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    Summary
    EudraCT Number:2016-001794-32
    Sponsor's Protocol Code Number:UC-0130/1619
    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:2016-11-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-001794-32
    A.3Full title of the trial
    A Phase II, Multicenter, Non Randomized, Open Label Study of Nivolumab In Recurrent and/or Metastatic Salivary Gland Carcinoma of the Head and Neck.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.3.2Name or abbreviated title of the trial where available
    NISCAHN
    A.4.1Sponsor's protocol code numberUC-0130/1619
    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 supportLaboratoire BMS
    B.4.2CountryFrance
    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 pointPascaline AUCOUTURIER
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number06.79.35.54.33
    B.5.5Fax number01.71.93.61.65
    B.5.6E-mailaucouturier-excelya@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 Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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.3.4Pharmaceutical 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 INNNIVOLUMAB
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    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 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
    recurrent and/or metastatic salivary glands carcinoma
    E.1.1.1Medical condition in easily understood language
    salivary glands cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066882
    E.1.2Term Metastatic salivary gland 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
    The primary objective of this study is to evaluate the non progression rate at 6 months.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of nivolumab by measuring Progression Free Survival (PFS), Objective Response Rate (ORR- using RECIST 1.1) and Overall Survival (OS) in all eligible patients .
    - To evaluate Growth tumor rate (RECIST 1.1) before and under treatment in all eligible patients.
    - To assess safety and tolerability of nivolumab, as measured by incidence and severity of AEs (CTCAE v4.03), and specific laboratory abnormalities, in all treated patients and pre-defined sub-groups, and to compare the incidence and severity of adverse events to historical data with nivolumab.
    - To assess Quality of Life (QoL) using QLQ-C30 and QLQ-H&N35 in all treated patients.
    - To identify and evaluate potential biomarkers (correlation with PDL1 expression, infiltration of tumor by T-cells and NK-cells, etc.) of nivolumab in patients with recurrent or metastatic Salivary Glands Carcinoma, not eligible to local treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Adult men and women ≥ 18 years
    2) Histologically confirmed carcinoma of the salivary glands, recurrent or metastatic (adenoid cystic carcinoma or non-adenoid cystic carcinoma) not eligible to local treatment
    3) Pre-treatment tumor tissue available for central review and biomarkers analysis.
    4) At least one measurable lesion ≥ 10 mm (outside any previous irradiated field) according to RECIST 1.1 criteria with MRI or CT-scan
    5) Patients with confirmed disease progression at study entry. The ”baseline” radiological evaluation (either MRI or CT scan) should demonstrate disease progression by RECIST 1.1 when compared to a prior disease assessment done within a 6 months period prior to screening.
    6) Previous anti-cancer therapies must be discontinued at least 4 weeks prior to administration of study drug. Concomitant, palliative (limited-field) radiation therapy is permitted during the study, if all of the following criteria are met:
    - Repeated imaging demonstrates no new sites of bone metastases.
    - The lesion being considered for palliative radiation is not a target lesion.
    7) Performance status ECOG < 2
    8) Screening laboratory values must meet the following criteria and should be obtained within 7 days prior to starting study drug: WBC ≥ 2000/mm3, Neutrophils ≥ 1500/mm3, Platelets ≥ 100 000 /mm3, Hemoglobin > 9.0 g/dL, Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (using the Cockcroft-Gault formula), AST/ALT/PAL ≤ 3 x ULN or ≤ 5 x ULN when liver metastases, Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
    9) Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
    10) Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab
    11) Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
    12) Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception).
    13) Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
    14) Patients with social insurance coverage.
    E.4Principal exclusion criteria
    1) Stable disease
    2) Symptomatic / active brain metastases.
    3) Immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) within 2 weeks prior to study drug administration. A 2 weeks wash-out minimum is required before starting study drug.
    4) Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
    5) Patients with any active or suspected autoimmune disease or an history of known autoimmune disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are however eligible for this trial).
    6) Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    7) History of organ transplantation requiring long-term immunosuppressive medications
    8) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
    9) Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
    10) Known history or active tuberculosis
    11) Any other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured in situ cancer) unless free of disease for at least three years
    12) History of allergy to study drug components
    13) Any toxicity (other than alopecia) attributed to prior anti-cancer therapy not resolved to grade 1 (NCI CTCAE version 4) at baseline level before administration of study drug.
    14) Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events.
    15) History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake (if applicable).
    16) Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study.
    17) Individuals deprived of liberty or placed under the authority of a tutor.
    18) Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment and during the treatment period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the non-progression rate at 6 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months
    E.5.2Secondary end point(s)
    Efficacy : Progression Free Survival ORR using RECIST 1.1 and OS Growth tumor rate before and under treatment in all eligible patients.
    Safety profile : Toxicities (standard NCI CTC-AE v4.0 scale).
    Quality of Life : QLQ-C30 and QLQ-H&N35 questionnaires.
    Biomarkers : Correlations between expression of molecular targets and efficacy.
    Exploratory : Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST)
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers identification.
    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 No
    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 concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state92
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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