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    Summary
    EudraCT Number:2016-000706-12
    Sponsor's Protocol Code Number:SUNNIFORECAST
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-04-03
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2016-000706-12
    A.3Full title of the trial
    A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma
    Randomizovaná otevřená studie fáze 2 Nivolumabu kombinovaného s Ipilimumabem v porovnání se standardní léčbou u subjektů s nikdy neléčeným pokročilým (neoperovatelným či metastazujícím) nesvětlobuněčným karcinomem ledvin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma
    Randomizovaná otevřená studie fáze 2 Nivolumabu kombinovaného s Ipilimumabem v porovnání se standardní léčbou u subjektů s nikdy neléčeným pokročilým (neoperovatelným či metastazujícím) nesvětlobuněčným karcinomem ledvin
    A.3.2Name or abbreviated title of the trial where available
    SUNNIFORECAST
    A.4.1Sponsor's protocol code numberSUNNIFORECAST
    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 SponsorGoethe University Frankfurt
    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 supportGoethe University Frankfurt
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBristol-Myers Squibb
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGoethe Univeristy Frankfurt
    B.5.2Functional name of contact pointDr. Nicola Gökbuget
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number00496963016366
    B.5.5Fax number00496963017463
    B.5.6E-mailgoekbuget@em.uni-frankfurt.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 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.3.1Product nameNivolumab
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibodies
    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 YERVOY
    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.3.1Product nameIpilimumab
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibodies
    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
    To compare the of OS rate at 12 months of Nivolumab combined with Ipilimumab to
    standard of care in patients with previously untreated and advanced non-clear cell RCC
    E.1.1.1Medical condition in easily understood language
    Survival of patients with kidney cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038415
    E.1.2Term Renal cell carcinoma stage unspecified
    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
    To compare the of OS rate at 12 months of Nivolumab combined with Ipilimumab to
    standard of care in patients with previously untreated and advanced non-clear cell RCC.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to examine if the following is achieved:
    To compare the OS rate at 6 and 18 months of Nivolumab combined with Ipilimumab to
    standard of caremonotherapy in previously untreated and advanced non-clear cell RCC
     Duration of reponse (DOR) for both arms and subgroups
     To compare the PFS of Nivolumab combined with Ipilimumab to standard of care with
    previously untreated metastatic non-clear cell RCC
     To compare the medianOS of Nivolumab combined with Ipilimumab to standard of care
    in subjects with previously untreated metastatic non-clear cell RCC C (based on hazard
    ratio)
    To estimate the objective response rate (ORR) of Nivolumab combined with Ipilimumab to standard of care in subjects with previously untreated mRCC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Written Informed Consent

    a) Subjects must have signed and dated an IRB/IEC approved
    written informed consent form in accordance with regulatory and
    institutional guidelines. This must be obtained before the
    performance of any protocol related procedures that are not part
    of normal subject care.

    b) Subjects must be willing and able to comply with scheduled
    visits, treatment schedule, laboratory testing, and other
    requirements of the study.

    2. Target Population

    a) Histological confirmation of non-clear RCC with at least 50%
    non-clear cell component according to actual WHO
    classification36

    b) Advanced (not amenable to curative surgery or radiation therapy)
    or metastatic (AJCC Stage IV) RCC

    c) Karnofsky > 70%

    d) Measurable disease as per RECIST v 1.1 documented by an
    English radiology report

    e) Tumor tissue (FFPE archival or recent acquisition) must be
    available and sent to the central pathological in order to confirm
    the diagnosis. (Note: Fine Needle Aspiration [FNA] and bone
    metastases samples are not acceptable for submission).

    f) Patients with all risk categories will be eligible for the study.
    Patients will be stratified for papillary or non-papillary non-clear
    cell histology and IMDC risk score Patients will be categorized
    according to favorable versus intermediate versus poor risk status
    at registration according to the International Metastatic RCC
    Database Consortium (IMDC) criteria:
    i. KPS equal to 70%
    ii. Less than 1 year from diagnosis to randomization
    iii. Hemoglobin less than the lower limit of normal (LLN)
    iv. Corrected calcium concentration greater than the upper limit of normal (ULN)
    v. Absolute neutrophil count greater than the ULN
    vi. Platelet count greater than the ULN

    If none of the above factors are present, subjects are only eligible for the
    favorable-risk cohort, if 1-2 factors are present subjects are categorized
    as intermediate risk and > 3 factors as poor risk.
    E.4Principal exclusion criteria
    1. Target Disease Exceptions
    a) Any active brain metastases requiring systemic corticosteroids.
    Baseline imaging of the brain by MRI is required in patients with
    clinical signs of potential CNS involvement within 28 days prior
    to randomization.
    b) Tumors with a clear-cell component of > 50%
    Medical History and Concurrent Diseases
    c) Prior systemic treatment with VEGF or VEGF receptor targeted
    therapy (including, but not limited to, Sunitinib, pazopanib,
    axitinib, tivozanib, and bevacizumab) or prior treatment with an
    mTOR inhibitor or cytokines.
    d) Prior treatment with an 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.
    e) Administration of an immune checkpoint inhibitor as standard of
    care
    f) Any active or recent history of a known or suspected
    autoimmune disease or recent history of a syndrome that required
    systemic corticosteroids (> 10 mg daily prednisone equivalent) or
    immunosuppressive medications except for syndromes which
    would not be expected to recur in the absence of an external
    trigger. Subjects with vitiligo or type I diabetes mellitus or
    residual hypothyroidism due to autoimmune thyroiditis only
    requiring hormone replacement are permitted to enroll.
    g) Any condition requiring systemic treatment with corticosteroids
    (> 10 mg daily prednisone equivalents) or other
    immunosuppressive medications within 14 days prior to first
    dose of study drug. Inhaled steroids and adrenal replacement
    steroid doses > 10 mg daily prednisone equivalents are permitted
    in the absence of active autoimmune disease.
    h) Uncontrolled adrenal insufficiency.
    i) Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial
    fibrillation, or prolongation of the Fridericia corrected QT
    (QTcF) interval defined as > 450 msec for males and > 470 msec
    for females, where QTcF = QT / 3√RR
    j) Poorly controlled hypertension (defined as systolic blood pressure (SBP) of 150 mmHg or diastolic blood pressure
    (DBP) of 90 mmHg), despite antihypertensive therapy.
    k) History of any of the following cardiovascular conditions within
    12 months of enrollment: cardiac angioplasty or stenting,
    myocardial infarction, unstable angina, coronary artery by-pass
    graft surgery, symptomatic peripheral vascular disease, class III
    or IV congestive heart failure, as defined by the New York Heart
    Association.
    l) History of cerebrovascular accident including transient ischemic
    attack within the past 12 months.
    m) History of deep vein thrombosis (DVT) unless adequately treated
    with low molecular weight heparin
    n) History of pulmonary embolism within the past 6 months unless
    stable, asymptomatic, and treated with low molecular weight
    heparin for at least 6 weeks.
    o) History of abdominal fistula, gastrointestinal perforation, or
    intra-abdominal abscess within the past 6 months.
    p) Serious, non-healing wound or ulcer.
    q) Evidence of active bleeding or bleeding susceptibility; or
    medically significant hemorrhage within prior 30 days.
    r) Any requirement for anti-coagulation, except for low molecular
    weight heparin.
    s) Prior malignancy active within the previous 3 years except for
    locally curable cancers that have been apparently cured, such as
    basal or squamous cell skin cancer, superficial bladder cancer, or
    carcinoma in situ of the prostate, cervix, or breast.
    t) Known history of testing positive for human immunodeficiency
    virus (HIV) or known acquired immunodeficiency syndrome
    (AIDS).
    u) Any positive test for hepatitis B or hepatitis C virus indicating
    acute or chronic infection.
    v) Known medical condition (eg, a condition associated with
    diarrhea or acute diverticulitis) that, in the investigator’s opinion,
    would increase the risk associated with study participation or
    study drug administration or interfere with the interpretation of
    safety results.
    w) Major surgery (eg, nephrectomy) less than 28 days prior to the
    first dose of study drug.
    x) Anti-cancer therapy less than 28 days prior to the first dose of
    study drug or palliative, focal radiation therapy less than 14 days
    prior to the first dose of study drug.
    y) Receiving concomitant CYP3A4 inducers or strong CYP3A4
    inhibitors
    z) Impairment of gastrointestinal function or gastrointestinal disease
    that may significantly alter the absorption of the standard of care
    agent (eg, malabsorptive disorder, ulcerative disease,
    uncontrolled nausea, vomiting, diarrhea, or small bowel
    resection).
    aa) Hypersensitivity to standard of care agent or any of the
    excipients
    bb) Patients who were vaccinated with a live vaccine 2 weeks prior
    to the start of the CT
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the overall survival rate at 12 months (OS12) (landmark).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after start of treatment of patient.
    E.5.2Secondary end point(s)
    Secondary endpoints were:
     OS rate at 6 and 18 months in overall population and histological and prognostic subgroups.
     Overall survival (OS)
     Progression-free survival (PFS)
     Objective response rate (ORR)
     Safety/tolerability
     Quality of Life (QoL) as assessed by FKSI-DRS questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints were:
     OS rate at 6 and 18 months in overall population and histological and prognostic subgroups.
     Overall survival (OS)
     Progression-free survival (PFS)
     Objective response rate (ORR)
     Safety/tolerability
     Quality of Life (QoL) as assessed by FKSI-DRS questionnaire
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care agents
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    The study will end 18 months after the last patient is in.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 306
    F.4.2.2In the whole clinical trial 306
    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)
    The study drug (ipilimumab and nivolumab) is supplied by Bristol-Myers-Squibb (BMS). After the end of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study drug. Study drug will be provided through another mechanism at the discretion of BMS.
    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 Decision2018-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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