must be assessed as non-target lesions only.
    2. Participants with interstitial lung disease or has had a history of pneumonitis that has required oral or intravenous (IV) steroids.
    3. Participants with significant acute or chronic infections.
    4. Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
    5. Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia.
    - Other protocol defined exclusion criteria could apply.
    1. Quedan excluidas las participantes con metástasis activas en el sistema nervioso central (SNC) que presenten síntomas o metástasis que requieran intervención terapéutica. Las participantes con antecedentes de metástasis tratadas en el SNC (mediante cirugía o radioterapia) no son aptas, a menos que se hayan recuperado por completo del tratamiento, hayan demostrado ausencia de progresión durante al menos 4 semanas y no estén usando corticoesteroides durante al menos 7 días antes de comenzar el tratamiento del estudio. Las lesiones de NB en el SNC al inicio se deben evaluar como lesiones no diana solamente.
    2. Participantes con enfermedad pulmonar intersticial o que han tenido antecedentes de neumonitis que ha requerido corticoestoroides i.v. u orales.
    3. Participantes con infecciones agudas o crónicas importantes.
    4. Enfermedad autoinmunitaria activa que podría empeorar al recibir un agente inmunoestimulante.
    5. Participantes con enfermedad cardiovascular/cerebrovascular clínicamente significativa, como: accidente cerebrovascular/ictus, infarto de miocardio, angina de pecho inestable, insuficiencia cardíaca congestiva o arritmia cardíaca grave.
    - Podrían aplicar otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    - Confirmed objective response according to RECIST 1.1 assessed by an IRC
    - Respuesta objetiva confirmada según RECIST 1.1, evaluada por un CRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from first treatment to planned final assessment at approximately 2 years.
    Tiempo desde el primer tratamiento hasta la evaluación final paneada a los dos años aproximadamente.
    E.5.2Secondary end point(s)
    1. DOR according to RECIST 1.1 assessed by an IRC
    2. Durable response of at least 6 months according to RECIST 1.1 assessed by an IRC
    3. Occurrence of TEAEs and treatment-related AEs including AEs of special interest
    4. PFS according to RECIST 1.1 assessed by an IRC
    5. Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
    6. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
    7.Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
    8. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
    9. OS
    10. The concentration observed immediately at the end of infusion (CEOI) of bintrafusp alfa
    11. The concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration [Ctrough] for multiple dosing) of bintrafusp alfa
    12. Immunogenicity of bintrafusp alfa as measured by ADA assay from Screening through Safety Follow-up Visit (up to 28 days after last treatment)
    13. Efficacy endpoints by PD-L1 expression in tumor
    1. DR según RECIST 1.1 evaluada por un CRI
    2. Respuesta duradera de al menos 6 meses según RECIST 1.1 evaluada por un CRI
    3. Aparición de AAST y AA relacionados con el tratamiento, incluidos los AA de especial interés.
    4. SSP según RECIST 1.1 evaluada por un CRI
    5. Respuesta objetiva confirmada según RECIST 1.1 evaluadas por el investigador
    6. Duración de la respuesta según RECIST 1.1 evaluada por el investigador
    7. Respuesta duradera según los criterios de evaluación de respuesta en tumores sólidos (RECIST versión 1.1) evaluada por el investigador
    8. Supervivencia libre de progresión (SLP) según los criterios de evaluación de respuesta en tumores sólidos (RECIST versión 1.1) evaluada por el investigador
    9. SG
    10. La concentración observada inmediatamente al final de la perfusión (CEOI) de bintrafusp alfa
    11. La concentración observada inmediatamente antes de la siguiente dosis (correspondiente a la concentración previa o mínima [CFDI] para dosis múltiples) de bintrafusp alfa
    12. Inmunogenicidad de bintrafusp alfa medido por el ensayo ADA desde el cribado hasta la visita de seguimiento de seguridad (hasta 28 días después del último tratamiento)
    13. Criterios de valoración de la eficacia en función de la expresión de PD-L1 en el tumor
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from first treatment to planned final assessment at approximately 2 years
    Tiempo desde el primer tratamiento hasta la evaluación final paneada a los dos años aproximadamente.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned9
    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
    Argentina
    Australia
    Belgium
    Brazil
    China
    France
    Japan
    Korea, Republic of
    Russian Federation
    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 end of the study is defined as the date when 67% of the 135 participants (90 participants) died
    or each participant was followed up for at least 3 years after the first dose, whichever occurs first.
    El final del estudio se define como la fecha en que murió el 67% de los 135 participantes (90 participantes)
    o en que cada participante fue seguido durante al menos 3 años después de la primera dosis, lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days19
    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: 122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 135
    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)
    Standard of Care, or, for participants still benefitting from the IMP access is provided via a rollover study, expanded access, marketed product, or another mechanism of access as appropriate.
    Atención médica estándar, o, para los participantes que aún se beneficien del PI, se proporciona el acceso a través de un estudio de extensión, acceso ampliado, producto comercializado u otro mecanismo de acceso, según corresponda.
    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 Decision2020-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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