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    Summary
    EudraCT Number:2019-002263-99
    Sponsor's Protocol Code Number:209229
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-15
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2019-002263-99
    A.3Full title of the trial
    A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II/III study of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo in participants with recurrent or metastatic head and neck cancer
    A.4.1Sponsor's protocol code number209229
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0208 990 4466
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 nameGSK3359609
    D.3.2Product code GSK3359609
    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 INNN/A
    D.3.9.1CAS number 2252518-85-5
    D.3.9.2Current sponsor codeGSK3359609
    D.3.9.3Other descriptive nameGSK3359609
    D.3.9.4EV Substance CodeSUB181939
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized, engineered IgG4 monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 B.V.
    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 MK-3475
    D.3.4Pharmaceutical form Concentrate 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.3.9.4EV 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 Yes
    D.3.11.13.1Other medicinal product typePembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region).
    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
    Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
    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 LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the efficacy of GSK3359609 in combination with pembrolizumab to pembrolizumab plus placebo in the
    Programmed Death Ligand 1 (PD L1) expression positive (CPS ≥ 1) population and in the PD-L1 expression high (CPS ≥20) population

    E.2.2Secondary objectives of the trial
    -Further compare the efficacy of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo

    -Evaluate the safety and tolerability of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo

    -Evaluate and compare disease related symptoms and impact on function and health-related quality of life (HRQoL) of GSK3359609/pembrolizumab versus pembrolizumab plus placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study if all of the following criteria apply:

    1. Capable of giving signed informed consent

    2. Male or female, age ≥18 years at the time consent is obtained (minimum age requirement per local regulatory requirements)

    3. Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma (HNSCC) that was diagnosed as recurrent or metastatic and considered incurable by local therapies

    4. Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.

    5. No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease, and no disease progression/recurrence within 6 months of the completion of systemic treatment with curative intent)

    6. Measurable disease per RECIST version 1.1 guidelines

    7. ECOG Performance PS score of 0 or 1

    8. Adequate organ function

    9. Life expectancy of at least 12 weeks

    10. Female participants: must not be pregnant, not breastfeeding, and at least one of the following conditions apply:
    a. Not a woman of childbearing potential (WOCBP)
    b. A WOCBP who agrees to use a method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment.

    11. Male participants with female partners of child-bearing potential: must agree to use a highly effective contraception while receiving study treatment and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.

    12. Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone biopsies are not acceptable) acquired within 2 years prior to date of PD-L1 immunohistochemistry (IHC) testing by central laboratory.

    13. Have PD-L1 IHC CPS ≥1 status by central laboratory testing

    14. Have results from testing of HPV status for oropharyngeal cancer
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:

    1. Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
    2. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter.
    3.Has high risk of bleeding (examples include but not limited to tumors encasing or infiltrating a major vessel [i.e. carotid, jugular, bronchial artery) and/or exhibits other high-risk features such as an arteriovenous fistula)
    NOTE: Principal investigator should consult the GSK Medical Monitors to confirm eligibility of patients with disease features that may confer a high risk of tumor associated hemorrhage.
    4.Active tumor bleeding
    5.Grade 3 or Grade 4 hypercalcemia
    6.Major surgery ≤28 days prior to randomization.
    7. Toxicity from previous anticancer treatment that includes toxicity related to prior treatment that has not resolved to ≤ Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be ≤ Grade 2)
    8. Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization
    9. Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization
    10.Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below:
    a.Any other invasive malignancy for which the participant was definitively treated, has been disease-free for ≤3 years and in the opinion of the principal investigator and GSK Medical Monitor will not
    affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical study
    b.Curatively treated non-melanoma skin or successfully treated in situ carcinoma
    c.Low-risk early stage prostate cancer
    11. Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years
    12. Has a diagnosis of immunodeficiency or is receiving systemic steroids (≥10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization
    13. Receipt of any live vaccine within 30 days prior randomization
    14. Prior allogeneic/autologous bone marrow or solid organ transplantation
    15. Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents
    16. Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
    17. Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess
    18. Recent history of allergen desensitization therapy within 4 weeks of randomization
    19. History or evidence of cardiac abnormalities within the 6 months prior to randomization
    20. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice.
    21. Active infection requiring systemic therapy
    22.Known HIV infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection
    23. History of severe hypersensitivity to monoclonal antibodies or any ingredient used in the study treatment formulations
    24. Known history of active tuberculosis
    25. Any serious (≥Grade 3) and/or unstable pre-existing medical condition (aside from malignancy)
    26. Any psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
    27. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
    28. Is currently participating in (unless in follow-up phase and 4 weeks have elapsed from last dose of prior investigational agent), or has participated in a study of an investigational agent or has used an
    investigational device within 4 weeks prior to date of randomization
    E.5 End points
    E.5.1Primary end point(s)
    •OS, defined as the time from the date of randomization to the date of death due to any cause
    •PFS per RECIST v1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever comes first
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS: date of randomization to date of death, PFS: date of randomization to date of disease progression per RECISTv1.1 guideline
    E.5.2Secondary end point(s)
    •PFS per iRECIST (iPFS) by investigator assessment in the PD-L1 CPS ≥1 population
    •PFS per RECIST v1.1 and iPFS by investigator assessment in PD-L1 CPS ≥20 population
    •Milestone OS rate at 12 and 24 months in the PD-L1 CPS ≥1 and CPS ≥20 populations
    •ORR per RECIST v1.1 by investigator assessment in the PD-L1 CPS ≥1 and CPS ≥20 populations
    •DCR per RECIST v1.1 by investigator assessment in the PD-L1 CPS ≥1 and CPS ≥20 populations
    •DoR per RECIST v1.1 by investigator assessment in the PD-L1 CPS ≥1 and CPS ≥20 populations
    •Frequency and severity of AEs, AESI, SAEs
    •Dose modifications (i.e., interruptions, discontinuations)
    •The time to deterioration in pain measured by the EORTC QLQ-H&N35 pain domain in the PD-L1 CPS ≥1 and CPS ≥20 populations
    •The time to deterioration in physical function measured by the PROMIS PF 8c in the
    PD-L1 CPS ≥1 and CPS ≥20 populations
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS: date of randomization to date of progression per immune-based PFS; Milestone survival: 12 and 24 months
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Patient Reported Outcomes
    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) Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA129
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    China
    Colombia
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Taiwan
    Thailand
    Turkey
    United States
    Austria
    Denmark
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Norway
    Poland
    Portugal
    Sweden
    United Kingdom
    Netherlands
    Romania
    Spain
    Switzerland
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study including follow-up for survival or until follow-up for survival is no longer required (refer to Section 7.1).
    The end of the study is defined as the date of the last visit of the last participant in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 384
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 216
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 261
    F.4.2.2In the whole clinical trial 600
    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)
    Participants receiving study treatment at the time of the final analysis may continue to receive study treatment until treatment is discontinued as indicated in Section 7.1. Participants who permanently discontinue study treatment will not receive any additional treatment from GSK. The investigator is responsible for ensuring that consideration has been given to the post-study care based on the participant’s medical condition.
    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 Decision2020-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-20
    P. End of Trial
    P.End of Trial StatusOngoing
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