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    The EU Clinical Trials Register currently displays   37219   clinical trials with a EudraCT protocol, of which   6124   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-000433-30
    Sponsor's Protocol Code Number:UCL/17/0053
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-07-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000433-30
    A.3Full title of the trial
    Phase II Trial of Pembrolizumab and Radiotherapy in Cutaneous T cell lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Trial of Pembrolizumab and Radiotherapy in Cutaneous T cell lymphoma
    A.3.2Name or abbreviated title of the trial where available
    PORT
    A.4.1Sponsor's protocol code numberUCL/17/0053
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03385226
    A.5.4Other Identifiers
    Name:Funder referenceNumber:MISP# 52167
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp and Dohme (MSD)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRUK & UCL Cancer Trials Centre
    B.5.2Functional name of contact pointToyin Adedayo
    B.5.3 Address:
    B.5.3.1Street Address90 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076799860
    B.5.5Fax number02076799861
    B.5.6E-mailctc.port@ucl.ac.uk
    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.2.1.1.1Trade name Pembrolizumab (Keytruda)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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 namePembrolizumab (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 (MK-3475)
    D.3.9.1CAS number 1374853-91-4
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeAS1
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cutaneous T cell lymphoma
    E.1.1.1Medical condition in easily understood language
    Cutaneous T cell Lymphoma is a cancer that affects the skin (Cutaneous means related or affecting the skin). The cancer originates from T cell lymphocytes,a type of white blood cells.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10011677
    E.1.2Term Cutaneous T-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Would the addition of radiotherapy to pembrolizumab improve the response to treatment and is it safe to give?
    E.2.2Secondary objectives of the trial
    - What is the response to pembrolizumab prior to giving radiotherapy
    - Change in Global response from radiotherapy to the 9th infusion
    - Best Overall response
    - Shrinkage of any other tumours where radiotherapy was not directly targeting (abscopal effect)
    - Duration of response
    - Time to next treatment
    - Side effect of trial treatment, and how many patients experienced them?
    - What is the time from study entry to progression or death (Progression-free survival)
    - What is the time from study entry to death from any cause (Overall survival)
    - Investigation of the immune biomarkers of response to the trial treatment
    - Is there a change in quality of life from study to end of treatment?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥ 18 years
    -Diagnosis of Stage IB-IVB CTCL mycosis fungoides (MF)/Sézary Syndrome (SS)
    -Have relapsed, are refractory or progressed after at least 1 systemic therapy
    -Skin biopsy at the time of or within 6 months prior to study entry
    -Patients must have a total mSWAT (modified Severity Weighted Assessment Tool)
    score of ≥10 OR have 2 or more measurable tumours of any size. Of this area:
    o There should be at least 1 cutaneous lesion (MF) or a defined area of involved
    skin (erythrodermic MF or SS) which is an appropriate target for palliative
    radiotherapy (see radiotherapy section 8.3.2 for protocol defined min/max
    irradiated area)

    o There should be an area of skin involved by measurable Mycosis Fungoides/SS
    that will not be irradiated (to assess the abscopal effect of radiotherapy)
    -Have a minimum wash-out and adverse event (AE) recovery period from previous treatments (e.g. topical therapy, phototherapy, local radiotherapy, monoclonal antibody, systemic cytotoxic anticancer treatment or other novel agents) prior to the first dose of pembrolizumab, as detailed in section 6.2.1 of the trial protocol
    -Have ECOG performance status of 0 or 1
    -Life expectancy of at least 6 months
    -Demonstrate adequate organ function
    -Female patients of childbearing potential must have a negative urine or serum pregnancy test at pre-registration
    -Willing to comply with the contraception requirements
    -Written informed consent
    E.4Principal exclusion criteria
    -Received chemotherapy or targeted small molecule therapy within 4 weeks prior to study entry or has not recovered from adverse events due to agents administered >4 weeks earlier (except patients with ≤ grade 2 neuropathy)
    -Is currently or has participated in an IMP or device study within 4 weeks prior to the first dose of pembrolizumab
    -Received any other monoclonal antibody within 15 weeks prior to the first dose of pembrolizumab or has not recovered (≤ grade 1 or to baseline level) from adverse events due to agents administered >4 weeks earlier. The exception to this is alemtuzumab which should not have been administered in the previous 12 weeks.
    -Additional malignancy that is progressing or requires active treatment
    -Patients with known central nervous system (CNS) involvement with lymphoma
    -Hypersensitivity to pembrolizumab or its excipients
    -Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    -Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy
    -Current or prior use of immunosuppressive therapy within 7 days prior to start of treatment except the following: intranasal, inhaled, topical steroids or local steroid injections (eg. Intra-articular injection); systemic corticosteroids at physiologic doses (10mg/day or less of prednisolone or equivalent)
    -Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 therapy
    -Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
    -Has known history of, or any evidence of active, non-infectious pneumonitis
    -History of other pulmonary disease such as interstitial lung disease, emphysema or chronic obstructive pulmonary disease
    -Is pregnant or breastfeeding
    -Has a known history of active TB
    -Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with the subject’s participation for the full duration of the trial or to participate in the trial is not in the patient’s best interest, in the opinion of the treating investigator
    -Has known psychiatric or substance abuse disorders that would interfere with the requirements of the trial
    -Has a known history of HIV
    -Has known active Hepatitis B or Hepatitis C
    -Has received a live vaccine within 30 days prior to the planned start of study medication (see section 6.2.2 of the trial protocol)
    -Patients who have previously received a solid organ transplant
    -Patients who have previously received any allogeneic transplantation
    E.5 End points
    E.5.1Primary end point(s)
    Tumour response rate at infusion 9, typically 24 weeks after the first dose of pembrolizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be fully staged (TNMB) within 4 weeks prior to study entry. This staging at ‘screening’ will be used as baseline TNMB for comparison and future Global Response Assessment at the 9th pembrolizumab infusion, typically at 24 weeks.
    E.5.2Secondary end point(s)
    1- Response prior to delivery of radiotherapy
    2- Change in Global Response from the time of radiotherapy to the 9th infusion
    3- Best overall response
    4- Abscopal effect (measured by regression of pre-defined lesions which have not been irradiated)
    5- Duration of response
    6- Time to next treatment
    7- Safety and toxicity
    8- Progression-free survival
    9- Overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Global assessment at the time of radiotherapy
    2,3,4,5 - At the time of radiotherapy and at infusions 9 and 13 (typically at 12, 24 and 36 weeks respectively), and at the end of pembrolizumab treatment
    6- At infusions 6, 7, 8 and 9 (typically at weeks 15, 18, 21 and 24), then for patients on pembrolizumab every 3 weeks until up to 2 years after study entry
    7- Every 3 weeks until up to 2 years and 5 months after study entry
    8- Progression or death from any cause
    9- Death from any cause
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the trial will be when the last patient has their 2 year follow up visit or completed the follow up for safety monitoring (whichever occurs later) (i.e. 2 years and 5 months if the last patient completes 2 years of pembrolizumab treatment and is then followed up for 5 months for safety)
    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 months5
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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)
    Provision of the trial treatment is limited to up to 2 years after study entry.

    Patients will receive the local standard of care for their disease as required after the trial ends.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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