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    Summary
    EudraCT Number:2019-004052-11
    Sponsor's Protocol Code Number:UC-HNG/1909
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-004052-11
    A.3Full title of the trial
    A phase II trial assessing Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in a pre-operative setting for resectable and untreated 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 trial assessing Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in a pre-operative setting for resectable and untreated head and neck squamous cell carcinoma
    A.3.2Name or abbreviated title of the trial where available
    ICING
    A.4.1Sponsor's protocol code numberUC-HNG/1909
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportMerck Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointClotilde SIMON
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number+33173 79 79 11
    B.5.5Fax number+33171 93 61 65
    B.5.6E-mailc-simon@unicancer.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameBintrafusp alfa
    D.3.2Product code M7824
    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 INNBINTRAFUSP ALFA
    D.3.9.1CAS number 1918149-01
    D.3.9.4EV Substance CodeSUB193581
    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) 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.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
    Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.
    E.1.1.1Medical condition in easily understood language
    -
    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 LLT
    E.1.2Classification code 10041824
    E.1.2Term Squamous cell carcinoma of esophagus
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041859
    E.1.2Term Squamous cell carcinoma of the oral cavity stage 0
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041860
    E.1.2Term Squamous cell carcinoma of the oral cavity stage I
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041861
    E.1.2Term Squamous cell carcinoma of the oral cavity stage II
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041862
    E.1.2Term Squamous cell carcinoma of the oral cavity stage III
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041863
    E.1.2Term Squamous cell carcinoma of the oral cavity 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 LLT
    E.1.2Classification code 10031113
    E.1.2Term Oropharyngeal squamous cell carcinoma recurrent
    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 LLT
    E.1.2Classification code 10031114
    E.1.2Term Oropharyngeal squamous cell carcinoma stage 0
    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 LLT
    E.1.2Classification code 10031115
    E.1.2Term Oropharyngeal squamous cell carcinoma stage I
    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 LLT
    E.1.2Classification code 10021052
    E.1.2Term Hypopharyngeal squamous cell carcinoma recurrent
    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 LLT
    E.1.2Classification code 10021053
    E.1.2Term Hypopharyngeal squamous cell carcinoma stage 0
    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 LLT
    E.1.2Classification code 10021055
    E.1.2Term Hypopharyngeal squamous cell carcinoma stage II
    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 LLT
    E.1.2Classification code 10021054
    E.1.2Term Hypopharyngeal squamous cell carcinoma stage I
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041854
    E.1.2Term Squamous cell carcinoma of the hypopharynx stage III
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041853
    E.1.2Term Squamous cell carcinoma of the hypopharynx stage II
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041855
    E.1.2Term Squamous cell carcinoma of the hypopharynx 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 21.0
    E.1.2Level PT
    E.1.2Classification code 10023856
    E.1.2Term Laryngeal squamous cell carcinoma
    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 evaluate the efficacy of bintrafusp alfa, measured by pathological response (PathR), given in a pre-operative setting.
    E.2.2Secondary objectives of the trial
    1/To evaluate the efficacy of bintrafusp alfa by alternative outputs:
    a)The pathological response, using alternative threshold of tumor cell death as compared to the one used for primary objective
    b)The response rate, using primary endpoint criteria, by PD-L1 status.
    c)The response rate, using primary endpoint criteria, by HPV status in cohort A.
    d)The clinical response, as measured by to RECIST v1.1.
    e)Assessment of disease-free survival (DFS), overall survival (OS), loco-regional disease-free survival (LR-DFS), distant disease-free survival (D-DFS) rates at 12, 18, 24 and 36 months after the surgery.
    2/To evaluate the safety and tolerability profile of bintrafusp alfa
    3/To evaluate the impact of inking the tumor margins during baseline endoscopy to avoid surgical plan changes putatively induced by tumor shrinking under therapy.
    EXPLORATORY OBJECTIVE:
    To evaluate the pharmacodynamics value of potential biomarkers comparing pre and post-treatment blood and tumor samples
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥18 years
    2.Patients must have signed a written informed consent form prior to any trial specific procedures
    3.Histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of HNSCC of occult primary could not be enrolled.
    In order to avoid repeated biopsies procedures under general anesthesia, patients with clinically highly suspected squamous cell carcinoma could be registered before the histological or cytological proof. In these cases, the diagnosis will be confirmed rapidly after the endoscopy, either by using frozen sections or by reporting the results obtained on FFPE within no more than 5 working days.
    4.Absence of distant metastases determined by CT scan or Pet CT that must be performed within 35 days prior to endoscopy.
    5.According to the 7th edition AJCC eligible stages are as follow:
    •T2N1, T2N2, T2N3
    •T3 or T4 (any N)
    6.Baseline radiology studies evaluating primary tumor (MRI or CT scan) must be performed within 28 days prior to endoscopy.
    7.Patients must have at least 1 lesion superior to 2 cm in larger axis
    8.ECOG performance status ≤1
    9.Adequate organ and marrow function as defined by the following laboratory results obtained within 28 days prior to the baseline endoscopy:
    a)Hemoglobin (Hb) ≥9,0 g/dL;
    b)Absolute neutrophil count (ANC) ≥1,500/mm3;
    c)Platelet count ≥100,000/mm3;
    d)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × institutional upper limit of normal (ULN);
    e)Total bilirubin ≤1.5 × ULN;
    f)Creatinine clearance >30 mL/min as determined by the Cockcroft-Gault equation (Cockcroft and Gault, 1976)
    10.Negative serology for hepatitis B and C
    11.Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
    12.Willing and able to provide tumor specimen and blood samples for translational research.
    13.Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment.
    14.Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 2 months after last dose of study drugs.
    15.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    16.Patients must be affiliated to the social security system or equivalent
    E.4Principal exclusion criteria
    1.Primary site of head and neck carcinoma in nasopharynx, sinuses, or skin
    2.Patients receiving other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) or other investigational agent within 6 months prior to the first dose of study drug and while on study treatment.
    3.Patients receiving other anti-cancer non-drug therapies: radiation, or tumor embolization within 6 months prior to the first dose of study drug and while on study treatment.
    4.Previous or concurrent cancer within 2 years prior to study inclusion, with the exception of the following cancer types: in situ carcinomas of any location; skin basal cell carcinoma or squamous cell carcinoma stage T1N0M0 or T2N0M0
    5.Any previous treatment with a PD-1, PD-L1 agent
    6.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, active bleeding diatheses.
    7.Current or prior use of immunosuppressive medication within 28 days before the first dose of bintrafusp alfa, with the exceptions of intranasal, intraocular and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
    8.Receipt of live attenuated vaccination within 30 days prior to the first administration of bintrafusp alfa
    9.Active or prior documented autoimmune disease within the past 2 years.
    NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) can be enrolled
    10.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
    11.History of primary immunodeficiency
    12.History of allogenic organ transplant that requires the use of immunosuppressive drugs
    13.Pregnant or breast-feeding women
    14.Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
    15.Known positive HIV status
    16.Participation in another clinical study with an investigational product during the last 30 days.
    17.Known hypersensitivity to the study drug, study drug classes, or study drug excipients.
    18.Patients under guardianship or deprived of his liberty by a judicial or administrative decision or any condition (e.g., psychiatric illness/social/familial/geographical condition) that would limit compliance with study requirement or compromise the ability of the patients to give written informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Rate of pathological response defined as tumor necrosis and/or giant cell/histolytic reaction to keratinous debris in ≥10% of tumor area.
    The measurement of pathological response will be performed under the responsibility of one pathologist per center as soon as the last patient has undergone his surgery (within 1 month).
    E.5.1.1Timepoint(s) of evaluation of this end point
    10% of tumor area
    E.5.2Secondary end point(s)
    The pathological response, using a threshold of 50% (PathR50), 70% (PathR70) and 90% (PathR90): will be considered as responders, the patients presenting 50% or more, 70% or more and 90% or more of tumor necrosis and/or giant cell/histolytic reaction to keratinous debris.
    b)The response rate, using primary endpoint criteria, by PD-L1 status using Combined Positive Score (CPS) thresholds of 1 and 20. CPS is the number of PD-L1 staining cells (tumor cells and immune cells) divided by the total number of viable tumor cells, multiplied by 100. Pre-treatment tissue specimens will be tested for PD-L1 expression and patients will be categorized as:
    oCPS <1: No PD-L1 expression
    oCPS ≥1: PD-L1 expression. Among this second group, patients will be further classified as ≥1CPS <20: Low PD-L1 expression and CPS ≥20: High PD-L1 expression.
    c)The response rate, using primary endpoint criteria, by HPV status defined by p16 staining in cohort A. Two categories will be defined: HPV- and HPV+ ( smokers ≥20 PY). HPV+ non-smoker or smoker <20 PY will be included in cohort B.
    d) The clinical response according to RECIST v1.1 on CT or MRI (same imaging than as baseline).
    e)Assessment of DFS, OS, LR-DFS, and D-DFS rates at 12, 18, 24 and 36 months after the surgery.

    2)Evaluation of safety profile of bintrafusp alfa using the common toxicity criteria from the National Cancer Institute - Common terminology criteria for adverse events version 5.0 (NCI-CTCAE v5.0)
    3)Evaluation of the impact of inking the tumor margins during baseline endoscopy in avoiding surgical plan changes putatively induced by tumor shrinking under therapy assessed by surgeon questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    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.8.3 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 concerned15
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state59
    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)
    Standard post-operative care and standard adjuvant therapy if recommended, including subsequent medical visits and imaging as per standard of care
    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 Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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