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    Summary
    EudraCT Number:2018-000254-21
    Sponsor's Protocol Code Number:MO39839
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-000254-21
    A.3Full title of the trial
    Window of opportunity study of preoperative immunotherapy with atezolizumab (Tecentriq®) with or without tocilizumab (Actemra®) in local head and neck squamous cell carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PIONEER is a clinical study in patients with squamous cell carcinoma of the head and neck that is amenable to surgical resection with curative intent. This study will determine the feasibility of preoperative immunotherapy with atezolizumab (Tecentriq®) with or without tocilizumab (Actemra®)
    A.3.2Name or abbreviated title of the trial where available
    PIONEER
    A.4.1Sponsor's protocol code numberMO39839
    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 Hospital Essen
    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 supportHoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsmedizin Essen - Studienzentrum GmbH
    B.5.2Functional name of contact pointStudy Coordination
    B.5.3 Address:
    B.5.3.1Street AddressHufelandstr. 55
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45147
    B.5.3.4CountryGermany
    B.5.4Telephone number+49020172377411
    B.5.5Fax number+4902017239477411
    B.5.6E-mailume-studienzentrum@uk-essen.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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderHoffmann-La Roche Ltd
    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 nameAtezolizumab
    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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.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 Actemra
    D.2.1.1.2Name of the Marketing Authorisation holderF. Hoffmann-La Roche LTD
    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 nametocilizumab
    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.3.11 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
    local squamous cell carcinoma of the head and neck
    E.1.1.1Medical condition in easily understood language
    local squamous cell carcinoma of the head and neck
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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 10067821
    E.1.2Term Head and neck 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
    • Effect of atezolizumab with or without tocilizumab on tumorinfiltrating
    immune cells in resectable SCCHN
    • Feasibility of preoperative short time immunotherapy
    E.2.2Secondary objectives of the trial
    • Safety of preoperative short time immunotherapy and assessment of postoperative complication rates
    • To assess dynamics in tumor immunity
    • Exploratory analyses of predictive biomarker by gene and protein expression to establish correlation with pathological response
    • Characterization of changes in frequency and numbers of circulating immune cells
    • Resectability after immunotherapy
    • Influence of immunotherapy on histo-morphological assessment
    • (optional) set up of a registry for follow up of patients and subsequent documentation of relapse free survival (RFS) rate and overall survival (OS) rate
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    translational research projects
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. If laboratory or imaging procedures were performed for alternate reasons prior to signing consent, these can be used for screening purposes with consent of the patient. However, all screening examinations and laboratory results must have been obtained within 14 days before first study drug administration (initial tumor imaging: within 28 days before first study drug administration).
    2. Only patients for whom sufficient tumor material to be judged by the local investigator and which is of adequate quality can be included into the trial. Please refer to section 6.5 for further details on quantity and quality of tumor samples.
    3. Histologically or cytologically proven SCCHN (cT1-4a, cN0-3, cM0) that is amenable to surgical resection with curative intent based on the decision of the local multidisciplinary tumorboard.
    4. Patients with relapse after primary radio(chemo)-therapy are allowed if a salvage surgery is possible (maximum 20%). Patients should have recovered from the effects of radiation: AE/sequelae should resolves to ≤ grade 2 (no minimum recovery period required).
    5. Male or female, 18 years of age or older on day of signing informed consent
    6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
    7. Life expectancy >12 weeks
    8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
    • Absolute neutrophil count (ANC) ≥ 1.5E9/L without granulocyte colony-stimulating factor support
    • Lymphocyte count ≥ 0.5E9/L
    • Platelet Count ≥ 100E9/L without transfusion
    • Hemoglobin ≥ 90 g/L
    o Patients may be transfused to meet this criterion but patients in need of chronic or repeated RBC transfusion should be discussed with the sponsor before.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN)
    • Serum bilirubin ≤ 1.5 × ULN with the following exception:
    o Patients with known Gilbert disease: direct serum bilirubin level ≤ ULN for patients with total bilirubin Levels > 1.5 ULN.
    • Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 30 mL/min (calculated using the Cockcroft-Gault formula)
    • Serum Albumin ≥ 2.5 g/dL
    • International normalized ratio (INR) or activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low−molecular weight heparin or warfarin) should be on a stable dose
    9. Women of childbearing potential:
    • Should have a negative urine or serum pregnancy test within 14 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    • Agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after last study drug administration
    • A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
    • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. For men: with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 5 months after the last dose of immunotherapy to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
    E.4Principal exclusion criteria
    1. Evidence of metastatic disease (M1)
    2. cT4b Stage
    3. Prior treatment with immune checkpoint blockade therapies,
    4. Treatment with investigational therapy within 28 days prior to initiation of study treatment
    5. Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 4 weeks prior to initiation of study treatment
    6. Bilateral pleural effusion
    7. Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1.
    8. Treatment with a live-attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study, and for 5 months after the last dose of atezolizumab with or without tocilizumab
    9. Treatment with systemic immuno-stimulatory agents within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment
    10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    11. Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment
    12. Uncontrolled hypercalcemia
    13. Uncontrolled tumor-related pain.
    14. Uncontrolled diabetes mellitus
    15. Pregnant and lactating women
    16. Acute toxicities from previous therapy that have not resolved to Grade ≤ 1, except for alopecia
    17. Infections
    a. Positive human immunodeficiency virus (HIV) test: Known HIV+ patients may be included
    b. Active hepatitis B virus (HBV) infection (chronic or acute), positive HBsAg test at screening
    Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening followed by a negative HBV DNA test, are eligible for the study. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
    c. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening.
    The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
    d. Active tuberculosis
    e. Severe infection within 4 weeks prior to initiation of study treatment
    f. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
    g. Patients receiving prophylactic antibiotics are eligible for the study.
    h. History of frequent severe diverticulitis.
    18. Active or history of autoimmune disease or immune deficiency with the following exceptions:
    - Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study
    - Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
    - Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible
    19. Adverse events (AE) related to any previous radiotherapy, chemotherapy, targeted therapy or surgical procedure that have not reolved to Grade ≤1, except alopecia (any grade) and Grade 2 neuropathy
    20. Prior allogeneic stem cell or solid organ transplantation
    21. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computer tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
    22. Active malignancy or a prior malignancy within the past 3 years. Patients with completely resected basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and patients with isolated elevation in prostate-specific antigen in the absence of radiographic evidence of metastatic prostate cancer are eligible for the study.
    23. Any Grade ≥ 3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1
    24. Increased corrected QT (QTc) interval (QTc > 470 ms)
    25. Family history of long QT syndrome or other risk factors for torsades de pointes
    26. History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1
    27. Significant cardiovascular disease
    28. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
    29. Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety
    30. Participation in another clinical study within the last 3 months prior to inclusion or simultaneous participation in other clinical studies with an exception of studies evaluating radiological imaging.
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage of patients with at least 2-fold increase of GzmB+/CD8+ T cells by immunohistochemistry (IHC) after 1 administration of atezolizumab with or without tocilizumab between pre-treatment biopsy specimens and post-treatment resection specimens
    • Number of patients with completion of pre-operative immunotherapy and resection of SCCHN
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analyses are based on pre- vs. post-treatment comparisons.
    An interim safety analysis is planned after 6 patients in each arm have been treated and undergone resection.
    An second interim safety analysis will be done if surgery is delayed for 3 weeks in the first 3 treated patients in each arm. The reasons for delay and the toxicity of the pre-operative immunotherapy will be critically reviewed by the SSMB. During this analysis the enrollment of further patients will be temprorally paused.
    E.5.2Secondary end point(s)
    1. Assess effects of therapy on tumor-infiltrating immune cells, tumor tissue gene expression signatures, targeted pathways and blood immune cells by analysis of pre-treatment samples (biopsy and blood) versus tumor resection sample (tumor sample and blood). If available, blood and tumor material obtained at relapse will also be analyzed. Following variables will be assessed in each arm:
    1. Safety of preoperative short time immunotherapy and assessment of postoperative complication rates
    2. Safety and tolerability of preoperative immunotherapy
    3. Safety of preoperative short time immunotherapy and assessment of postoperative complication rates
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analyses are based on pre- vs. post-treatment comparisons.
    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: Assess effects of therapy on tumor-infiltrating immune cells, tumor tissue gene expression signatures, targeted pathways and blood immune cells by analysis of pre-treatment samples (biopsy and blood) versus tumor resection sample (tumor sample and blood). If available, blood and tumor material obtained at relapse will also be analyzed.
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 years3
    E.8.9.1In the Member State concerned months8
    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 months8
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-03-14
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