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    Summary
    EudraCT Number:2017-004168-36
    Sponsor's Protocol Code Number:UCL/17/0672
    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:2019-06-07
    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 number2017-004168-36
    A.3Full title of the trial
    A phase II study of pembrolizumab in patients with advanced gynaecological clear cell cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study testing the effectiveness of an immunotherapy cancer drug called pembrolizumab, in patients who have progressed with gynaecological cancer, called clear cell cancer.
    A.3.2Name or abbreviated title of the trial where available
    PEACOCC
    A.4.1Sponsor's protocol code numberUCL/17/0672
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03425565
    A.5.4Other Identifiers
    Name:Funder's (MSD) reference Number:MISP 55357
    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 & Dohme Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCancer Research UK & UCL Cancer Trials Centre
    B.5.2Functional name of contact pointLaura Hughes
    B.5.3 Address:
    B.5.3.1Street Address90 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076799284
    B.5.5Fax number02076799871
    B.5.6E-mailctc.peacocc@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.2.5The 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 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
    Advanced Gynaecological Clear Cell Cancer
    E.1.1.1Medical condition in easily understood language
    Gynaecological clear cell cancer is a rare cancer which has spread (progressed) from the ovary(ies), fallopian tube), womb, vaginal, vulva or cervix.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10009252
    E.1.2Term Clear cell endometrial carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10046885
    E.1.2Term Vaginal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047741
    E.1.2Term Vulval cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether pembrolizumab can control or reduce tumour safely and effectively in a significant number of women at 12 weeks (progression free survival rate) with advanced clear cell gynaecological cancer.

    E.2.2Secondary objectives of the trial
    • To assess whether the study drug pembrolizumab prolongs the time it takes before the cancer grows on study on study and/or prolongs the patients' survival.
    • To assess whether a second treatment period with pembrolizumab prolongs the time it takes before the cancer grows back and/or prolongs the patients' survival.
    • To assess the effect of pembrolizumab on the overall tumour response rate at 12 weeks, and best tumour response rate over the entire study.
    • To assess the duration of response.
    • To assess quality of life during treatment with pembrolizumab.
    • To assess any side-effects of the drug.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological diagnosis of advanced gynaecological cancer including ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
    2. Be willing and able to provide written informed consent/assent for the trial.
    3. Age ≥18 years.
    4. Patient must have at least one measurable lesion according to RECIST v1.1 in addition to a separate biopsiable lesion. Measurable lesions should be outside any prior radiation field unless progression has occurred at that site.
    5. Have measurable disease according to RECIST v1.1.
    6. Evidence of radiological disease progression.
    7. Patient is willing to provide archival tissue.
    8. ECOG Performance Status 0 or 1.
    9. Patient has a life expectancy of at least 4 months from consent.
    10. Received ≥ 1 line of prior chemotherapy.
    11. Demonstrate adequate organ function.
    12. For patients of childbearing potential, negative urine or serum pregnancy test prior to receiving the first dose of study medication.
    13. Patients of childbearing potential must be willing to use a highly effective method of contraception for the study duration required.
    E.4Principal exclusion criteria
    1. Patient is currently participating in and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
    2. Prior anti-cancer monoclonal antibody (mAb), chemotherapy or targeted small molecule therapy within 4 weeks prior to study treatment Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
    3. Radiation therapy within 2 weeks prior to starting study treatment.
    4. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent.
    5. Known diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses > 10mg prednisolone daily or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    6. Has a known history of active bacillus tuberculosis (TB).
    7. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] detected) infection.
    8. Known history of Human Immunodeficiency Virus (HIV) (HIV type 1/2 antibodies).
    9. Known hypersensitivity to pembrolizumab or any of its excipients.
    10. Known additional malignancy that is progressing or requires active treatment. If there is a history of a second malignancy and there is doubt regarding the aetiology of progressive disease, then a biopsy is required to determine the diagnosis.
    11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
    12. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (at a dose >10mg predisolone daily or equivalent) or immunosuppressive drugs).
    13. Corrected serum calcium of grade 1 hypercaelcemia (>2.9 mmol/L) despite maximal antihypercalcaemic therapy.
    14. Has a known history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    15. Newly diagnosed venous thromboembolic event (eg pulmonary embolism, deep vein thrombosis DVT), unless patient has received at least 14 days of therapeutic dose anticoagulation for a new thromboembolic event and is suitable for continued therapeutic anticoagulation during trial participation.
    16. History of arterial thrombosis (excluding the pulmonary artery), within 12 months prior to registration (if beyond 12 months prior to registration, patient may be included providing they have fully recovered clinically).
    17. Active infection requiring systemic therapy (for example antibiotics, antivirals, antifungals).
    18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
    19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    20. Pregnant or breastfeeding.
    21. Has received a live vaccine within 30 days prior to the planned start of trial treatment.
    22. Has been hospitalised for bowel obstruction within 4 weeks prior to registration.
    23. Current abdominal/pelvic fistulation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression free survival (PFS) rate at 12 weeks. This population of patients has very poor survival in the second line setting, therefore an improvement in survival at 12 weeks is a meaningful outcome. PFS rate also captures patients that have stable disease, which may be the earliest indication of benefit with an immunotherapeutic agent.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluation of the primary outcome measure will be 12 weeks from the start of the patient's treatment.

    The number of patients with complete or partial response or stable disease maintained at 12 weeks will be considered as having progression free survival at 12 weeks.
    E.5.2Secondary end point(s)
    1. Progression-free survival (PFS)

    2. Time to second disease progression (Re-treatment period)
    Time to second disease progression refers to second progression in patients re-treated on trial post first progression. All deaths will be included, whether they occur during the re-treatment period or following treatment discontinuation. For patients who have not died or progressed, progression-free survival will be censored at the date of last contact.

    3. Overall survival.

    4. Objective response rate at 12 weeks and best objective response rate
    Objective response is defined as a complete or partial tumour response as determined by RECIST v1.1. The best objective response consists of the best among all objective responses assessed.

    5. Duration of Response
    For patients with an objective response, duration of objective response is defined as the time from initial complete or partial response to disease progression or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first.

    For patients with disease control (objective response or stable disease maintained ≥12 weeks), duration of disease control is defined as the time from start of treatment to disease progression or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first.

    6. Safety Monitoring
    All patients who received at least one cycle of pembrolizumab will be included in the safety analysis. Adverse events (AEs) will be monitored on an ongoing basis and their frequencies reported. AEs will be categorized using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5. The worst event for each patient will be described. Both events related and unrelated to treatment will be captured.

    7. Quality of Life (QoL)
    The questionnaire used will be FACT-O (version 4). QoL data will be analysed using methods for repeated measures. The algorithm for core construction will be based on that provided by the FACT-O manual.


    E.5.2.1Timepoint(s) of evaluation of this end point
    1. PFS is defined as the time from start of treatment to progression or death from any cause (whichever comes first).

    2. Time to second disease progression is defined as the time from diagnosis of first progression to second progression, or death from any cause (whichever comes first).

    3. Overall Survival
    Overall survival is defined as the time from start of treatment to death from any cause.

    4. Objective Response Rate (at 12 weeks and best) will be calculated from the start of treatment.

    5. Duration of response will be evaluated from the time of initial response until progression or death on trial.

    6. Safety monitoring will be evaluated from consent until the last patient's visit.

    7. QoL
    Mean scores will be presented at each time point, as well as changes from baseli
    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 No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA5
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years6
    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.1.1Number 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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 0
    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)
    After the trial patients complete their last follow-up visit / withdraw from participation in the trial, they will be cared for as per local practice. There is no trial requirements that will dictate the patients' specific treatment or care thereafter. Any treatment or care decision, will be at the discretion of the local clinicians.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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