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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-000603-91
    Sponsor's Protocol Code Number:CA013-004
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-28
    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 number2016-000603-91
    A.3Full title of the trial
    A Phase 1/2a Study of BMS-986179 Administered in Combination with Nivolumab (BMS- 936558) in Subjects with Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of BMS-986179 Administered in Combination with Nivolumab (BMS- 936558) in Subjects with Advanced Solid Tumors
    A.4.1Sponsor's protocol code numberCA013-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02754141
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1179-3950
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameNIVOLUMAB - 10ml vial
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection/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.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameBMS-936558, MDX1106, ONO-4538
    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.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 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 nameNIVOLUMAB - 4ml vial
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection/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.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameBMS-936558, MDX1106, ONO-4538
    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.IMP: 3
    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 nameAnti-CD73
    D.3.2Product code BMS-986179
    D.3.4Pharmaceutical form 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 INNAnti CD73
    D.3.9.2Current sponsor codeCA013-004
    D.3.9.3Other descriptive nameBMS986179
    D.3.9.4EV Substance CodeSUB181628
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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
    Solid tumors
    E.1.1.1Medical condition in easily understood language
    Solid tumors
    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 10065252
    E.1.2Term 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
    The primary objective is to assess the safety and tolerability of BMS-986179 administered alone and/or in combination with nivolumab.
    E.2.2Secondary objectives of the trial
    -) To characterize the PD activity of BMS-986179 administered alone and in combination with nivolumab
    -) To assess the preliminary anti-tumor activity of BMS-986179 in combination with nivolumab as measured by objective response rate (ORR), DOR, and progression-free survival rate (PFSR)
    -) To characterize the PK and immunogenicity of BMS-986179 administered alone and in
    combination with nivolumab
    -) To characterize the immunogenicity of nivolumab when administered in combination with
    BMS-986179
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Part 1B is a substudy.
    E.3Principal inclusion criteria
    1. Signed Written IC
    2. Population
    a) Subjects must be > 18 years old/have histologic or cytologic confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease and have at least 1 lesion that is biopsy-accessible.
    b) Part 1A/Part 1B:
    i) Subjects must have received, and then progressed/been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists and have been considered for all other potentially efficacious therapies prior to enrollment. Subjects who are ineligible for standard therapy (due to medical factors) will be allowed to enroll provided their refusal/ineligibility is documented in records.
    ii) All solid tumor histologies will be permitted except for subjects with primary CNS tumors or with CNS metastases as the only site of active disease.
    c) Part 2:
    i) For ovarian cancer
    (1) Subjects must have received and progressed/been intolerant of at least 1 prior platinum-containing treatment regimen and have been considered for all other potentially efficacious therapies.
    (2) Subjects who are sensitive to platinum must have received at least 2 prior platinum-containing lines of treatment.
    ii) For CRC:
    (1) Subjects must have received and progressed/been intolerant of at least 1 standard systemic therapy for metastatic and/or unresectable disease (or have progressed within 6 months of adjuvant therapy) and have been considered for all other potentially efficacious therapies.
    (2) Subjects must have known KRAS mutation status.
    iii) For gastric cancer:
    (1) Subjects must have received and progressed/been intolerant of at least 1 prior standard systemic therapy for metastatic and/or unresectable disease (or have progressed within 6 months of adjuvant therapy) and have been considered for all other potentially efficacious therapies.
    (a) Subjects must have known HER2 mutation status. Subjects with tumors overexpressing HER2 must have received prior HER2 therapy or have a medical reason for ineligibility.
    iv) For pancreatic cancer:
    (1) Subjects must have received and progressed/been intolerant of (or not be a candidate for) at least 1 prior standard therapy and have been considered for all other potentially efficacious therapies.
    d) Subjects must have an Eastern Cooperative Oncology Group performance status of ≤ 1.
    e) Subjects must have at least one lesion with measureable disease
    f) Subjects who have had prior exposure to therapy with any agent specifically targeting checkpoint pathway inhibition are permitted after a washout period of any time > 4 weeks from the last treatment.
    g) Subjects with prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-glucocorticoid induced tumor necrosis factor receptor, anti-CD137, or anti-OX40 antibody, with exceptions, are permitted after a washout period of any time > 4 weeks from the last treatment.
    h) Prior palliative radiotherapy must have been completed at least 2 weeks prior to first dose of the study drug.
    i) Subject must consent to a pre-treatment tumor biopsy. Subjects must also consent to the acquisition of existing formalin-fixed paraffin-embedded tumor tissue (if available), either a block or 15 to 20 unstained slides, for performance of correlative studies.
    j) Pre-treatment biopsy tissue may have been collected at any time during the screening period prior to the first dose of the study drug.
    k) Subjects must have adequate organ function.
    l) Ability to comply with treatment, PK, immunogenicity, biomarker, and PD sample collection, and required study follow-up.
    m) Subject re-enrollment: This study permits the re-enrollment of a subject who has discontinued the study as a pre-treatment failure.

    3. Age and Reproductive Status
    a) Subjects must be males and females ages ≥ 18 years at the time of informed consent.
    b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of the study drug.
    c) Women must not be breastfeeding.
    d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs plus > 5 half-lives of BMS-986179 plus 30 days (for subjects who discontinue during the monotherapy lead-in) or > 5 months after the last dose of nivolumab (for subjects who discontinue during combination therapy).
    e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs plus > 5 half-lives of BMS-986179 plus 90 days (for subjects who discontinue during the monotherapy lead-in) > 7 months after the last dose of nivolumab (for subjects who discontinue during combination therapy).
    f) Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements and still undergo pregnancy testing as described.
    E.4Principal exclusion criteria
    1. Target Disease Exceptions
    a) Subjects with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded. However, subjects with controlled brain metastases will be allowed to enroll.
    b) Subjects with carcinomatous meningitis are excluded.
    c) Subjects who have participated in any prior clinical study with nivolumab in which OS is listed as the primary or co-primary endpoint and which has not completed analysis based on the primary endpoint are excluded.
    d) For pancreatic cancer:
    Subjects with clinically relevant ascites at baseline (defined as requiring paracentesis) or with moderate radiographic ascites are excluded.

    2. Medical History and Concurrent Diseases
    a) Subjects with a prior malignancy, different from the one used for enrollment in this study,
    diagnosed less than 2 years ago are excluded. Subjects with second malignancies diagnosed more than 2 years ago who have received therapy with curative intent with no evidence of disease during the interval and who are considered by the investigator to present a low risk for recurrence will be eligible.
    b) Subjects with other active malignancy requiring concurrent intervention are excluded.
    c) Subjects with prior organ allograft are excluded.
    d) Subjects who have received prior anti-cancer treatments are permitted
    e) Subjects who have received prior therapy with an anti-CD73 antibody, an anti-CD39 antibody, or an adenosine 2A receptor inhibitor are excluded.
    f) Subjects with a prior history of deep vein thrombosis within the last 6 months, or arterial thrombus at any time are excluded.
    g) Subjects with active, known or suspected autoimmune disease, with a few exceptions.
    h) Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity are excluded.
    i) Subjects with chronic obstructive pulmonary disease requiring recurrent steroids bursts or chronic steroids at doses greater than 10 mg/day of prednisone or the equivalent are excluded.
    j) Subjects 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 except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease are excluded. Note: Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating study drug is permitted.
    k) Subjects with uncontrolled or significant cardiovascular disease are excluded.
    l) Subjects with active hepatitis as evidenced by the following are excluded:
    i) Positive test for hepatitis B surface antigen
    ii) Positive test for hepatitis C antibody and/or qualitative viral load
    m) Subjects with evidence of active bacterial, viral, or fungal infections less or equal to 7 days prior to
    initiation of study drug therapy are excluded.
    n) Subjects with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
    o) Subjects with evidence or history of active or latent tuberculosis infection are excluded.
    p) Subjects who have undergone any major surgery within 4 weeks of study drug administration are excluded. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of the study drug.
    q) All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 4.03) or baseline before administration of the study drug.
    r) Subjects who have used non-oncology vaccines containing live virus within 12 weeks prior to study drug are excluded.
    s) Subjects who have used packed red blood cells or received a platelet transfusion within 2 weeks prior to the first dose of the study drug are excluded.
    t) Subjects with a known or underlying medical condition that, in the opinion of the investigator or Sponsor, could make the administration of study drug hazardous to the subjects, or could adversely affect the ability of the subject to comply with or tolerate the study, are excluded.
    3. Allergies to nivolumab and significant reaction to prior anti-cancer immune modulating therapies.
    4. Other Exclusion Criteria
    a) Subjects who are prisoners or are involuntarily incarcerated are excluded.
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness are excluded.
    c) Subjects who are unable to comply with restrictions and prohibited activities/treatments are excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to assess the safety and tolerability of BMS-986179 administered alone and/or in combination with nivolumab. The assessment of safety will be based on the incidence of AEs, SAEs, AEs leading to discontinuation, and deaths. In addition, clinical laboratory test abnormalities will be examined.
    E.5.1.1Timepoint(s) of evaluation of this end point
    see above section
    E.5.2Secondary end point(s)
    The first secondary objective (PD effect of CD73 inhibition) will be measured by CD73 enzyme assays and CD73 IHC in pre- and on-treatment tumor biopsies.
    The anti-tumor activity of BMS-986179 in combination with nivolumab will be measured by ORR, DOR, and PFSR at 24 weeks and will be based on RECIST 1.1 for solid tumors. Disease assessment with CT and/or MRI as appropriate will be performed at baseline, every 8 weeks from the start of combination treatment for the Q1W and Q2W regimens, or every 9 weeks from the start of combination treatment for the Q3W regimen until treatment discontinuation or completion, and then every 12 weeks for the first year until further disease progression, start of a new treatment, lost to follow-up, or death, whichever comes first.
    The PK will be characterized by assessment of PK parameters of BMS-986179, and immunogenicity will be assessed by the frequency of positive ADA to BMS-986179 and nivolumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see above section.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    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.8.2.4Number of treatment arms in the trial13
    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 EEA20
    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
    Israel
    United States
    France
    Germany
    Italy
    Netherlands
    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
    LPLV
    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 days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days11
    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: 163
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 204
    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)
    At the end of the study, BMS will not continue to provide BMS-supplied study drug to subjects/investigators unless BMS chooses to extend the study.
    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 Decision2016-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-12
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