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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-002325-18
    Sponsor's Protocol Code Number:PemDoc
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2015-002325-18
    A.3Full title of the trial
    Immunomodulation of pembrolizumab plus docetaxel for the treatment of r/m SCCHN after platinum failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunomodulation of pembrolizumab plus docetaxel for the treatment of r/m SCCHN after platinum failure
    A.4.1Sponsor's protocol code numberPemDoc
    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 SponsorMed. Univ. Wien
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.4Pharmaceutical 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 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 Yes
    D.2.1.1.1Trade name Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Specialites S.A., 20, Avenue Raymond Aron, 92160 Antony, Frankreich
    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.3.4Pharmaceutical form Powder 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 INNDocetaxel
    D.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB25446
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    head and neck cancer
    E.1.1.1Medical condition in easily understood language
    head and neck cancer
    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
    • To evaluate the Overall Response Rate (CR/PR) rate and Progression
    Free Survival (PFS) in patients treated with pembrolizumab plus
    docetaxel for recurrent or metastatic (R/M) HNSCC after platinum-based
    first-line therapy
    • To evaluate the safety of pembrolizumab in combination with
    docetaxel in subjects diagnosed with R/M HNSCC
    E.2.2Secondary objectives of the trial
    • To describe Best Overall Response categories (CR, PR, SD, PD) in
    patients treated with pembrolizumab in combination with docetaxel in
    subjects diagnosed with R/M HNSCC after platinum-based first-line
    therapy
    • To describe individual duration of response over time
    • To evaluate changes in health-related quality-of-life assessments
    from baseline in subjects with R/M HNSCC using the EORTC QLQ C-30
    and EORTC QLQ-H&N35.
    • To assess median Overall Survival (OS) in this patient population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has provided written informed consent prior to any studyrelated
    procedure.
    • The patient is at least 18 years of age
    • Histologically proven locally advanced unresectable, recurrent and/or
    metastatic squamous cell carcinoma of the oropharynx, hypopharynx,
    larynx or oral cavity not amenable for salvage surgery
    • P16 status has to be determined
    • Documented progressive disease based on investigator assessment
    according to RECIST 1.1, following receipt of a cisplatin and/or
    carboplatin based regimen administered for recurrent and/or metastatic
    disease independent of whether patient progressed during or after
    platinum based therapy. Platinum therapy might have been administered either as part of induction chemotherapy (6 months), chemoradiation (6
    months) or as first line systemic palliative chemotherapy (12 months).
    • Measurable disease according to RECIST 1.1.
    • The patient has a life expectancy of at least 3 months.
    • Has a performance status of 0 or 1 on the ECOG Performance Scale
    E.4Principal exclusion criteria
    • Prior taxane therapy is not allowed except as part of induction
    therapy (at least 6 months before study entry)
    • Nasopharyngeal carcinomas or salivary glands cancers are not
    eligible
    • Is currently participating and receiving 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.
    • 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 a known history of active TB (Bacillus Tuberculosis)
    • Hypersensitivity to pembrolizumab or any of its excipients.
    • Has had a prior anti-cancer monoclonal antibody (mAb) within 4
    weeks prior to study 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.
    • 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 adverse events due to a
    previously administered agent.
    - Note: If subject received major surgery, they must have recovered
    adequately from the toxicity and/or complications from the intervention prior to starting therapy.
    • 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 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 imaging for at least four weeks prior to the first dose
    of trial treatment and any neurologic symptoms have returned to
    baseline), have no evidence of new or enlarging brain metastases, and
    are not using steroids for at least 7 days prior to trial treatment. This
    exception does not include carcinomatous meningitis which is excluded
    regardless of clinical stability.
    • Has 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 (eg.,
    thyroxine, insulin, or physiologic corticosteroid replacement therapy for
    adrenal or pituitary insufficiency, etc.) is not considered a form of
    systemic treatment.
    • Has known history of, or any evidence of active, non-infectious
    pneumonitis.
    • Has an active infection requiring systemic 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 known psychiatric or substance abuse disorders that would
    interfere with cooperation with the requirements of the trial.
    • Is pregnant or breastfeeding, or expecting to conceive or father
    children within the projected duration of the trial, starting with the prescreening
    or screening visit through 120 days after the last dose of trial
    treatment.
    • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2
    agent.
    • 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 received a live vaccine within 30 days of planned start of study
    therapy.
    E.5 End points
    E.5.1Primary end point(s)
    - safety
    - response assessment
    - response duration
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 24 month
    E.5.2Secondary end point(s)
    none
    E.5.2.1Timepoint(s) of evaluation of this end point
    na
    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 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 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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: 11
    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 Yes
    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 state21
    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)
    none
    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 Decision2016-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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