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    Summary
    EudraCT Number:2011-001282-40
    Sponsor's Protocol Code Number:MORAb-004-201-Mel
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-07-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-001282-40
    A.3Full title of the trial
    A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects with Metastatic Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects with Metastatic Melanoma
    A.4.1Sponsor's protocol code numberMORAb-004-201-Mel
    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 SponsorMorphotek Inc
    B.1.3.4CountryUnited States
    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 supportMorphotek Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailLMedInfo@eisai.net
    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 nameMORAb-004
    D.3.2Product code MORAb-004
    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.3.9.2Current sponsor codeMORAb-004
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized IgG1/κ monoclonal antibody against endosialin (TEM-1)
    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
    Metastatic Melanoma
    E.1.1.1Medical condition in easily understood language
    Metastatic Melanoma is a type of skin cancer which has spread to other parts of the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    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
    [1] To evaluate the rate of Progression-Free-Survival (PFS) at 24 weeks of 2 dose levels of MORAb-004 in subjects with metastatic melanoma based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
    E.2.2Secondary objectives of the trial
    [1] To evaluate the Optimal Biological Dose (OBD) of MORAb-004 using a Pharmacokinetic (PK)/Pharmacodynamic (PD) model of drug activity
    [2] To correlate the pattern of TEM-1 expression in tumor samples with clinical parameters, including PFS
    [3] To assess the following additional clinical parameters: PFS over the course of the study, Overall survival (OS), Overall Response Rate (ORR) based on RECIST v1.1, Safety and tolerability of MORAb-004, and Tumor tissue-based and serum-based PD biomarkers.
    [4] Version 5.0 Note: Assessment of Primary and Secondary Objectives has been completed.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluation of Tissue-based PD markers. Tissue-based PD markers will be assessed by tumor biopsy taken at baseline and a second tissue sample taken between protocol days Cycle 1 Day 21 − Cycle 1 Day 28. Only the first 30 subjects will have both screening and on-treatment biopsies; for all other subjects, the second biopsy is optional.
    E.3Principal inclusion criteria
    [1] At least 18 years of age
    [2] Surgically sterile or who consent to use a medically acceptable method of contraception throughout the study period
    [3] Histologically confirmed diagnosis of metastatic cutaneous (nonocular, nonmucosal) melanoma
    [4] At least one prior systemic treatment for metastatic melanoma with disease progression following treatment
    [5] Measurable disease, as defined by RECIST v.1.1, assessed within 4 weeks prior to study entry
    [6] Prior anticancer therapy (chemotherapy, immunotherapy, or radiation therapy) must have been completed at least 3 weeks (21 days) prior to starting MORAb-004 therapy, and all treatment-associated toxicity must be resolved to Grade 1 or less before the first infusion of study drug (MORAb-004)
    [7] Life expectancy of at least 3 months as estimated by the investigator
    [8] Any other significant medical conditions well-controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1
    [9] ECOG Performance Status of 0 or 1 at screening
    [10] Disease sites amenable to protocol-specified tissue biopsy (Note: All subjects will have protocol-specified biopsy at screening. The second, on-treatment biopsy will be required in the first 30 randomized subjects and is optional for all subsequently randomized subjects.)
    [11] Willingness and ability to provide written informed consent
    [12] Laboratory test results within the 2 weeks prior to Study Day 1: Absolute neutrophil count at least 1.5×10^9/L; Platelet count at least 100 × 10^9/L; Hemoglobin at least 8 g/dL; Creatinine no greater than 1.5 × ULN (NCI CTCAE Grade 1); Bilirubin less than 1.5 × ULN (NCI CTCAE Grade 1); Aspartate aminotransferase and alkaline phosphatase less than 2.5 × ULN (NCI CTCAE Grade 1); Activated partial thromboplastin time (aPTT) and prothrombin time (PT) less than 1.5 × ULN (NCI CTCAE Grade 1)
    E.4Principal exclusion criteria
    [1] No prior systemic treatment for metastatic melanoma
    [2] Evidence of active malignancy other than metastatic melanoma requiring treatment within the last 5 years (other than basal cell or squamous cell skin cancer)
    [3] Clinically significant heart disease
    [4] ECG demonstrating clinically significant arrhythmia
    [5] Any other serious systemic disease, including active bacterial or fungal infection, or any medical condition requiring cytotoxic therapy or chronic use of systemic corticosteroids (use for at least 4 consecutive weeks)
    [6] Active viral hepatitis or symptomatic HIV infection (Asymptomatic positive serology is not exclusionary.)
    [7] Breast-feeding, pregnant, or likely to become pregnant during the study
    [8] Known allergic reaction to a prior monoclonal antibody therapy
    [9] Previous treatment with MORAb-004 (anti-TEM-1)
    [10] Any evidence of brain metastasis. (Note: Screening brain MRI will be performed to rule out the presence of brain metastases.)
    E.5 End points
    E.5.1Primary end point(s)
    [1] PFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 week PFS
    Imaging by MRI/CT: screening, D22 (even # cycles), final visit
    E.5.2Secondary end point(s)
    [1] Radiologic PFS, including rate at 16 and 52 weeks
    [2] OS
    [3] ORR
    [4] Serum MORAb-004 concentrations
    [5] Serum marker of TEM-1 inhibition or other proteins in the TEM-1 pathway (potentially including platelet-derived growth factor, soluble galectin-3 or galectin-3-BP)
    [6] Tissue based markers of TEM-1 pathway, including TEM-1, galectin-3, fibronectin, mean pericyte index, leukocyte phenotyping, total vessel density, and total pericyte count and BRAF/NRAS mutation status
    [7] Adverse events (AEs), including drug hypersensitivity reactions (DHAEs)
    [8] Clinical laboratory tests (serum chemistry, hematology, urinalysis)
    [9] Tolerability (discontinuations, treatment delays)
    [10] Physical examinations, including vital signs assessment and neurological examinations
    [11] Standard ECG assessments, including a clinical evaluation of prolongation of QTc interval
    [12] Human antihuman antibody (HAHA) assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 and 52 week PFS
    Imaging by MRI/CT: screening, D22 (even # cycles), final visit
    Disease assessment: screening, D22 (each cycle), final visit
    Serum-based PD biomarkers: screening, D1, D3-4, D15, D22 (cycle 1), D1, D15 (all subsequent cycles), final visit
    Biopsy: D1 (all subjects), D21-28 (first 30 subjects)
    Serum concentration of MORAb-004: D1, D3-4, D8, D15, D22 (cycle 1), D1, D15 (all subsequent cycles), final visit
    HAHA assessment: D1 and D15 (each cycle), final visit
    Clinical Labs: screening, D1 and D15 (each cycle), final visit
    Physical exam: screening, D1 (each cycle), the final visit
    Vital signs: screening, D1, D8, D15, D22 (each cycle), final visit
    AEs: each visit
    ECG: pre and post infusion D1, D22 (cycles 1 & 2) and during infusion D1 (cycle 3)
    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 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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    IMP at different dose
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Germany
    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 visit of the last subject in follow-up [Going forward the end of study for individual subjects will be defined as the completion of the 45 day follow-up visit]
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 80
    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)
    Subjects will revert back to the local standard of care following participation in the trial
    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 Decision2011-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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