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    Summary
    EudraCT Number:2015-001852-32
    Sponsor's Protocol Code Number:MK-3475-164
    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:2015-08-26
    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 number2015-001852-32
    A.3Full title of the trial
    A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects with Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)
    Estudio en fase II de pembrolizumab (MK 3475) en monoterapia en sujetos tratados previamente por un carcinoma colorrectal con alta inestabilidad de microsatélites o con reparación de errores de apareamiento deficiente, localmente avanzado irresecable o metastásico (estadio IV) (KEYNOTE 164)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study of Pembrolizumab in Previously Treated Subjects with Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma
    Estudio en fase II de pembrolizumab en sujetos tratados previamente por un carcinoma colorrectal con alta inestabilidad de microsatélites o con reparación de errores de apareamiento deficiente
    A.3.2Name or abbreviated title of the trial where available
    Phase II Study of Pembrolizumab in Subjects with MMRd or MSI-H CRC
    fase II de pembrolizumab en sujetos con MMRd o MSI-H CRC
    A.4.1Sponsor's protocol code numberMK-3475-164
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02460198
    A.5.4Other Identifiers
    Name:KEYNOTENumber:164
    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 Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) Yes
    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
    Colorectal Carcinoma
    Carcinoma colorrectal
    E.1.1.1Medical condition in easily understood language
    colorectal cancer
    cáncer colorrectal
    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
    The primary efficacy objective of this study is to evaluate the Overall Response Rate (ORR) per RECIST 1.1 assessed by central imaging vendor of the 200 mg Q3W dose of pembrolizumab in subjects with locally advanced unresectable or metastatic MMR deficient or MSI high CRC. Overall response rate (ORR) will be used as the primary endpoint per RECIST 1.1 assessed by the central imaging vendor.
    Evaluar la tasa de respuesta global (TRG) conforme a los criterios RECIST 1.1 según lo determinado por el laboratorio central de imagen con la dosis de 200 mg C3S de pembrolizumab en sujetos con CCR con alta IMS o REA deficiente localmente avanzado irresecable o metastásico.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives of this study are to evaluate the ORR per irRECIST and DOR, DCR, PFS per RECIST 1.1 and irRECIST as assessed by the central imaging vendor, and OS in subjects with locally advanced unresectable or metastatic MMR deficient or MSI-high CRC.
    Evaluar la TRG conforme a los criterios RECISTri, la duración de la respuesta (DR), la tasa de control de la enfermedad (TCE), la supervivencia sin progresión (SSP) conforme a los criterios RECIST 1.1 y RECISTri, según lo determinado por el laboratorio central de imagen, y la supervivencia global (SG).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Las muestras obtenidas para el banco biológico de Merck se emplearán para efectuar análisis basados en la buena práctica científica. Los análisis de las muestras para investigaciones biomédicas futuras podrán ser realizados por el promotor o por terceros (p. ej., un investigador universitario) designados por el promotor. El investigador que realice los análisis cumplirá los requisitos del promotor en cuanto a privacidad y confidencialidad. Los análisis efectuados por terceros contratados se ajustarán al ámbito específico del análisis descrito en este subestudio. Las muestras para investigaciones biomédicas futuras que sobren tras realizar el análisis específico se devolverán al promotor.
    E.3Principal inclusion criteria
    Subjects must: be male or female subjects who are ? 18 years of age on the day of signing the informed consent. Locally confirmed MMR deficient or MSI-h CRC. Have a histologically proven locally advanced unresectable or metastatic CRC (Stage IV). Have been previously treated with at least two lines of systemic therapies, which must include a fluoropyrimidine, oxaliplatin or irinotecan. Treatment given in the adjuvant setting can be counted as one line of therapy. Subjects who were discontinued from a line of systemic therapy due to unacceptable toxicity prior to progression of disease are also eligible. Have an ECOG performance status of 0 or 1. Have a life expectancy of greater than 3 months. Have at least one measureable lesion by RECIST 1.1 as determined by central review for response assessment.
    Los sujetos deberán: Ser varones o mujeres con 18 o más años de edad el día de la firma del consentimiento informado. Presentar un CCR con A-IMS o con REA deficiente confirmado localmente. Presentar un CCR localmente avanzado irresecable o metastásico histológicamente demostrado (estadio IV). Haber recibido anteriormente al menos dos líneas de tratamientos sistémicos, que deberán incluir una fluoropirimidina, oxaliplatino o irinotecán. El tratamiento administrado en el contexto adyuvante puede contabilizarse como una línea de tratamiento. Podrán participar también sujetos que hayan suspendido una línea de tratamiento sistémico debido a toxicidad inaceptable antes de la progresión de la enfermedad. Tener un estado funcional de 0 o 1 en la escala del ECOG. Tener una esperanza de vida mayor de tres meses. Presentar al menos una lesión cuantificable conforme a los criterios RECIST 1.1 según lo determinado por una revisión centralizada para la evaluación de la respuesta.
    E.4Principal exclusion criteria
    Subjects will be excluded if he/she: is currently participating in another study and receiving trial treatment, has participated in a study of an investigational agent and received trial treatment within 4 weeks of the first dose of treatment in this study, or used an investigational device within 4 weeks of the first dose of treatment in this study. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable brain metastases [without evidence of progression by imaging [confirmed by magnetic resonance imaging (MRI) if MRI was used at prior imaging, or confirmed by computed tomography (CT) imaging if CT used at prior imaging] for at least four weeks prior to the first dose of trial treatment; also, any neurologic symptoms must have returned to baseline], have no evidence of new or enlarging brain metastases, and have not used steroids for brain metastases for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, as subjects with carcinomatous meningitis are excluded regardless of clinical stability. Has had prior monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., < or = to Grade 1 or at baseline) from adverse events due to a previously administered agent. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or if the subject has previously participated in Merck pembrolizumab (MK-3475) clinical trials. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Has received a live vaccine within 30 days of planned start of study therapy. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Has known history of, or any evidence of interstitial lung disease or active, non-infectious pneumonitis.
    Has an active infection requiring systemic therapy.
    Estar participando en otro estudio y recibir tratamiento del ensayo, haber participado en un estudio de un fármaco en investigación y haber recibido tratamiento del ensayo en las 4 semanas previas a la primera dosis del tratamiento en este estudio, o haber usado un producto sanitario en investigación en las 4 semanas previas a la primera dosis del tratamiento en este estudio. Padecer una enfermedad autoinmunitaria que haya necesitado tratamiento sistémico en los dos años precedentes (es decir, fármacos modificadores de la enfermedad, corticosteroides o inmunodepresores). El tratamiento de restitución (por ejemplo, tiroxina, insulina o corticosteroides en dosis fisiológicas para una insuficiencia suprarrenal o hipofisaria, etc.) no se considera una forma de tratamiento sistémico. Tener un diagnóstico de inmunodeficiencia o haber recibido corticoterapia sistémica o algún tipo de tratamiento inmunodepresor en los 7 días previos a la administración de la primera dosis del tratamiento del ensayo. Presentar metástasis activas en el sistema nervioso central (SNC) o meningitis carcinomatosa. Los sujetos con metástasis cerebrales tratadas previamente podrán participar siempre que se encuentren estables [sin indicios de progresión en los estudios de imagen (confirmado mediante resonancia magnética (RM) si ese fue el método usado en el estudio de imagen anterior o confirmado mediante TAC si este fue el método empleado en el estudio de imagen anterior) durante al menos cuatro semanas antes de recibir la primera dosis del tratamiento del ensayo y regreso a la situación basal de los posibles síntomas neurológicos], no tengan indicios de metástasis cerebrales nuevas o en crecimiento y no hayan utilizado esteroides para las metástasis cerebrales desde como mínimo 7 días antes del tratamiento del ensayo. Esta excepción no se aplica a la meningitis carcinomatosa, puesto que los sujetos afectados por esta enfermedad estarán excluidos con independencia de la estabilidad clínica. Haber recibido quimioterapia previa con un anticuerpo monoclonal (AcM), un tratamiento dirigido con moléculas pequeñas o radioterapia en las 2 semanas anteriores al día 1 del estudio o no haberse recuperado (es decir, a un grado < = a 1 o al valor basal) de los acontecimientos adversos provocados por un fármaco administrado anteriormente. Haber recibido inmunoterapia previa con un fármaco anti PD 1, anti PD L1 o anti PD L2 o haber participado a anteriormente en ensayos clínicos de pembrolizumab (MK 3475) de Merck. Presentar otro tumor maligno conocido que esté en progresión o necesite tratamiento activo. Son excepciones el carcinoma basocelular de piel, el carcinoma espinocelular de piel que haya sido objeto de un tratamiento potencialmente curativo y el cáncer de cuello uterino in situ. Haber recibido una vacuna de microorganismos vivos en los 30 días previos al comienzo previsto del tratamiento del ensayo. Tener antecedentes o signos actuales de cualquier trastorno, tratamiento o anomalía analítica que, en opinión del investigador, pueda confundir los resultados del ensayo, afectar a la participación del sujeto durante todo el ensayo o hacer que la participación no sea lo más conveniente para ese sujeto. Tener antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH) (anticuerpos contra el VIH 1 o 2). Tener hepatitis B activa demostrada (por ejemplo, reactividad de HBsAg) o hepatitis C demostrada (por ejemplo, detección [cualitativa] de ARN del VHC). Presentar antecedentes conocidos o signos de neumopatía intersticial o de neumonitis no infecciosa activa. Presentar una infección activa con necesidad de tratamiento sistémico.
    E.5 End points
    E.5.1Primary end point(s)
    ORR based on RECIST 1.1 assessed by central imaging vendor
    Tasa de respuesta global (TRG) RECIST 1.1 según lo determinado por el laboratorio central de imagen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    There is one interim analysis planned in this study. If the enrollment rate is much faster than anticipated and it is projected that the final analysis will be within 6 months after the interim analysis, the interim analysis may not be performed.
    Está previsto realizar un análisis intermedio en este estudio. Si la velocidad de inclusión de los sujetos es mucho más rápida de lo esperado y se anticipa que el análisis final tendrá lugar en los 6 meses siguientes al análisis intermedio, no se podrá realizar el análisis intermedio
    E.5.2Secondary end point(s)
    Overall response rate (ORR) - irRECIST assessed by central imaging vendor
    Disease Control Rate (DCR) - RECIST 1.1 and irRECIST assessed by central imaging vendor
    Duration of Response (DOR) - RECIST 1.1 and irRECIST assessed by central imaging vendor
    Progression-free Survival (PFS) - RECIST 1.1 and irRECIST assessed by central imaging vendor
    Overall survival (OS)
    -Tasa de respuesta global (TRG) conforme a los criterios RECISTri, según lo determinado por el laboratorio central de imagen
    -Tasa de control de la enfermedad (TCE) conforme a los criterios RECIST1.1 e RECISTri, según lo determinado por el laboratorio central de imagen
    -Duración de la respuesta (DR) conforme a los criterios RECIST 1.1 eRECISTri, según lo determinado por el laboratorio central de imagen
    -Supervivencia sin progresión (SSP) conforme a los criterios RECIST 1.1 y RECISTri, según lo determinado por el laboratorio central de imagen.
    -Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Response assessments for endpoints are being evaluated throughout the study; imaging assessment to support the endpoints are obtained every 9 weeks.
    Las respuestas de evaluación para las variables serán evaluadas a lo largo del estudio. Las pruebas de evaluación de imagen apoyaran las evaluaciones de las variables y serán obtenidas cada 9 semanas
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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.8.3 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 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
    Australia
    Belgium
    France
    Germany
    Israel
    Japan
    Korea, Republic of
    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
    LPLV = Last Patient Last Visit
    LVLS= Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 60
    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 care after the study will be managed by the treating physician.
    Los pacientes serán tratados después del estudio bajo practica clínica habitual según indique su medico
    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 Decision2015-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-19
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