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    Summary
    EudraCT Number:2018-003711-21
    Sponsor's Protocol Code Number:MS100070_0176
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2018-003711-21
    A.3Full title of the trial
    An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies
    Estudio abierto, multicéntrico y de seguimiento para recopilar datos a largo plazo sobre participantes de varios estudios clínicos con avelumab (MSB0010718C)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avelumab Rollover Study
    Estudio de extensión del programa con Avelumab
    A.3.2Name or abbreviated title of the trial where available
    Avelumab Program Rollover Study
    Estudio de extensión del programa con Avelumab
    A.4.1Sponsor's protocol code numberMS100070_0176
    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 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 Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post codeD-64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+34900810844
    B.5.5Fax number+496151 72 20003
    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 Yes
    D.2.1.1.1Trade name Bavencio
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    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.3.4Pharmaceutical 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 INNAVELUMAB
    D.3.9.1CAS number 1537032-82-8
    D.3.9.3Other descriptive nameAnti-PD-L1
    D.3.9.4EV Substance CodeSUB180078
    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 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
    Solid Tumors
    Tumores solidos
    E.1.1.1Medical condition in easily understood language
    Solid Tumors
    Tumores solidos
    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 10065252
    E.1.2Term Solid tumor
    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 monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study
    Para controlar la seguridad y la tolerabilidad de avelumab en participantes con tumores sólidos que continúan el tratamiento con avelumab en el mismo régimen de tratamiento que en el estudio previo de avelumab
    E.2.2Secondary objectives of the trial
    - To evaluate the overall survival (OS) (for NSCLC, RCC, UC, and ovarian cancer indications only)

    - To evaluate the progression free survival (PFS)

    - To evaluate duration of response (DR)
    - Para evaluar la supervivencia general (OS) (solo para indicaciones de cáncer de ovario, CPNM, CCR y CU)

    - Evaluar la supervivencia libre de progresión (SLP).

    - Evaluar la duración de la respuesta (DR).



    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of Merck KGaA
    - Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
    - Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
    - Participantes bajo inscripción y tratamiento en un estudio clínico de avelumab bajo el patrocinio de Merck KGaA
    - Los participantes actualmente inscritos en un estudio previo de avelumab y están en tratamiento activo con avelumab o en un seguimiento de supervivencia a largo plazo después del tratamiento
    - Los participantes en tratamiento activo deben aceptar continuar usando anticonceptivos altamente efectivos (es decir, métodos con una tasa de fracaso de menos del 1% por año) para los participantes masculinos y femeninos si existe el riesgo de concepción.
    E.4Principal exclusion criteria
    - Participants who are pregnant or breastfeeding
    - Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients
    - Participant has been enrolled in the comparator arm of avelumab parent study
    - Participant has been withdrawn from avelumab parent study for any reason
    - Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study
    - Participantes embarazadas o en periodo de lactancia.
    - Participantes aún en tratamiento activo: hipersensibilidad conocida a cualquiera de los ingredientes de intervención del estudio
    - El participante se ha inscrito en el brazo comparador del estudio previo de avelumab
    - El participante ha sido retirado del estudio previo de avelumab por cualquier motivo.
    - Cualquier otra razón que, en opinión del investigador, impida que el participante participe en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study
    Aparición de eventos adversos no serios relacionados con el tratamiento (TEAE) relacionados con el tratamiento, todos los eventos adversos graves (SAE), eventos adversos relacionados con el sistema inmunitario (irAE) y reacciones relacionadas con la perfusión según la versión del National Cancer Institute Common Technology Criteria para eventos adversos (NCI-CTCAE) utilizados en el estudio previo respectivo
    E.5.1.1Timepoint(s) of evaluation of this end point
    From enrolment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab).
    Desde la inscripción hasta el final del seguimiento de supervivencia (hasta 5 años después de que el último participante reciba la última dosis de avelumab).
    E.5.2Secondary end point(s)
    1 Number of Participants with Overall Survival (OS)
    2 Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
    3 Duration of Response (DR) Assessed from Complete Response (CR) or Partial Response (PR)
    1 Número de participantes con supervivencia general (OS)
    2 Supervivencia libre de progresión (SLP) según los criterios de evaluación de respuesta en tumores sólidos, versión 1.1 (RECIST v1.1)
    3 Duración de la respuesta (DR) estimada a partir de la respuesta completa (CR) o respuesta parcial (PR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 From baseline (parent study) up to 5 years
    2 From baseline (parent study) up to 5 years
    3 From baseline (parent study) up to 5 years
    1 Desde el inicio (estudio previo) hasta 5 años.
    2 Desde el inicio (estudio previo) hasta 5 años.
    3 Desde el inicio (estudio previo) hasta 5 años
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Belgium
    Brazil
    Bulgaria
    Chile
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    Turkey
    United Kingdom
    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
    End of the post-treatment follow-up period, defined in the clinical study protocol as being part of the study.

    If the study is not terminated for a reason given in Protocol Section 7.1, the survival follow-up will continue until up to a maximum of 5 years after the last participant receives the last dose of avelumab. This duration may be shortened at the discretion of the Sponsor for any given indication.
    Final del período de seguimiento posterior al tratamiento, definido en el protocolo del estudio clínico como parte del estudio.

    Si el estudio no finaliza por un motivo dado en la Sección 7.1 del Protocolo, el seguimiento de la supervivencia continuará hasta un máximo de 5 años después de que el último participante reciba la última dosis de avelumab. Esta duración puede acortarse a discreción del Patrocinador para cualquier indicación dada.
    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 days12
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days15
    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: 103
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 209
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 312
    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)
    Patients will be referred to their treating physician for further options after the study.
    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 Decision2019-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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