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    The EU Clinical Trials Register currently displays   37220   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-003792-63
    Sponsor's Protocol Code Number:UCL/17/0629
    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:2018-09-06
    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 number2017-003792-63
    A.3Full title of the trial
    Phase II trial of maintenance pembrolizumab following weekly paclitaxel for recurrent ovarian, fallopian tube or peritoneal cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROMPT is a research study investigating patients with recurrent ovarian, fallopian tube or peritoneal cancer, who have previously been treated with weekly paclitaxel. This study will address whether such patients may benefit from maintenance treatment with pembrolizumab.
    A.3.2Name or abbreviated title of the trial where available
    PROMPT
    A.4.1Sponsor's protocol code numberUCL/17/0629
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03430700
    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 Limited
    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 pointPROMPT Trial Coordinator
    B.5.3 Address:
    B.5.3.1Street Address90 Tottenham Court Road
    B.5.3.3Post codeW1T 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076799872
    B.5.5Fax number08076799871
    B.5.6E-mailctc.prompt@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
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether pembrolizumab significantly extends the length of time (during and after treatment) that a patient lives with cancer without it getting worse.
    E.2.2Secondary objectives of the trial
    We will investigate the following:
    - The length of time a patient lives with cancer without it getting worse
    - How long patients live
    - In how many patients does the cancer shrink
    - Side effects of pembrolizumab
    - Details of any further treatment if the cancer gets worse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    1. Patients must have a diagnosis of high grade recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer

    2. Be willing and able to provide written informed consent for the trial, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options

    3. Be  18 years of age on day of signing informed consent
    4. Patients should be treated with at least 4 cycles of weekly paclitaxel for their first non-platinum-based therapy. [Non-platinum-based therapy given for CT/MR documented recurrence where further platinum therapy considered unsuitable]
    5. Patients can have had up to 2 prior lines of treatment for ovarian cancer before starting weekly paclitaxel
    6. Patients must have achieved at least stable disease or response to a minimum for four cycles of weekly paclitaxel (measured by CT/MR)

    7. Trial treatment must start within 8 weeks after last paclitaxel dose

    8. Availability of archival tissue

    9. Patient has disease amenable to biopsy after paclitaxel

    10. Patient is willing to have a biopsy at baseline and before start of the 4th cycle of pembrolizumab

    11. CT chest, abdominal and pelvic scan within 28 days of registration

    12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    13. Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits

    14. Demonstrate adequate organ function as defined in Table 1 of protocol, all screening labs should be performed within 10 days of treatment initiation.

    15. For patients of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
    16. For patients of childbearing potential (defined in Section 6.3.1) must be willing to use an adequate method of contraception as outlined in Section 6.3.4 from the start of treatment through to 4 months after the last dose of study medication



    E.4Principal exclusion criteria
    1. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
    2. Has a diagnosis of low grade or mucinous ovarian cancer
    3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (n.b. the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC), excepting use of inhaled steroids.
    4. Has a known history of active TB (Bacillus Tuberculosis)
    5. Has known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known Hepatitis C virus (defined as HCV RNA [qualitative] is detected)*
    6. Has a known history of Human Immunodeficiency Virus (HIV). *
    7. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to randomisation.
    Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
    Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
    8. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
    9. Patients with concurrent or previous malignancy within the last 5 years (except Stage I grade 1 endometrial cancer; in situ cervical cancer; DCIS of the breast) that could compromise assessment of the primary or secondary endpoints of the trial
    10. Active central nervous system (CNS) metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are:
    a) radiologically stable
    b) without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening)
    c) clinically stable
    d) without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.

    11. Has active autoimmune disease that required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids (at doses >10mg prednisolone daily or equivalent) or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted
    12. Has a corrected serum calcium of >1.5 x ULN despite maximal anti-hypercalcaemic therapy
    13. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis or has a history of interstitial lung disease
    14. Has a newly diagnosed venous thrombotic event (e.g. PE, DVT) untreated with anticoagulation. Patients must have received at least 14 days of anticoagulation for a new thrombotic event and be suitable for continued therapeutic anticoagulation during trial participation. Patients are excluded if they have a history of arterial thrombosis
    15. Has an active infection requiring systemic therapy
    16. Has symptoms of bowel obstruction in the past three months
    17. Any serious and/or unstable pre-existing medical, psychiatric or other condition that, in the treating clinician’s judgement could interfere with patient safety or obtaining informed consent
    18. Has known psychiatric or substance abuse disorders that would interfere with co-operation with the requirements of the trial
    19. Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through to 4 months after the last dose of trial treatment
    20. Has received a live vaccine within 30 days of planned start of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.

    *Testing for Hepatitis and HIV is not required unless mandated by local health authority.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure of the study is progression-free survival (PFS) rate at 6 months from the start of maintenance therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from the start of maintenance therapy (pembrolizumab)
    E.5.2Secondary end point(s)
    • Progression–free survival at 6 months from start of weekly paclitaxel
    • Overall survival (from pembrolizumab and start of paclitaxel)
    • Disease response
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of trial- 2 years from the registration of last patient
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunological and biological studies
    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 concerned3
    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
    LVLs
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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 state28
    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)
    There will be no treatment available after the trial. Participants will be given Pembrolizumab for a maximum of 2 years. 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 decisions, 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 Decision2018-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-19
    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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