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    Summary
    EudraCT Number:2015-005053-12
    Sponsor's Protocol Code Number:MK3475-204
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-05-04
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2015-005053-12
    A.3Full title of the trial
    A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma
    Randomizované, nezaslepené klinické hodnocení fáze III, jehož cílem je porovnat léčbu přípravkem Pembrolizumab s léčbou přípravkem Brentuximab Vedotin u subjektů s relabujícím či refrakterním klasickým Hodgkinovým lymfomem.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Keytruda® will be compared to Adcetris® in this study to find out how effective and safe Keytruda is in treating a cancer called Hodgkin lymphoma.
    A.3.2Name or abbreviated title of the trial where available
    Phase III trial of pembrolizumab or brentuximab vedotin in Hodgkin lymphoma
    A.4.1Sponsor's protocol code numberMK3475-204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02684292
    A.5.4Other Identifiers
    Name:IND numberNumber:118604
    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.
    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.
    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 Corp.
    B.5.2Functional name of contact pointGlobal Clinical Trial Operation
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, Whitehouse Station
    B.5.3.2Town/ cityNew Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305 0829
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Adcetris
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 nameBrentuximab Vedotin
    D.3.4Pharmaceutical form Powder for 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 INNBrentuximab Vedotin
    D.3.9.1CAS number 914088-09-8
    D.3.9.3Other descriptive nameCD30-directed monoclonal antibody
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Relapsed or refractory classical Hodgkin lymphoma
    E.1.1.1Medical condition in easily understood language
    A cancer of the lymph glands that improved and then returned or did not improve in patients given with the usual treatments for this cancer
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    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 compare progression free survival (PFS) as assessed by blinded independent central review according to the American Society of Clinical Oncology International Working Group (IWG) response criteria [Cheson, 2007] between the treatment arms (pembrolizumab or brentuximab vedotin).

    To compare overall survival (OS) between treatment arms.
    E.2.2Secondary objectives of the trial
    To compare the complete remission rate (CRR) as assessed by blinded independent central review according to the IWG response criteria [Cheson, 2007] between treatment arms.

    To compare the overall response rate (ORR) as assessed by blinded independent central review according to the IWG response criteria [Cheson, 2007] between treatment arms.

    To evaluate PFS, CRR, and ORR as assessed by the investigator according to the IWG response criteria [Cheson, 2007] by treatment arm.

    To evaluate the safety and tolerability of pembrolizumab.
    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 and tissue) specimens collected during this clinical trial if the subject consents to participate in this research. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) 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.
    E.3Principal inclusion criteria
    – ≥18 years of age
    – Relapsed or refractory classical Hodgkin lymphoma
    – Measurable disease on spiral computed tomography (CT)
    – Evaluable core or excisional lymph node biopsy
    – Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    – Adequate organ function (laboratory studies)
    – Negative pregnancy/lactation
    – Adequate contraception (males and females)
    Refer to the protocol for more detail on each inclusion criterion.
    E.4Principal exclusion criteria
    1. Has received previous treatment with brentuximab vedotin.
    2. Has hypersensitivity to the active substance or to any of the excipients in brentuximab vedotin.
    3. Is currently participating in a study of an investigational agent and is currently receiving study therapy or has participated in a study of an investigational agent and has received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
    4. Has a diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    5. Has had a prior monoclonal antibody within 4 weeks prior to first dose of therapy in the study or who has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier.
    6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to a previously administered agent.
    7. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
    8. Has a known additional malignancy that is progressing or requires active treatment.
    9. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by magnetic resonance imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline) and have no evidence of new or enlarging brain metastases.
    10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
    11. Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
    12. Has an active infection requiring intravenous systemic therapy.
    13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment.
    15. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD30, anti-CD137, or CTLA4 antibody (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
    16. Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
    17. Has active hepatitis B (HBV) (e.g., HBsAg reactive) or hepatitis C (HCV) (e.g., HCV RNA [qualitative] is detected).
    18. Has received a live vaccine within 30 days prior to first dose.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy objective of this trial is to compare the anti-tumor activity of 200-mg pembrolizumab versus 1.8 mg/kg brentuximab vedotin in subjects with relapsed or refractory diagnosed classical Hodgkin lymphoma (HL) who have not been previously treated with brentuximab vedotin.

    The primary efficacy endpoints in this trial will be progression free survival (PFS) as assessed by blinded independent central review and defined as the time from randomization to the first documentation of lymphoma progression or death as a result of any cause [Cheson, 2007] and overall survival (OS) as a co primary endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim PFS analysis is planned 3 months after all subjects are enrolled and 110 PFS events are observed (approximately 15 months after trial starts).
    A final PFS analysis is planned after 221 PFS events are observed (approximately 21 months after trial starts).
    An interim OS analysis is planned after 91 OS events (anticipated at 21 months).
    A final OS analysis is planned after 146 OS events are observed (approximately 35 months after the trial starts).
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints in this trial will be CRR and ORR as assessed by blinded independent central review and PFS, CRR, and ORR as assessed by the investigator according to IWG response criteria [Cheson, 2007].

    Safety will be assessed by reported adverse events (AEs) using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The safety endpoints include any AE, Grade 3-5 AE, serious AE, drug-related AE, serious and drug-related AE, Grade 3-5 and drug-related AE, dose modification due to AE, discontinuation due to AE, and death. Specific AEs and system organ classes (SOCs) (including ≥4 subjects in one of the treatment groups), specific AEs and SOCs (incidence <4 subjects in all of the treatment groups), and change from baseline results (laboratory tests, electrocardiograms, and vital signs) will also be included.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary efficacy endpoints will be evaluated as part of the trial’s final analyses.
    Safety endpoints will be evaluated at each of time points specified for the primary efficacy endpoints.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Israel
    Italy
    Japan
    Poland
    Russian Federation
    South Africa
    Sweden
    Turkey
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    If it is the last visit of the last subject, please enter "LVLS". If it is not LVLS provide the definition: LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months40
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months40
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    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)
    30 days FU for AEs and ECIs and 90 days FU for SAEs. Spontaneously reported pregnancies will be FU for 180 days or 30 days is subject initiates new anticancer therapy. Subjects who discontinue for reasons other than disease progression will have post-treatment FU for disease status until disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to FU.OS will be assessed until death withdrawal of consent, or the end of 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 Decision2017-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
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