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    Summary
    EudraCT Number:2015-002971-12
    Sponsor's Protocol Code Number:IMCgp100-201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-11
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-002971-12
    A.3Full title of the trial
    A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy
    of IMCgp100 in Combination with Durvalumab (MEDI4736) or
    Tremelimumab or the Combination of Durvalumab and Tremelimumab
    Compared to IMCgp100 Alone in Patients with Advanced Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test if IMCgp100 in combination with Durvalumab or Tremelimumab or the combination of Durvalumab and Tremelimumab compared to IMCgp100 alone is safe and effective in patients with advanced skin cancer.
    A.4.1Sponsor's protocol code numberIMCgp100-201
    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 Limited
    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 Limited
    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 pointMark Moyer
    B.5.3 Address:
    B.5.3.1Street AddressSix Tower Bridge, 181 Washington Street, Suite 200
    B.5.3.2Town/ cityConshohocken,
    B.5.3.3Post codePA 19428
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12673324508
    B.5.6E-mailmark.moyer@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.3.2Product code IMCgp100
    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 INNIMCgp100
    D.3.9.2Current sponsor codeIMCgp100
    D.3.9.3Other descriptive nameIMCGP100
    D.3.9.4EV Substance CodeSUB66733
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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.IMP: 2
    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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNDURVALUMAB
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.IMP: 3
    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 nameTremelimumab
    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 INNTremelimumab
    D.3.9.1CAS number 745013-59-6
    D.3.9.3Other descriptive nameTremelimumab
    D.3.9.4EV Substance CodeSUB37101
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.IMP: 4
    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.3.2Product code IMCgp100
    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 INNIMCgp100
    D.3.9.2Current sponsor codeIMCgp100
    D.3.9.3Other descriptive nameIMCGP100
    D.3.9.4EV Substance CodeSUB66733
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 Cutaneous Melanoma
    E.1.1.1Medical condition in easily understood language
    Advanced skin cancer
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025655
    E.1.2Term Malignant melanoma of skin
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib: To characterize the safety and tolerability, and subsequently identify the MTD or RP2D, of the combination of durvalumab or tremelimumab with IMCgp100 (Arms 1 and 2) and tremelimumab + durvalumab with IMCgp100 (Arm 3). To describe the safety of single-agent IMCgp100 at doses higher than 68 mcg on a weekly basis (Arm 4a); identify the MTD or RP2D of single-agent IMCgp100 administered at doses higher than 68 mcg on a weekly basis (Arm 4a) using a slower intra-patient dose escalation. To describe the safety of administering single-agent IMCgp100 at a dose of 68 mcg three times per week (Arm 4b).

    Phase II: To evaluate the ORR of IMCgp100 using RECIST v.1.1 criteria as a single agent (Arm 4) and in combination with checkpoint inhibition with durvalumab (Arm 1), tremelimumab (Arm 2), or the combination of durvalumab and tremelimumab (Arm 3).
    E.2.2Secondary objectives of the trial
    To characterize the safety and tolerability of single agent IMCgp100 (given alone in Arm 4) and in combination with durvalumab and/or tremelimumab.

    To characterize the PK profile of single agent IMCgp100 (given alone in Arm 4) and in combination with durvalumab and/or tremelimumab in Arms 1, 2, and 3.

    To assess potential predictors of efficacy of gp100 and/or PDL1 expression or baseline lactate dehydrogenase (LDH) level with IMCgp100 in combination with durvalumab and/or tremelimumab in Arms 1, 2, and 3 and IMCgp100 alone in Arm 4.

    To assess the preliminary anti tumor efficacy of IMCgp100 alone and in combination with durvalumab and/or tremelimumab.

    To evaluate the incidence of anti IMCgp100, anti durvalumab and anti tremelimumab antibody formation following multiple infusions of IMCgp100 alone and in combination with durvalumab and/or tremelimumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Written informed consent must be obtained from all patients prior to any study procedures.
    3. Patients with advanced non-uveal melanoma defined as unresectable Stage III or metastatic Stage IV disease. Patients with acral or mucosal melanoma are acceptable. Patients with melanoma of unknown primary source are acceptable for Phase Ib cohorts (Arms 1 to 4), but are excluded in Phase II cohorts. Patients with the diagnosis of uveal melanoma are excluded from all cohorts
    4. Phase Ib Arm 4 and Phase II: Patients with disease progression following initiation of treatment with an approved PD-1 inhibitor. No prior cytotoxic therapy in the advanced setting is permitted. Patients with BRAF mutations must be refractory to approved BRAF-based therapy. CTLA-4-inhibition therapy is acceptable as a prior line of therapy or in combination with anti-PD-1 therapy
    5. Note: intentionally left blank by Sponsor in order to align with Protocol revision.
    6. Phase Ib Arms 1, 2 and 3: no restriction on prior therapy
    7. Human leukocyte antigen-A*0201 (HLA- A*0201) positive
    8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    9. Life expectancy of at least 3 months
    10. Phase II cohorts only: patients must have measurable disease according to RECIST v.1.1 criteria. Patients enrolled in Phase Ib cohorts must have evaluable disease
    11. Phase Ib Arm 4 and Phase II cohorts only: Patients must have a site of disease amenable to biopsy that is not an index lesion, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Phase Ib Arms 1-3 patients need not have disease accessible to biopsy
    12. Those receiving prior immunotherapy must meet all of the following conditions:
    -Must not have experienced an immune-related adverse event (irAE) which was the reason for permanent discontinuation of prior immunotherapy in the most recent prior treatment regimen

    - All irAEs while receiving prior immunotherapy must have resolved to ≤ grade 1 or Baseline prior to Screening for this study. Must not have experienced a ≥ grade 3 immune-related AE within the past 16 weeks or any grade 4 life-threatening AE (regardless of duration) or neurologic or ocular AE of any grade while receiving prior immunotherapy. (NOTE: Patients with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy, but must have no history of adrenal crisis and be asymptomatic)

    - Patients currently receiving chronic corticosteroid treatment (longer than 8 weeks duration) for management of pre-existing adverse events, or patients with a history of chronic corticosteroid treatment longer than 8 weeks’ duration for adverse events within 6 months of Screening are excluded
    E.4Principal exclusion criteria
    1. Presence of untreated or symptomatic central nervous system metastases, or central nervous system metastases that currently require local therapy (such as radiotherapy or surgery), or require doses of corticosteroids within the prior 4 weeks.
    2. History of severe hypersensitivity reactions to other monoclonal antibodies (mAb)s.
    3. History of treatment-related interstitial lung disease/pneumonitis.
    4. Patient with any out of range laboratory values.
    • Serum creatinine > 1.5 x ULN and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min
    • Total bilirubin > 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
    • Alanine aminotransferase (ALT) > 3 x ULN
    • Aspartate aminotransferase (AST) > 3 x ULN
    • Absolute neutrophil count (ANC) < 1.0 x 109/L
    • Absolute lymphocyte count < 0.5 x 109/L
    • Platelet count < 75 x 109/L
    • Hemoglobin (Hgb) < 8 g/dL
    • Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events, (CTCAE) > grade 1
    5. Clinically significant cardiac disease or impaired cardiac function.
    • Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association NYHA grade ≥ 2), uncontrolled hypertension or clinically significant arrhythmia currently requiring medical treatment
    • QTcF >470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome
    • Acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening
    6. Active autoimmune disease or a documented history of autoimmune disease within 3 years before Screening (or as indicated below), including the following:
    • A documented history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease, within 3 years)
    • Patients with vitiligo, alopecia, managed hypothyroidism (on stable replacement doses), psoriasis, resolved childhood asthma/atopy, well-controlled asthma and type I diabetes mellitus are NOT excluded
    7. Recent (< 12 months) active diverticulitis (PhIb combination arms and PhII only)
    8. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy before Screening is initiated.
    9. Known history of human immunodeficiency virus (HIV) infection.
    10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, currently requiring medical intervention, per institutional protocol.
    11. Malignant disease, other than that being treated in this study.
    12. Any medical condition that would, in the investigator’s judgment, prevent the patient’s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
    13. Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and any prior immunotherapy approach, 4 weeks is indicated as washout period.
    14. Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.
    15. Chronic, systemic corticosteroid use
    16. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
    17. Major surgery as defined by the investigator within 2 weeks of the first dose of study treatment (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
    18. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass.
    19. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GMCSF, M-CSF) ≤ 2 weeks prior start or study drug. Patients must have completed therapy with hematopoietic colony-stimulating factors at least 2 weeks before the first dose of study drug is given. An erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent.
    20. Pregnant or lactating women
    21. Women of child-bearing potential who are sexually active with a non-sterilized male partner must agree to use 2 methods of highly effective contraception. Highly effective methods of contraception are described in Section 6.7 Contraception.
    22. Male patients must be surgically sterile or use double barrier contraception method from enrollment through treatment and for 6 months following administration of the last dose of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib: Number of Dose limiting toxicity(ies) (DLTs)

    Phase II: Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLTs observed in the first 2 cycles of combination treatment (C1D15 through C2D28) for patients enrolled in the 3 Phase Ib cohorts.

    The primary endpoint of the study will be assessed as ORR per RECIST v.1.1; however, patients experiencing Progressive disease (PD) per RECIST v.1.1 criteria may continue to be treated until meeting the criteria for unequivocal, confirmed PD by Immune related response criteria modified (irRC).
    E.5.2Secondary end point(s)
    Safety incidence and severity of AEs and SAEs including changes in laboratory parameters, vital signs and electrocardiogram (ECG)

    Tolerability: Dose interruptions, reductions and dose intensity of all administered study medications

    Serum PK parameters (eg, AUC, Cmax, time of maximum concentration [Tmax], and t1/2) of all administered study medications)

    Correlation of PD-L1 and gp100 evaluated in biopsies taken in the Screening period with anti-tumor activity

    Progression free survival (PFS), duration of response, time to response, and disease control rate (DCR)

    Formation of Anti-drug antibody (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    AEs and SAEs: From baseline at each study visit.
    PK: samples taken at various timepoints during both phase Ib and II.
    PFS: time from first dose of IMCgp100 until date of disease progression or death.
    Duration of response: time from first documented response until date of documented progression or death in the absence of disease progression.
    Time to response: time from initiation of therapy to time that Overall Survival (OR) per RECISTv1.1 is achieved.
    DCR: proportion of patients with either a best response of PR or CR or with SD over 24 weeks after first dose in the study.
    ADA samples: pre-dose at C1D1, C2D15, C3D15 and all odd numbered cycles through C13 (“CX”) and at 30‐day End of Treatment visit. ADA samples to coincide with PK samples in Ph II during odd numbered cycles (CX’).
    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 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
    Phase Ib and II
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The phase II part of the study will be randomized.
    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 trial7
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    France
    Germany
    Italy
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the study will be when a minimum of 80% of the patients in all treatment arms in the Phase II part have completed the follow up for disease progression or discontinued the study for any reason, and all patients have completed treatment and the 90-day safety follow up period, or if the study is terminated early.
    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 months3
    E.8.9.2In all countries concerned by the trial days20
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 224
    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)
    Once the subject ends participation in the trial they may no longer receive the study drugs and will discuss with their doctor other treatment options for cutaneous melanoma.
    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 Decision2016-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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