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    Summary
    EudraCT Number:2010-019290-15
    Sponsor's Protocol Code Number:IMCgp100/01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-17
    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 number2010-019290-15
    A.3Full title of the trial
    A Phase I/II, Open label, Dose Finding Study to Assess the Safety, Tolerability and Efficacy of IMCgp100, a Monoclonal T Cell Receptor anti-CD3 scFv Fusion Protein in Patients With Advanced Malignant Melanoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/II Study of IMCgp100 in Patients with Advanced Malignant Melanoma
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberIMCgp100/01
    A.5.4Other Identifiers
    Name:Not ApplicableNumber:Not Applicable
    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 SponsorImmunocore Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportImmunocore Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunocore Ltd.
    B.5.2Functional name of contact pointHead of Development
    B.5.3 Address:
    B.5.3.1Street Address101 Park Drive, Milton Park
    B.5.3.2Town/ cityAbingdon
    B.5.3.3Post codeOX14 4RY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441235438600
    B.5.5Fax number+441235438601
    B.5.6E-mailNamir.Hassan@immunocore.com
    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 nameIMCgp100
    D.3.2Product code IMCgp100
    D.3.4Pharmaceutical form 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 codeIMCgp100
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 typeFusion 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
    Advanced Malignant Melanoma in patients with Stage IV or unresectable Stage III disease for whom no standard effective therapy exists.
    E.1.1.1Medical condition in easily understood language
    Malignant Melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ARM 1
    • To define the dose of IMCgp100 recommended for further investigation based on dose limiting toxicity (DLT) and pharmacokinetic (PK) data in patients with stage IV or unresectable stage III malignant melanomas. (Completed)
    • To evaluate the safety and tolerability of IMCgp100 following multiple weekly IV administrations at doses of 20mcg-50mcg.

    ARM 2
    • To establish the Maximum Tolerated Dose (MTD) of IMCgp100 based on Dose Limiting Toxicity (DLT) or recommended phase II dose (RP2D) when given daily over four days to patients with stage IV or unresectable Stage III malignant melanomas.
    • To evaluate the safety and tolerability of IMCgp100 following multiple daily IV administrations at the established RP2D.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of a single dose of IMCgp100 (Completed)
    • To characterize the PK exposure of IMCgp100 when administered intravenously weekly or daily to patients with stage IV and unresectable stage III malignant melanomas.
    • To characterize changes in tumour burden following multiple infusions of IMCgp100 by RECIST 1.1 criteria in evaluable patients.
    • To evaluate the incidence of anti-IMCgp100 antibody formation following multiple infusions of IMCgp100.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pathologically documented Stage IV malignant melanoma or
    unresectable Stage III melanoma for which no standard effective therapy exists or for which an appropriate window exists between alternative therapeutic options. Patients for whom early treatment with vemurafenib is indicated e.g. rapidly progressing or symptomatic disease, are excluded from this trial.
    2. Previous surgery (other than resection of skin metastases), radiotherapy, chemotherapy, immunotherapy or experimental therapy completed >4 weeks before and all adverse events resolved to ≤ grade 1. In cases where localised radiotherapy has been applied, treatment with IMCgp100 can be commenced after a two week period.
    3. HLA A2 positive.
    4. ≥ 18 years old.
    5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
    6. For patients in the Dose Expansion part only, measurable disease according to RECIST 1.1 criteria. Patients participating in the dose escalation arms only require aeessable disease.
    7. Life expectancy >3 months.
    8. Blood tests within the following parameters:
    a. Platelet count ≥100 x 10e9/L
    b. Haemoglobin ≥9g/dL (blood transfusion to achieve this level is permitted)
    c. Calculated creatinine clearance ≥50 mL/min using the modified Cockroft- Gault equation
    d. Neutrophil count ≥1x10e9/L
    e. Lymphocyte count ≥0.5x10e9/L
    9. Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 6 months following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile.
    10. Male patients must be surgically sterile or willing to use a double barrier contraception method upon enrolment, during the course of the study, and for 6 months following the last study drug infusion.
    11. Patients with a history of adrenal insufficiency, maintained on stable replacement dose corticosteroid (<10 mg/d prednisone or the equivalent) are eligible for treatment with IMCgp100, unless there is a past history of adrenal crisis. Eligible patients with a history of adrenal insufficiency receiving replacement dose corticosteroid must receive prophylactic stress dose corticosteroid prior to dosing during the first four doses of IMCgp100 treatment, regardless of weekly or daily dosing regimen.
    12. Able to give informed consent.
    E.4Principal exclusion criteria
    1. Symptomatic brain metastases that are unstable, require steroids, or that have required radiation within the last 28 days.
    2. Other active malignancy in the past 5 years except carcinoma in situ, completely excised non-melanomatous skin cancer or any other malignancy that in the opinion of the investigator is considered to be cured.
    3. Comorbid medical condition that would increase the risk of toxicity in the opinion of the investigator or sponsor. Any symptomatic ongoing infection must be resolved before the patient can be treated in the study.
    4. Uveitis
    5. Had myocardial infarction within 1 year before enrolment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina or unstable cardiac arrhythmia requiring medication.
    6. Has an ejection fraction <50%.
    7. Clinically significant electrocardiogram (ECG) changes that obscure the ability to assess the RR, PR and QT intervals. Patients with QTc calculated by Bazetts or locally preferred formula which is greater than 500ms.
    8. Has hepatic function as follows:
    - Aspartate aminotransferase >2.5 x upper limit of normal (ULN)
    - Alanine aminotransferase >2.5 x ULN
    - Bilirubin >2.0 x ULN
    - Prothrombin time or partial thromboplastin time>1.5 x ULN
    9. Bleeding diathesis.
    10. Immunosuppressive condition or treatment including previous transplantation, splenectomy or known HIV infection.
    11. Has a history of adult seizures.
    12. Patients with evidence of a raised intracranial pressure in Arm2 of the study who will have a CSF sample taken
    13. Patients receiving chronic corticosteroid treatment (longer than 8 weeks duration) for management of pre-existing adverse events at any dose, or patients with a history of chronic corticosteroid treatment longer than 8 weeks duration for adverse events within 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    • The MTD or RP2D for IMCgp100 when given weekly or daily
    • Number (percentage) of patients reporting treatment emergent adverse events
    • Number of patients experiencing clinically significant or ≥ Grade 3 according to CTCAE v4.0 changes in safety laboratory tests, physical examinations, ECGs or vital signs
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Safety Monitoring Committee Meetings between dose escalations, at end of dose escalation, after 10 patients have been dosed in the expansion part of Arm 1 and after 5 patients have been dosed in the expansion part of Arm 2.
    E.5.2Secondary end point(s)
    • A pre-determined PK model will be used to measure the Cmax concentration in each successive cohort to predict whether the Cmax in the next cohort will exceed 1nM (completed).
    • PK parameters: Cmin (minimum observed concentration), Cmax (maximum observed concentration) and AUC (area under the curve) for weekly or daily dosing.
    • Incidence of Anti-IMCgp100 antibody formation.
    • Overall Best Response, Overall Response Rate, Complete Response and Partial Response Rate, duration of response, as per RECIST 1.1 in evaluable patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    ARM 1 DOSE ESCALATION:
    • PK:
    Cycle 1: Days 1, 2, 3, 8 & 30 and 6 wks post last dose.
    1st rpt Cycle: Days 1, 2, 8, 9, 15, 22, 29, 36 and 66
    2nd or 3rd rpt cycle: Days 1, 2, 66 & 6 weeks post last dose
    • Anti-IMCgp100 antibodies: 6 weeks after last dose
    • Overall best response:
    Cycle 1: Screening and Days 8 and 30
    Add Cycles: Screening and Days 22 and 66
    ARM 1 DOSE EXPANSION:
    • PK:
    Cycle 1: Days 1, 2, 8, 15, 22, 29, 36, 43 & 50
    Add cycles: Day 50
    • Anti-IMCgp100 antibodies: Days 1 & 50 all cycles
    • Overall best response: Screening and Day 53-56

    ARM 2 DOSE ESCALATION AND EXPANSION
    • PK:
    Cycle 1: Days 1, 2, 3, 4 and 5
    • Anti-IMCgp100 antibodies: Day 1 of each cycle and at EOS (Day 55)
    • Overall best response: Screening and Day 36-42 in every second cycle
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    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 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
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 86
    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)
    See protocol
    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 Decision2010-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-16
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