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    Summary
    EudraCT Number:2013-002408-15
    Sponsor's Protocol Code Number:Ipi4
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-10-08
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-002408-15
    A.3Full title of the trial
    Phase IV ipilimumab in melanoma

    A National, Multicenter, Interventional Study in Patients with Unresectable or Metastatic Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A national phase IV study with Ipilimumab for patients with advanced malignant melanoma
    A.4.1Sponsor's protocol code numberIpi4
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportSouth-Eastern Norway Regional Health Authority
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointCoordinating MD/Medical monitor
    B.5.3 Address:
    B.5.3.1Street AddressPostbox 4953 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeNO-0424
    B.5.3.4CountryNorway
    B.5.4Telephone number+4791502770
    B.5.6E-mailuxtour@ous-hf.no
    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 Yervoy
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 injection/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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    Patients diagnosed with unresectable or metastatic melanoma, cutaneous, ocular, mucosal and unknown primary tumor
    E.1.1.1Medical condition in easily understood language
    The study will include patients with advanced malignant melanoma who have reseived one or more prior treatment(s) for their disease.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To estimate the incidence and severity of adverse reactions in adult patients treated with ipilimumab in the post-approval setting.
    •To describe the management of adverse reactions (eg, diarrhea, colitis, hepatitis, elevated liver enzymes, hypopituitarism, hypothyroidism, rash, neurologic syndromes) and their outcomes in ipilimumab-treated patients in the post-approval setting
    E.2.2Secondary objectives of the trial
    •To describe patterns of care for adult patients receiving any therapy for unresectable or metastatic melanoma (dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination, etc.)
    • To describe Health-Related Quality of Life (HRQL) and impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
    •To describe real-world use in the treatment of unresectable or metastatic melanoma including ipilimumab (i.e identify type and incidence of toxicities and the manner they are managed in routine clinical practice.
    •To assess Overall Survival (OS) and Progression Free Survival (PFS) in patients receiving ipilimumab for unresectable or metastatic melanoma

    Exploratory objective:Identify predictive biomarkers of long term study survivors who might have substantially benefited from ipilimumab
    therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically or cytologically confirmed diagnosis of malignant melanoma
    •Previously-treated unresectable Stage III or Stage IV melanoma (AJCC 2010)
    •Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma are permitted.
    •ECOG performance status of 0 or 1.
    •Men and women ≥ 18 years of age
    •Adequate hematologic, renal and hepatic function, specifically:
    − WBC ≥ 2500/uL
    − Absolute neutrophil count (ANC) ≥ 1000/uL
    − Platelets ≥ 75 x 103/uL
    − Hemoglobin ≥ 9 g/dL
    − Creatinine ≤ 2.5 x ULN
    − AST/ALT ≤ 3 x ULN for subjects without liver metastasis; ≤ 5 x ULN for subjects with liver metastasis
    − Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
    •Women of childbearing potential (WOCBP) and men must be using an acceptable method as described in section 7.2 to prevent pregnancy.
    •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
    E.4Principal exclusion criteria
    • History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Patients with vitiligo is NOT excluded.
    • MRI detected active brain metastatis wich require other therapies such as surgery and/or radio therapy. Patients already treated for their brain metastasis, surgery or radio therapy, and have had stable desease for more than two month and NOT requiring steroids may however be includet in this trial.
    • Uncontrolled infectious diseases – requires negative tests for clinically suspected HIV, HBV and HCV. If positive results are not indicative of true active or chronic infection, the subject may enter the study after discussion and agreement between the Investigator and the Medical Monitor.
    • History of or current immunodeficiency disease, splenectomy or splenic irradiation
    • Prior allogeneic stem cell transplantation
    •Pregnancy
    • Women who are breastfeeding
    • Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea
    • History of allergic reaction to parenteral administered recombinant protein product
    • Any reason why, in the opinion of the investigator, the patient should not participate.

    E.5 End points
    E.5.1Primary end point(s)
    The study is an observational study and not intended to test any hypothesis, but can
    be hypothesis generating.

    The goal of this study is to understand how ipilimumab is being used, its safety profile, and the manner in which ARs are managed in routine clinical practice. Another goal is to identify predictive biomarkers. Further, this study will provide information on the influence that the availability of ipilimumab as a treatment option exerts on the following health outcomes for patients with unresectable or metastatic melanoma:
    • Real-world patterns of care
    • Quality of life
    • Treatment effectiveness (Overall Survival, Progression free survival).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before every treatment infusion, at week 12, 16 and 24 and then every 12 weeks for up tp 3 years.
    E.5.2Secondary end point(s)
    Not defined
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To identify predictive biomarkers of long term study survivors who might have substantially benefited from ipilimumab therapy.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned8
    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
    Estimated date of last patient completed: October 2018
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state100
    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 normal treatment if any or other clinical trials
    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 Decision2013-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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