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    Summary
    EudraCT Number:2011-004200-38
    Sponsor's Protocol Code Number:N11RFA
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004200-38
    A.3Full title of the trial
    Phase II study exploring safety and efficacy of the combination of ipilimumab with radiofrequency ablation (RFA) in patients with unresectable uveal melanoma liver metastasis (SECIRA-UM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out whether treating patients who have liver metastases from eye melanoma with radiofrequency ablation combined with ipilimumab, will kill the tumor without them having too many adverse events.
    A.3.2Name or abbreviated title of the trial where available
    SECIRA-UM trial
    A.4.1Sponsor's protocol code numberN11RFA
    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 SponsorNKI-AVL
    B.1.3.4CountryNetherlands
    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 supportNKI-AVL
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBristol Myers-Squib
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRA
    B.5.2Functional name of contact pointSECIRA-UM contact
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310205122667
    B.5.5Fax number310205122679
    B.5.6E-maill.pronk@nki.nl
    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 AuthorisationNetherlands
    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 and solvent 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 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
    Unresectable uveal melanoma liver metastasis
    E.1.1.1Medical condition in easily understood language
    Patients that have eye melanoma with liver metastases that cannot be operated.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10030052
    E.1.2Term Ocular melanomas
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of the combination of RFA and Ipilimumab in patients with unresectable, pathologically confirmed hepatic metastases of uveal melanoma
    E.2.2Secondary objectives of the trial
    To determine immune-related progression free survival (PFS), overall survival (OS), clinical response benefit (irCR, irPR, and irSD as defined by irRC), and immune-related duration of response (for patients achieving an objective response);

    To evaluate changes in immunological and genetic parameters pre- and post- treatment with the combination of RFA and Ipilimumab;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults at least 18 years of age
    2. Performance Status 0 or I
    3. Histologically or cytologically confirmed unresectable metastatic uveal melanoma
    4. Subjects must have at least two liver metastases (one irRC measurable) – at least one feasible for RFA
    5. No prior systemic or local treatment
    6. No immunosuppressive medications
    8. Women of child bearing potential must agree to use a reliable form of contraceptive during the study treatment period and for at least 70 days following the last dose of study drug
    9. Men must agree to the use of male contraception during the study treatment period and for at least 180 days after the last dose of study drug.
    10. Absence of additional severe and/or uncontrolled concurrent disease
    11. No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical cancer in situ or adequately treated other cancer with eradicative intent for which the patient has been continuously disease-free for > 2 years.
    E.4Principal exclusion criteria
    1. Cerebral or meningeal metastasized uveal melanoma
    2. Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy;
    3. Prior immunotherapy
    4. Known history of infection with HIV
    5. Active infection requiring therapy, positive serology for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
    6. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events;
    7. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids;
    8. History of or current immunodeficiency disease, splenectomy or splenic irradiation; prior allogeneic stem cell transplantation;
    9. Use of other investigational drugs before study drug administration for systemic malignancy
    10. Pregnancy or nursing.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Response rate as measured by irRC of intra- and extrahepatic lesions, excluding the metastasis that is treated by RFA) at week 12 from the start of RFA and ipilimumab treatment. Response as well as progression will require confirmation through a subsequent scan at least 4 weeks apart.
    Toxicity and safety of treatment
    * DLT toxicities will be any unexpected SAE and AE deemed related to the investigational treatment. DLT observation period ranges from week 1 to week +10 after last Ipilimumab infusion into third patient of cohort.
    Cohort 1 consists of three patients. If 1 DLT is observed then a cohort 2 consisting of additional 3 patients is opened. If 2 DLT of the 6 patients is observed then the discontinuation of the study will be discussed with the ethics committee and BMS.
    In the case of no or only 1 DLT among the first 6 patients included the study will continue to accrue to a total of 34 patients.
    * DLT is also defined as the following treatment-related adverse events or laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0:
    1. Non-hematological toxicity ≥ grade 3
    2. irAE ≥ grade 3
    3. Dosing delay ≥ 3 weeks due to toxicity
    4. Hepatic bleeding grade 3 or 4
    5. Treatment related hepatic failure grade 3 or 4
    * Grade and type of adverse events in all patients
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be evaluated at 12 weeks after first admission of study drug.
    E.5.2Secondary end point(s)
    Efficacy
    * OS;
    * irPFS;
    * Clinical response benefit (irCR, irPR, and irSD as defined by irRC criteria);
    * Immune-related duration of response (for patients achieving an objective response).
    * Response according to MHC expression on the melanoma cells
    Analysis of immunological and genetic changes in the tumor and peripheral blood pre- and post- treatment
    Collection of PBMC pre, on day 1, 22, 43, 64, week 12, 16, 28, and every three months, and tumor biopsy mandatory day 1 and week 6, and optional in week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, 16, 24 and every 3 months after.
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state38
    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)
    Follow-up every 3 months until death.
    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 Decision2011-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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