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    Summary
    EudraCT Number:2021-002457-29
    Sponsor's Protocol Code Number:B9991046
    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:2021-07-30
    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 number2021-002457-29
    A.3Full title of the trial
    AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER SPONSORED AVELUMAB CLINICAL STUDIES
    PROTOCOLO MAESTRO DE AVELUMAB: ESTUDIO ABIERTO DE CONTINUACIÓN PARA PARTICIPANTES QUE CONTINÚEN EN LOS ESTUDIOS CLÍNICOS DE AVELUMAB PATROCINADOS POR PFIZER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Master Protocol for Avelumab Continuation Study
    Protocolo maestro para el estudio de continuación de avelumab
    A.4.1Sponsor's protocol code numberB9991046
    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 SponsorPfizer Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1800 7181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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.3.1Product nameAvelumab
    D.3.2Product code MSB0010718C
    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 n/a
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.3Other descriptive nameMSB0010718C
    D.3.9.4EV Substance CodeSUB176547
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lorviqua
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 nameLorlatinib
    D.3.2Product code PF-06463922
    D.3.4Pharmaceutical form Tablet
    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 INNPF-06463922
    D.3.9.2Current sponsor codePF-06463922
    D.3.9.3Other descriptive namePF-06463922
    D.3.9.4EV Substance CodeSUB126819
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    This Master Protocol for Avelumab Continuation Sub-Studies has been designed to accommodate continued access to study intervention, safety follow-up, and when applicable, overall survival follow up, for eligible participants receiving study intervention and who continue to derive treatment benefit or who are in follow-up in a Pfizer-sponsored avelumab study (Parent Study)
    Este protocolo maestro para los subestudios de continuación de avelumab se ha diseñado para adaptarse al acceso continuado a la intervención del estudio, el seguimiento de seguridad y, cuando corresponda, el seguimiento de la supervivencia en general para los participantes elegibles que reciban la intervención del estudio y que sigan recibiendo beneficios del tratamiento o que estén en seguimiento en un estudio de avelumab patrocinado por Pfizer (estudio original), que se debe cerrar.
    E.1.1.1Medical condition in easily understood language
    N/A
    N/A
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 study intervention(s)
    A maximum of 9 sub studies and a maximum of 300 participants will be included in this Master Protocol for Avelumab Continuation Sub-Studies.
    - Protocol B9991046 (Parent Study B9991005), Amendment 1dd. 07 Jul 2021: AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE B9991005 AVELUMAB STUDY
    Objectives: To monitor the safety and tolerability of avelumab and lorlatinib
    - Protocol B9991046 (Parent Study B9991009), Amendment 1dd. 07 Jul 2021: AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE B9991009 AVELUMAB STUDY
    Objectives: To monitor the safety and tolerability of avelumab
    En este protocolo maestro para los subestudios de continuación de avelumab, se incluirá un máximo de 9 subestudios y 300 participantes.
    - Protocolo B9991046 (estudio original B9991005), Modificación 1 del protocolo del subestudio de continuación final, 07 de julio de 2021: ESTUDIO ABIERTO PARA EL ACCESO CONTINUO AL TRATAMIENTO DE LOS PARTICIPANTES DEL ESTUDIO DE AVELUMAB B9991005
    Objetivos: Supervisar la seguridad y tolerabilidad de avelumab y lorlatinib

    - Protocolo B9991046 (estudio original B9991009), Modificación 1 del protocolo del subestudio de continuación final, 07 de julio de 2021: ESTUDIO ABIERTO PARA EL ACCESO CONTINUO AL TRATAMIENTO DE LOS PARTICIPANTES DEL ESTUDIO B9991009 AVELUMAB
    Objetivos: realizar un seguimiento de la seguridad y tolerabilidad del Avelumab
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all the following criteria apply:
    1.Any participant who is receiving study treatment and deriving significant clinical benefit (as determined by the Principal Investigator) or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study.
    2.Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Avelumab Continuation Sub-Study Protocol.
    3.Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the appliable Avelumab Continuation Sub-Study Protocol.
    4.Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    1. Cualquier participante que reciba el tratamiento del estudio y beneficios clínicos significativos (según lo determine el investigador principal) o que se encuentre en el periodo de seguimiento de seguridad o supervivencia en un estudio original de avelumab patrocinado por Pfizer.
    2. Los participantes deben aceptar seguir los criterios reproductivos descritos en el Apéndice 4 (Sección 10.4.1 para hombres y Sección 10.4.2 para mujeres) del protocolo del subestudio de continuación de avelumab aplicable.
    3. Participantes que estén dispuestos y sean capaces de cumplir con todas las visitas programadas, el plan de tratamiento y otros procedimientos del estudio, según lo descrito en el protocolo del subestudio de continuación de avelumab.
    4. Capacidad de dar el consentimiento informado firmado, tal como se describe en el Apéndice 1, Sección 10.1.3, que incluye el cumplimiento de los requisitos y las restricciones que figuran en el DCI y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1.Female participants who are pregnant or breastfeeding.
    2.Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
    Los participantes se excluyen del estudio si se aplica alguno de los siguientes criterios:
    1. Participantes de sexo femenino embarazadas o en periodo de lactancia.
    2. Cualquier razón médica que, a criterio del investigador o patrocinador, impida la inclusión del participante en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    AEs leading to permanent discontinuation of study interventiona
    All SAEs
    • AA que conducen a la interrupción permanente de la intervención del estudio
    • Todos los AAG
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Australia
    Russian Federation
    Belgium
    France
    Spain
    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 this Master Protocol is defined as when the last participant in the last Avelumab Continuation Sub-Study has come off study, or 5 years after study initiation (whichever is sooner). However, the Sponsor may terminate the Master Protocol for Avelumab Continuation Sub-Studies or Continuation Study/ies at any time.
    Se define que el final de este protocolo maestro es cuando el último participante del último subestudio de continuación de avelumab se retira del estudio o 5 años después del inicio del estudio (lo que ocurra primero). Sin embargo, el patrocinador puede finalizar en cualquier momento el protocolo maestro para los subestudios de continuación de avelumab o los estudios de continuación.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) No
    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 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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 300
    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
    Ninguno
    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 Decision2021-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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