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    Summary
    EudraCT Number:2014-003929-17
    Sponsor's Protocol Code Number:CPDR001X2101
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-31
    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 number2014-003929-17
    A.3Full title of the trial
    Open label multicenter Phase I/II study of the safety and efficacy of PDR001 administered to patients with advanced malignancies
    Estudio de fase I/II, abierto, multicéntrico, de la eficacia y la
    seguridad de PDR001 administrado en pacientes con
    tumores malignos avanzados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An interventional study of PDR001 in patients with advanced malignancies
    Estudio de fase I/II de PDR001 en pacientes con tumores malignos avanzados.
    A.4.1Sponsor's protocol code numberCPDR001X2101
    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 SponsorNovartis Farmacéutica, 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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico Oncología (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.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.3.2Product code PDR001
    D.3.4Pharmaceutical form Powder 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 INNPDR001
    D.3.9.1CAS number PDR001
    D.3.9.2Current sponsor codePDR001
    D.3.9.3Other descriptive namePDR001
    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 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 sólidos
    E.1.1.1Medical condition in easily understood language
    Solid tumors
    tumores sólidos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    Phase I: To estimate the RP2D and/or the MTD for PDR001
    Phase II: To estimate the anti-tumor activity of PDR001
    Fase I: calcular la DRF2 y/o la DMT de PDR001.
    Fase II: estimar la actividad antitumoral de PDR001.
    E.2.2Secondary objectives of the trial
    1- To characterize the safety and tolerability of PDR001
    2- To characterize the pharmacokinetic profile of PDR001
    3- To further investigate the anti-tumor activity of PDR001
    1-Caracterizar la seguridad y la tolerabilidad de PDR001.
    2-Caracterizar el perfil farmacocinético de PDR001.
    3-Continuar investigando la actividad antitumoral de PDR001.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained prior to any screening procedures
    2. Patient (male or female) ? 18 years of age
    3. Phase I part: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 1), who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
    4. Phase II part: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have received standard therapy or are intolerant of standard therapy, have progressed following their last prior therapy, and fit into one of the following groups:
    ? Group 1: NSCLC
    ? Group 2: Melanoma
    ? Group 3: Triple negative breast cancer
    5. ECOG Performance Status ? 2.
    6. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at baseline, and during therapy on this study.
    Other protocol-defined inclusion criteria may apply
    1. Se debe obtener un consentimiento informado por escrito antes de realizar
    cualquier procedimiento de selección.
    2. Pacientes (hombres o mujeres) ? 18 años de edad.
    3. Fase I: Pacientes con tumores sólidos avanzados o metastásicos, con
    enfermedad medible o no medible determinada por RECIST versión 1.1
    (véase el Anexo 1) que hayan presentado progresión a pesar del tratamiento
    estándar, que sean intolerantes a este o para los que no exista tratamiento
    estándar.
    4. Fase II: Pacientes con tumores sólidos avanzados/metastásicos, con al menos
    una lesión medible determinada según los criterios RECIST versión 1.1, que
    hayan recibido tratamiento estándar o que sean intolerantes a este, que
    hayan progresado tras el último tratamiento previo y que encajen en uno de
    los grupos siguientes:
    - Grupo 1: CPCNP.
    -Grupo 2: melanoma.
    - Grupo 3: cáncer de mama triple negativo.
    5. Estado funcional ECOG ? 2.
    6. Los pacientes deben tener un lugar de enfermedad en el que se pueda realizar una biopsia y ser candidato para una biopsia del tumor. El paciente debe estar dispuesto a que se le realice una nueva biopsia tumoral en la basal y
    durante el tratamiento a lo largo del estudio.
    E.4Principal exclusion criteria
    1. History of severe hypersensitivity reactions to other mAbs
    2. Active autoimmune disease.
    3. Active infection requiring systemic antibiotic therapy.
    4. HIV infection.
    5. Active HBV or HCV infection.
    6. Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks washout period.
    7. Prior PD-1- or PD-L1-directed therapy.
    8. Patients requiring chronic treatment with systemic steroid therapy, other than replacement-dose steroids in the setting of adrenal insufficiency. Topical, inhaled, nasal and ophthalmic steroids are not prohibited.
    9. Patients receiving systemic treatment with any immunosuppressive medication (other than steroids as described above).
    10. Use of any vaccines against infectious diseases (e.g. influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
    11. Presence of ? CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? CTCAE grade 3) due to prior cancer therapy.
    Other protocol-defined exclusion criteria may apply
    1. Antecedentes de reacciones graves de hipersensibilidad a otros AMs.
    2. Enfermedad autoinmune activa.
    3. Infección activa que requiera tratamiento sistémico antibiótico.
    4. Infección por VIH.
    5. Infección por VHB o VHC activa.
    6. Tratamiento sistémico contra el cáncer en las dos semanas antes de la
    administración de la primera dosis del tratamiento del estudio. Para fármacos
    citotóxicos que tengan una importante toxicidad retardada, como mitomicina C
    y nitrosoureas, un periodo de lavado de 4 semanas.
    7. Tratamiento previo dirigido a PD-1- o PD-L1.
    8. Pacientes que requieran tratamiento crónico con esteroides sistémicos
    distintos de los esteroides administrados como terapia de sustitución para la
    insuficiencia suprarrenal. No se prohíben los esteroides tópicos, inhalados,
    nasales ni oftalmológicos.
    9. Pacientes que reciban tratamiento sistémico con cualquier medicación
    inmunosupresora (salvo los esteroides descritos más arriba).
    10. Uso de vacunas frente a enfermedades infecciosas (como gripe, varicela o
    neumococo) en las 4 semanas anteriores al comienzo del tratamiento del
    estudio.
    11. Presencia de toxicidad de grado ? 2 de los CTCAE (excepto alopecia,
    neuropatía periférica y ototoxicidad, que se excluyen en caso de grado ? 3 de
    los CTCAE) debido a un tratamiento contra el cáncer anterior.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    - The exposure (AUC(0-336h)) after first dose of treatment
    - The incidence of DLTs

    Phase II: Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    Fase I:
    - La exposición (AUC (0-336h)) después de la primera dosis de tratamiento
    - La incidencia de DLT

    Fase II: tasa de respuesta general (ORR) por los Criterios de Evaluación de Respuesta en Tumores Sólidos (RECIST) v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I:
    - The AUC(0-336h) : after first dose of treatment
    - the incidence of DLTs: in first cycle of treatment

    Phase II: Every 2 Cycles ± 1 week from Cycle 3 Day 1 up to Cycle 11 Day 1, then every 3 cycles until progression of disease per irRC or patient withdrawal.
    Fase I:
    - Las AUC (0-336h): después de la primera dosis de tratamiento
    - La incidencia de DLT: en primer ciclo de tratamiento

    Fase II: Cada 2 ciclos ± 1 semana a partir del Ciclo 3 Día 1 hasta 11 Ciclo Día 1, luego cada 3 ciclos hasta la progresión de la enfermedad por IRRC o retirada del paciente.
    E.5.2Secondary end point(s)
    1- Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory parameters, vital signs and electrocardiograms (ECGs)
    Tolerability: Dose interruptions, reductions and dose intensity
    2- Serum PK parameters (e.g., AUC, Cmax, Tmax, half-life); Serum concentration vs. time profiles
    3- Phase I: ORR, progression free survival (PFS), duration of response (DOR) and disease control rate (DCR)
    Phase II: ORR per immune related Response Criteria (irRC), PFS, DOR, DCR
    1- Seguridad: La incidencia y la gravedad de los acontecimientos adversos (AA) y los eventos adversos graves (AAG), incluyendo cambios en los parámetros de laboratorio, signos vitales y electrocardiogramas (ECG)
    La tolerabilidad: interrupciones, reducciones de dosis e intensidad de dosis
    Parámetros 2- Suero PK (por ejemplo, AUC, Cmax, Tmax, medio de vida); La concentración sérica vs. perfiles de tiempo
    3- Fase I: la ORR, supervivencia libre de progresión (SLP), tasa de control de duración de la respuesta (DOR) y la enfermedad (DCR)
    Fase II: la ORR por criterios relacionados con la respuesta inmune (RICR), PFS, DOR, DCR
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Every week until Cycle 1 Day 15. Every two weeks from Cycle 1 Day 15 until Cycle 3 Day 1. Every cycle from Cycle 3 Day 1 onwards.
    2. First half of cycle 1 and first half of cycle 3.
    3. Every 2 Cycles ± 1 week from Cycle 3 Day 1 up to Cycle 11 Day 1, then every 3 cycles until progression of disease per irRC or patient withdrawal.
    1. Cada semana hasta el ciclo 1 Día 15. Cada dos semanas a partir del Ciclo 1 día 15 hasta el Ciclo 3 Día 1. Cada ciclo desde el ciclo 3 Día 1 en adelante.
    2. Primera mitad del ciclo 1 y primera mitad del ciclo de 3.
    3. Cada 2 ciclos ± 1 semana desde Ciclo 3 Día 1 hasta el ciclo 11 Día 1, luego cada 3 ciclos hasta la progresión de la enfermedad por IRRC o retirada del paciente.
    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) Yes
    E.7.1.1First administration to humans Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    France
    Germany
    Japan
    Netherlands
    Spain
    Taiwan
    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 will be when 80% of the patients per disease group in the phase II part have completed the follow-up for disease progression or discontinued the study for any reason, and all patients have completed treatment and the 30 day safety follow-up period, or if the study is terminated early.
    El final del estudio se producirá cuando el 80 % de los pacientes por cada grupo de enfermedad de la fase II haya finalizado el seguimiento de la progresión de la enfermedad o haya abandonado el estudio por cualquier motivo y todos los pacientes hayan finalizado el tratamiento y el periodo de seguimiento de seguridad de 30 días, o si el estudio finaliza prematuramente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 121
    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)
    See the protocol
    Ver el protocolo
    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 Decision2015-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-21
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