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    Summary
    EudraCT Number:2021-002461-18
    Sponsor's Protocol Code Number:20-214-36
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-002461-18
    A.3Full title of the trial
    A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined with Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients with Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors (PROPEL-36)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bempegaldesleukin with pembrolizumab in patients with PD-L1 (programmed cell death-ligand 1) positive Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma (HNSCC).
    A.4.1Sponsor's protocol code number20-214-36
    A.5.4Other Identifiers
    Name:US IND Nº Number:153938
    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 SponsorNektar Therapeutics
    B.1.3.4CountryUnited States
    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 supportNektar Therapeutics
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportSFJ Pharmaceuticals
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address3900 Paramount Parkway
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560-7200
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1910558 8889
    B.5.6E-mailrhonda.mazur@ppd.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 namebempegaldesleukin (NKTR-214)
    D.3.2Product code bempegaldesleukin (NKTR-214)
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNBEMPEGALDESLEUKIN
    D.3.9.1CAS number 1939126-74-5
    D.3.9.2Current sponsor codeNKTR-214
    D.3.9.3Other descriptive nameBEMPEGALDESLEUKIN
    D.3.9.4EV Substance CodeSUB196365
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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.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 (Pembrolizumab)
    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 nameKeytruda (Pembrolizumab)
    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 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) 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
    Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors
    E.1.1.1Medical condition in easily understood language
    Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082179
    E.1.2Term Squamous cell carcinoma of head and neck metastatic
    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
    1. To compare the overall survival (OS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
    2. To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab
    E.2.2Secondary objectives of the trial
    1. To compare progression-free survival (PFS).
    2. To compare time to deterioration in global health status/quality of life, pain, and swallowing.
    3. To compare mean change from baseline in global health status/quality of life.
    4. To compare the overall safety and tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Provide written, informed consent to participate in the study and follow the study procedures.
    • Male or female patients, age 18 years or older on the day of signing the informed consent form.
    Have histologically or cytologically-confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
    o No prior systemic therapy for recurrent or metastatic disease. Systemic therapy given as part of multimodal treatment for locally advanced disease is allowed if completed more than 6 months prior to signing consent.
    o The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
    o Patients may not have a primary tumor site of nasopharynx (any histology) and/or unknown primary.
    • Have measurable disease based on RECIST 1.1 as determined by the local site Investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions since irradiation.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    • Tumor tissue from a core, incisional, or excisional biopsy (fine needle aspirates are not acceptable) to the central laboratory for determination of PD-L1 status (if not determined at local laboratory) and exploratory biomarker analyses. A newly obtained biopsy is strongly preferred, but archival tumor biopsy may be used and provided (see Section 8.3.1).
    • The tumor must have positive PD-L1 expression (ie, CPS ≥ 1) as determined with the PD-L1 IHC 22C3 PharmDx diagnostic kit at either a local or central laboratory.

    • Patients with oropharyngeal cancer: must have results from testing of HPV status defined as p16 IHC testing using CINtec® p16 Histology assay (Ventana Medical Systems Inc., Tucson AZ). If HPV status was previously tested using this method, no additional testing is required. Note: If local p16 testing results are not available, or cannot be assessed by the specified method, a tumor tissue sample may be submitted to the central laboratory for p16 testing. Patients with oral cavity, hypopharynx, or larynx cancers: HPV testing by p16 IHC is not required as by convention these tumor locations are assumed to be HPV negative.
    E.4Principal exclusion criteria
    • Has disease that is suitable for local therapy administered with curative intent.
    • Has progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
    • Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to initiation of study drug, or patient has not fully recovered (ie, ≤ Grade 1 or at baseline) from AEs due to a previously administered treatment. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease. Note:
    o Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and qualify for the study.
    o If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
    • Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain) as determined by Investigator.
    • Has a known additional malignancy that is progressing or has required active treatment within 5 years prior to the first dose of study drug with the exception of: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer, and curatively resected in situ breast cancer.
    • Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, 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) is not considered a form of systemic treatment and is allowed.
    • 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 study drug. Corticosteroid use as pre-medication for allergic reactions (eg, intravenous [IV] contrast) is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are:
    1. OS, defined as the time from randomization to death due to any cause.
    2. ORR, defined as the rate of confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. OS: time between the date of randomization and the date of death due
    to any cause.
    2. ORR will be tested at a statistical significance level of 0.001 at the second interim analysis.
    E.5.2Secondary end point(s)
    1. PFS, defined as the time from randomization to the first documented disease progression (per RECIST 1.1 by BICR) or death due to any cause, whichever occurs first.
    2. Time from baseline to a ≥ 10-point decrease from baseline with confirmation by the subsequent visit of a ≥ 10-point deterioration from baseline in: • Global health status/quality of life assessment based on the global health status/quality of life scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30). • Pain based on the pain multi-item scales of EORTC QLQ head and neck cancer specific module (EORTC QLQ-H&N35).
    • Swallowing based on the swallowing multi-item scales of EORTC QLQ-H&N353.
    3. Mean change from baseline in global health status/quality of life scales of EORTC QLQ-C30
    4. Safety will be based on assessments of treatment-emergent adverse events (AEs) and serious AEs (SAEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. PFS: from randomization to the first documented disease progression (per RECIST 1.1 by BICR) or death due to any cause, whichever occurs first.
    2. Completed by patients at baseline and throughout the study.
    3. Mean change from baseline in global health status/quality of life scales of EORTC QLQ-C30: completed by patients at baseline and throughout the study.
    4. Safety will be based on assessments of treatment-emergent adverse events (AEs) and serious AEs (SAEs): from the baseline and throughout the 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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    Australia
    Canada
    China
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Singapore
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    United Kingdom
    Czechia
    Greece
    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
    End of study is defined as no more than 5 years after the last patient received their first dose of study drug or Sponsor decision to terminate the study, whichever comes first.
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 500
    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 end of treatment, each patient will be FU for 90 d after the last dose of all study drugs for AE, SAEs & AESI. Patients who discontinue for reasons other than centrally verified disease progression will have post-treatment FU for disease status until disease progression is verified by the central imaging, initiating non-study cancer treatment, WD consent, or becoming lost to FU. All patients will be FU for OS until death, WD consent, is lost to FU, or study is terminated by Sponsor.
    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 Decision2021-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-04-22
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