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    The EU Clinical Trials Register currently displays   43858   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:2015-001123-22
    Sponsor's Protocol Code Number:AIO-TRK-0115
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-04
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2015-001123-22
    A.3Full title of the trial
    A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
    Eine doppelblinde, randomisierte, Placebo-kontrollierte Phase II Studie zur Untersuchung einer Erhaltungstherapie durch Pembrolizumab nach einer platinbasierten Erstlinientherapie bei Patienten mit metastasierten, nicht-kleinzelligen Plattenepithelkarzinom der Lunge
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
    Studie zur Untersuchung einer Erhaltungstherapie durch Pembrolizumab nach einer platinbasierten Erstlinientherapie bei Patienten mit metastasierten, nicht-kleinzelligen Plattenepithelkarzinom der Lunge
    A.3.2Name or abbreviated title of the trial where available
    PRIMUS
    A.4.1Sponsor's protocol code numberAIO-TRK-0115
    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 SponsorAIO-Studien-gGmbH
    B.1.3.4CountryGermany
    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 supportMSD SHARP & DOHME GMBH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAIO-Studien-gGmbH
    B.5.2Functional name of contact pointAIO-Studien-gGmbH
    B.5.3 Address:
    B.5.3.1Street AddressKuno-Fischer-Str. 8
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14057
    B.5.3.4CountryGermany
    B.5.4Telephone number4930 8145 34431
    B.5.5Fax number49303229 32926
    B.5.6E-mailinfo@aio-studien-ggmbh.de
    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 Yes
    D.2.1.1.1Trade name 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
    D.3.2Product code 1374853-91-4
    D.3.4Pharmaceutical form Lyophilisate 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 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 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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with stage IV metastatic squamous non-small cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Patients with metastatic squamous non-small-cell lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 the efficacy of Pembrolizumab vs. placebo in terms of progression-free survival in patients with metastatic squamous, non-small cell lung cancer.
    E.2.2Secondary objectives of the trial
    To evaluate tumor response, survival, tolerability and safety as well as quality of life of patients receiving Pembrolizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patient, age ≥ 18 years
    2.Signed informed consent
    3.Ability to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations
    4.Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
    5.At least one measurable tumor lesion according to RECIST 1.1
    6.Histologically or cytologically confirmed diagnosis of stage IV (AJCC Version 7) squamous non-small cell lung carcinoma
    7.Complete response, partial response or stable disease after at least 2 cycles of first-line chemotherapy with cisplatin or carboplatin
    8.Last administration of platinum based first-line chemotherapy ≥3 weeks and ≤ 8 weeks prior first dose of study treatment
    9.Tumor specimen available for central PD-L1 testing. Tumor specimen must be a tumor block not a pre-cut slides.
    10.Adequate bone-marrow and organ function:
    a.Absolute neutrophil count ≥ 1.5 x 109/L and
    b.Thrombocytes ≥ 100 x 109/L and
    c.Hemoglobin ≥ 9 g/dL
    d.INR ≤ 1.5 und PTT ≤ 1.5 x upper limit during the last 7 days before therapy
    e.Bilirubin < 1.5 x lower limit and
    f.GOT and GPT < 3 x lower limit (5 x lower limit in case of liver metastases)
    g.Creatinine ≤ 1.5 x upper limit or creatinine clearance ≥ 45 ml/min (after first line chemotherapy)
    11.In female patients of childbearing potential (i.e. did not undergo surgical sterilization – hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and is not post-menopausal for at least 24 consecutive months), a negative pregnancy test at screening
    12.Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use 2 adequate barrier methods of contraception during study treatment and for 120 days after last administration of study drug
    E.4Principal exclusion criteria
    1.Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to treatment start. It is permissable that a patient participates in a follow-up phase of any previous study.
    2.Patient received systemic steroid therapy within three days prior to the first dose of study treatment (however an upper limit 10mg prednisolone or prednisolone equivalent is acceptable) or received any other form of immunosuppressive medication
    3.History of allogeneic tissue/solid organ transplant
    4.History of pneumonitis or interstitial lung disease that has required oral or i.v. steroids
    5.Radiotherapy of target lesion ≤ 28 days prior first dose of study treatment
    6.Major surgery ≤ 28 days prior first dose of study treatment
    7.Minor surgery (e.g. venous catheter) ≤ 24 hours prior first dose of study treatment
    8.Cardiovascular or cerebrovascular disease of clinical relevance: e.g. acute myocardial infarction or stroke during the last 6 months, unstable angina, relevant and unstable dysrhythmia (controlled TAA allowed).
    9.Severe wound healing disorders, active ulcus ventriculi/duodenal ulcer, bone fracture
    10.Known active HBV, HCV or HIV infection
    11.Has any other active infection requiring systemic therapy.
    12.Patients with active tuberculosis
    13.Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
    14.Female patient pregnant or breastfeeding, or expecting to conceive or father children during the study and through 120 days after last administration of study drug
    15.Indications of a neurological or other disease, which may influence the feasibility of the study or may seriously disturb tolerability
    16.A diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 3 days prior to the first dose of trial treatment.
    17.Patient has had a prior monoclonal antibody, which does significantly interfere with the immune system or which does have a systemic therapeutic impact on the tumor within 4 weeks prior to study Day 1.
    18.Patient has not recovered (i.e., ≤ Grade 1 or at baseline) from side effects due to agents administered more than 4 weeks earlier. [Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.]
    19.Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    20.Has an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study.
    21.Has received a live vaccine within 30 days prior to the first dose of trial treatment.
    22.Has known hypersensitivity to pembrolizumab or any of its insipients.
    23.Patient who has be incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is progression-free survival according to RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment phase: every 6 weeks
    If tumor progression or non-tolerable toxicity is noted the patient will enter the follow-up phase.
    During Follow up phase: every 8 weeks (+/- 14 days)
    E.5.2Secondary end point(s)
    The secondary endpoints of this study include:
    •Overall response rate
    •Overall survival
    •PD-L1 expression in tumor samples
    •Tolerability and safety
    •Quality of life (FACT-L, LCSS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After treatment discontinuation, follow-up evaluations (FU visits or phone calls) will be performed every 8 weeks (+/- 14 days) in order to collect information on survival status and subsequent cancer treatment until end of study.
    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 Yes
    E.6.13.1Other scope of the trial description
    translational research
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned16
    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 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
    The study will be terminated as soon as the necessary number of events have been observed or after the last patient has completed at least 10 months follow-up.
    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 months11
    E.8.9.1In the Member State concerned 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.1.3Elderly (>=65 years) Yes
    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 state130
    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)
    All patients will be treated according to the current therapeutic standard. Decisions for further therapies will be done by the treating physician in agreement with patient.
    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 Decision2015-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-24
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