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    Summary
    EudraCT Number:2012-001141-41
    Sponsor's Protocol Code Number:08-C-0007
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-09-18
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2012-001141-41
    A.3Full title of the trial
    A PHASE I STUDY OF IPILIMUMAB (ANTI-CTLA-4) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH TREATMENT REFRACTORY CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF IPILIMUMAB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH TREATMENT REFRACTORY CANCER
    A.3.2Name or abbreviated title of the trial where available
    Ipilimumab in Pediatric Patients
    A.4.1Sponsor's protocol code number08-C-0007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01445379
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/264/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNational Cancer Institute NCI
    B.1.3.4CountryUnited States
    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 supportNational Cancer Institute NCI
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPEDIATRIC ONCOLOGY BRANCH (POB), NCI
    B.5.2Functional name of contact pointMelinda Merchant
    B.5.3 Address:
    B.5.3.1Street Address10 Center Dr - Bldg 10 CRC, Room 1W-3950
    B.5.3.2Town/ cityBethesda
    B.5.3.3Post codeMD 20892
    B.5.3.4CountryUnited States
    B.5.4Telephone number1301443-7955
    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 nameIpilimumab
    D.3.2Product code BMS-734016 / MDX010
    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 INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.3Other descriptive nameIPILIMUMAB
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant protein
    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
    Sarcoma - Wilm's Tumor - Lymphoma - Neuroblastoma
    E.1.1.1Medical condition in easily understood language
    Treatment-Resistant Solid tumor cancers
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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
    * To determine the tolerance and toxicity profile of ipilimumab at a range of doses up to, but not exceeding, the highest dose tolerated in adults in patients ≤ 21 years of age with refractory solid tumors.
    * To assess the pharmacokinetics of ipilimumab administered intravenously in patients ≤ 21 years of age with solid tumors refractory to standard therapy.
    E.2.2Secondary objectives of the trial
    * To quantify antitumor effects of ipilimumab in patients ≤ 21 years of age with solid tumors refractory to standard therapy.
    * To evaluate the immunomodulatory activity of ipilimumab in patients ≤ 21 years of age with solid tumors refractory to standard therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    AGE: Patients must be greater than or equal to 2 years and less than or equal to 21 years of age.

    DIAGNOSIS: Histologically confirmed solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilm's tumor, Hodgkin's or non-Hodgkin's lymphoma.

    MEASURABLE/EVALUABLE DISEASE: Patients must have measurable or evaluable tumors.

    PRIOR THERAPY:

    •The patient's cancer must have relapsed following or failed to respond to standard therapy and/or the patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival.
    •Patients must have completed their last dose of chemotherapy, monoclonal antibody, or investigational therapy at least 4 weeks prior to enrollment and patients that received irradiation must have completed therapy at least one week prior to enrollment. Biologic or other approved molecular targeted small molecule inhibitors with a short half-life
    must be stopped at least 1 week prior to enrollment. For patients who have undergone autologous stem cell transplantation, at least 3 months must have elapsed since transplant.
    •Patients must have recovered from the toxic effects (to a grade 1 or less) of all prior therapy prior to enrollment, with the exception of the following:

    ◦Hematological toxicity: recovery to levels required below
    ◦Low electrolyte levels (Such individuals should receive appropriate supplementation)
    ◦For patients on anticoagulant therapy or with pre-existing coagulation abnormalities, PT, PTT must return to baseline.
    ◦Liver function tests must resolve to values required below
    ◦Grade 3 hypoalbuminemia
    ◦Alopecia
    ◦Sterility
    PERFORMANCE STATUS: Patients greater than 10 years old must have a Karnofsky Score of greater than or equal to 50 and children less than 10 years old must have a Lansky score of greater than 50.
    HEMATOLOGIC FUNCTION: Patients must have adequate bone marrow function, defined as a peripheral absolute granulocyte count of greater than or equal to 1000/microL, hemoglobin greater than or equal to 8 gm/dl, and a transfusion independent platelet count greater than or equal to 50,000/microL.

    HEPATIC FUNCTION: Aspartate transaminase (AST) and alanine transaminase (ALT), less than or equal to 2.5-fold the upper limit of normal (ULN). Normal total bilirubin.

    RENAL FUNCTION: Patients must have normal age-adjusted serum creatinine (see table below) OR a creatinine clearance greater than or equal to 70 mL/min/1.73 m(2).

    INFECTIOUS DISEASE:

    A patient with viral hepatitis (HBV, HCV) or human immunodeficiency virus (HIV) will be excluded from trial to limit confounding variables in the assessment of the potential hepatic toxicity of ipilimumab and uncertain impact of ipilimumab administration on viral replication. Serology will not be required unless infection is clinically suspected. A positive hepatitis B titer does not exclude a patient if immunization has been performed and if there is no history of disease.

    INFORMED CONSENT: All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent (Pediatric Oncology Branch, NCI screening protocol for NIH patients) prior to performing studies to determine patient eligibility. After confirmation of eligibility, all patients or their legal guardians must voluntarily sign the IRB approved protocol specific informed consent to document their understanding of the investigational nature, the risks of this study and their willingness to receive the therapy and undergo the research studies involved including pharmacokinetic studies.

    DURABLE POWER OF ATTORNEY (DPA): Patients who are greater than or equal to 18 years of age will be offered the opportunity to assign a DPA so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired.

    BIRTH CONTROL: Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control which includes abstinence, while they are being treated on this study and for 60 days following the last dose. Females of childbearing potential must have a negative pregnancy test within 14 days prior to initiation of study therapy and prior to each additional dose of ipilimumab.
    E.4Principal exclusion criteria
    •Primary brain tumors
    •Clinically significant unrelated systemic illness, such as serious infections or organ dysfunction, which in the judgment of the Principal or Associate Investigators would compromise the patient's ability to tolerate the agents in this trial or are likely to interfere with the study procedures or results. This includes but is not limited to:

    ◦Critically-ill or medically unstable patients
    ◦Patients with active infection or other significant systemic illness
    ◦Patients with active diarrhea
    ◦Patients with active eye inflammation, uveitis
    ◦Presence of a symptomatic pleural effusion
    ◦Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance
    ◦History of malignant hyperthermia
    ◦Concurrent or history of autoimmune disease excluding stable asthma
    ◦Positive direct Coombs testing or history of hemolytic anemia
    ◦Patients with a history of ongoing or intermittent bowel obstruction
    •Concurrent radiation
    •Patients with a history of allogeneic bone marrow transplantation.
    •Untreated CNS metastases will render the patient ineligible however patients with a previous history of CNS metastases are eligible if: the metastases have been treated with surgery and/or radiotherapy, are clinically stable as evidenced by no requirements for corticosteroids, the patient has no evolving neurologic deficits and no progression in residual brain abnormalities without specific therapy are eligible one week post radiation or radiosurgery. Patients with asymptomatic subcentemeric CNS lesions will be eligible for trial if no immediate radiation or surgery.
    •Patients with a history of previous therapy with ipilimumab will be excluded from study participation.
    •Treatment with any of the following immunomodulatory agents within 14 days prior to study entry:
    Systemic corticosteroid therapy
    Erythropoeisis stimulating agents
    Retinoids
    Fenretinide
    Interferons or interleukins
    Cytokine-fusion proteins
    Growth hormone
    IVIG
    •Treatment with myeloid growth factors (GM-CSF or G-CSF) within 72 hours prior to study entry.
    •Patients with autoimmune disease, including autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders, sarcoid granuloma, myasthenia gravis, polymyositis, and Guillain-Barre syndrome.

    •Pregnant or breastfeeding females are excluded because ipilimumab may be harmful to the developing fetus or nursing child.
    •Concurrent administration of any other investigational agent.
    E.5 End points
    E.5.1Primary end point(s)
    * Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAEv3.0) until July 31, 2010. CTCAE version 4.0 (CTCAEv4.0) will be utilized beginning August 1, 2010.
    * Pharmacokinetic parameters will be reported: area under the curve, terminal half-life, maximum concentration, clearance, and volume of distribution.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At each dose level.
    E.5.2Secondary end point(s)
    Tumor response will be assessed using the RECIST criteria.
    Immunoregulatory Studies: Multiplex cytokine assays will be used to quantify circulating levels of selected cytokines in patients treated with ipilimumab and lymphocyte phenotyping will be used to assess changes in mononuclear subsets following ipilimumab therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of disease status will be performed at baseline prior to protocol enrollment, immediately prior to initiation of cycle 3 and prior to initiation of each cycle of maintenance therapy.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose Ranging
    E.7.2Therapeutic exploratory (Phase II) No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.1.1Number of subjects for this age range: 27
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 9
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 9
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children from age of 2 to 21 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 27
    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)
    Not available
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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