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    Summary
    EudraCT Number:2021-004310-19
    Sponsor's Protocol Code Number:W00090GE303/EORTC-2139-MG
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-09
    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 - BfArM
    A.2EudraCT number2021-004310-19
    A.3Full title of the trial
    Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB/C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Encorafenib used with binimetinib versus placebo in BRAF mutant stage IIB/C melanoma after surgery to evaluate the efficacy and safety in preventing melanoma recurrence
    A.4.1Sponsor's protocol code numberW00090GE303/EORTC-2139-MG
    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 SponsorPierre Fabre Médicament
    B.1.3.4CountryFrance
    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 supportPierre Fabre Médicament
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPierre Fabre Médicament
    B.5.2Functional name of contact pointIsabelle Klauck
    B.5.3 Address:
    B.5.3.1Street Address33 avenue Emile Zola
    B.5.3.2Town/ cityBoulogne - Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+337 87 29 60 13
    B.5.6E-mailisabelle.klauck@pierre-fabre.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 Yes
    D.2.1.1.1Trade name Braftovi
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Médicament
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEncorafenib
    D.3.2Product code W0090
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEncorafenib
    D.3.9.1CAS number 1269440-17-6
    D.3.9.2Current sponsor codeW0090
    D.3.9.4EV Substance CodeSUB177218
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) No
    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.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 Yes
    D.2.1.1.1Trade name Mektovi
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Médicament
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namebinimetinib
    D.3.2Product code W0074
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBinimetinib
    D.3.9.1CAS number 606143-89-9
    D.3.9.2Current sponsor codeW0074
    D.3.9.4EV Substance CodeSUB179942
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Resected BRAF V600E/K stage IIB/C melanoma
    E.1.1.1Medical condition in easily understood language
    Stage IIB/C melanoma with mutation in the V600E/K gene after surgery
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To prospectively assess whether treatment with encorafenib and binimetinib prolongs recurrence-free survival (RFS) as compared to placebo in resected pT3b-4bN0 BRAF V600E/K melanoma participants.
    E.2.2Secondary objectives of the trial
    1.To prospectively assess whether treatment with encorafenib and binimetinib prolongs distant metastasis-free survival (DMFS) as compared to placebo.
    2.To prospectively assess whether treatment with encorafenib and binimetinib prolongs overall survival (OS) as compared to placebo.
    3.To assess the safety and tolerability of encorafenib and binimetinib.
    4.To compare the patient-reported health-related quality of life (HRQoL) between the two arms during the treatment duration and after treatment completion.
    5.To provide additional PK data to support PK modelling and exposure response (efficacy and safety) relationship developments in this indication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Molecular Pre-screening
    1.Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations;
    2.Male or female ≥ 18 years of age;
    3.Surgically resected, with tumor free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanoma per AJCC 8th edition;
    4.Sentinel node (SN) staged node negative (pN0);
    5.Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma;
    6.Available tumor sample for central determination of the BRAFV600E/K mutation. FFPE tumor tissue block or a minimum of 10 slides, optimally up to 20 slides.
    Screening
    1.Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations;
    2.Presence of BRAF V600E/K mutation in tumor tissue as determined by local assay any time prior to screening (if done routinely in clinical practice) and/or the central laboratory. If the participant is screened based on local assay result, the BRAF V600E/K mutation status must be confirmed by the central laboratory prior to randomization;
    3.Participant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before the randomization (Day 1);
    4.Randomization within 12 weeks from full surgical resection including sentinel lymph node biopsy (SLNB);
    5.Recovered from definitive surgery (e.g. complete wound healing, no uncontrolled wound infections or indwelling drains);
    6.ECOG performance status of 0 or 1;
    7.Adequate haematological function:
    i.Absolute neutrophil count (ANC) ≥ 1.5 x 1000000000/L
    ii.Platelets ≥ 100 x 1000000000/L
    iii.Hemoglobin ≥ 9.0 g/dL
    8.Adequate renal function:
    Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft Gault formula;
    9.Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;
    10.Adequate hepatic function:
    i.Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL
    ii.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN
    11.Adequate cardiac function:
    i.Left ventricular ejection fraction (LVEF) ≥ 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram
    ii.Mean triplicate QT interval corrected for heart rate according to Fridericia’s formula (QTcF) value ≤ 480 msec and no history of QT syndrome
    12.Adequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;
    13.Negative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;
    14.Participants of childbearing / reproductive potential should use adequate birth control measures (see Appendix 4, section 10.4.2):
    Female participants are either postmenopausal for at least 1 year, surgically sterile for at least 6 weeks or must agree to take appropriate precautions to avoid pregnancy.
    Male participants must agree to take appropriate precautions to avoid fathering a child.
    E.4Principal exclusion criteria
    Molecular pre-screening
    1.Unknown ulceration status;
    2.Uveal and mucosal melanoma;
    3.Clinically apparent metastases (N+/M1);
    4.Microsatellites, satellites and/or in-transit metastases;
    5.Local (scar) recurrences.
    Screening
    1.Breast feeding women;
    2.Pregnancy;
    3.History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
    4.History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to randomization;
    i.Note 1: Thromboembolic or cerebrovascular events include stroke, transient ischemic attacks, cerebrovascular accidents, hemodynamically significant deep vein thrombosis, pulmonary emboli, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis;
    ii.Note 2: Participants with thromboembolic events related to indwelling catheters or other procedures may be enrolled;
    5.Previous or concurrent malignancy for the past 3 years. Except for non-melanoma skin cancer and any in situ cancer;
    6.Any condition with a life expectancy of less than 5 years;
    7.Participants with a prior cancer associated with RAS mutation;
    8.Previous treatment for melanoma beyond complete surgical resection (any prior systemic anticancer therapy; prior radiotherapy);
    9.Hypersensitivity to the study drugs or to any of the excipients;
    10.Participants with severe lactose intolerance;
    11.Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
    i.History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤ 6 months prior to randomization;
    ii.Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);
    iii.Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite optimal therapy;
    iv.Presence of clinically significant cardiac arrhythmias including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia (stable controlled atrial fibrillation or paroxysmal supraventricular tachycardia is accepted);
    12.Neuromuscular disorders that are associated with CK > ULN;
    13.Non-infectious pneumonitis and Interstitial Lung Disease;
    14.Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test at screening or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending;
    15.Participants with active bacterial, fungal, or viral infection, including, but not limited to: HBV, HCV, and known HIV or AIDS-related illness, or an infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.
    Note: Participants receiving prophylactic antibiotics are exceptions and may participate.
    Note: Participants with a positive HBsAg (i.e., either acute or chronic active hepatitis) are excluded. Those with positive anti-HBcAb but negative HBsAg and anti-HBsAb profile may be eligible upon review and approval by the sponsor or designee.
    Note: Participants with positive HCV antibody but undetectable HCV viral load may be eligible upon review and approval by the sponsor or designee.
    Note: Participants with confirmed stable HIV disease may be eligible if they have viral load < 50 copies/mL and CD4 count > 200 cells/mm3, and on stable antiretroviral therapy for at least 6 months, provided that they meet all other study eligibility criteria. Testing for HIV is not mandated for study entry; however, testing must be performed at sites where mandated locally following local clinical practice.;
    16.Unable to ingest or digest tablets and capsules. This can be caused by any impaired gastrointestinal function or disease, such as for example: ulcerative diseases, malabsorption syndrome, small bowel resection, ileus, etc. Or any condition causing uncontrolled nausea, vomiting or diarrhea;
    17.Presence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule according to Investigators’s judgement; those conditions should be assessed with the patient before randomization in the trial;
    18.Participant is a family member of the investigator or any associate, colleague and employee assisting in the study conduct (secretary, nurse, technician) or is otherwise in a position likely to represent a conflict of interest, the participant is only eligible if the informed consent has been sought by an appropriately qualified individual who is completely independent of this relationship;
    19.Participation in a clinical study with administration of an investigational product within 4 weeks or five times the half-life of the investigational product, whichever is longer, before the first dose of study treatment;
    20.Participants who has forfeited his / her freedom by administrative or legal award or is under guardianship.
    E.5 End points
    E.5.1Primary end point(s)
    •Recurrence-free survival (RFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 4.4 years from the accrual of the first patient.The longterm evaluation will take place 10 years from the randomization of the last
    patient.
    E.5.2Secondary end point(s)
    1.Distant metastasis-free survival (DMFS)
    2.Overall survival (OS)
    3.
    •Severity of adverse events and SAEs on-study graded according to NCI CTCAE Version 5.0
    •Changes from baseline and worst value on-study for clinical safety laboratory assessments, physical examinations, vital signs, ECGs, ECHO, dermatological examinations, ophthalmic examinations and ECOG performance status
    •Incidence of dose interruptions, dose modifications and discontinuation due to AEs and incidence of AEs requiring additional therapy
    4.
    •The change in the HRQoL from baseline to the average of the scores during the treatment
    •The change in the HRQoL from baseline to the average of the scores at months 18, 24, and 30
    5.Sparse PK sampling in all participants to quantify plasma concentrations of encorafenib, binimetinib, and their metabolites (LHY746 and AR00426032, respectively) using validated assays
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.At the time of DFMS analysis (Approximately 6.0 years from first patient in)
    2.At the time of the OS analysis (7 years from accrual end)
    3.At the time of the RFS analysis (Approximately 4.4 years from first patient in)
    4.At the time of the RFS analysis (Approximately 4.4 years from first patient in)
    5.At the time of the RFS analysis (Approximately 4.4 years from first patient in)
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Triple blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA108
    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
    Argentina
    Switzerland
    Ukraine
    Australia
    Brazil
    Canada
    Israel
    Russian Federation
    Serbia
    South Africa
    United Kingdom
    Austria
    Belgium
    Czechia
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    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
    End of study is defined as the point when all patients have had the opportunity to be followed for 10 years from study entry. If the last participant discontinues the follow-up for one of the following reasons: withdrawal of consent, loss to follow-up, or death, the end of study participation is defined as the time point when one of these events occurred for the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years13
    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: 652
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 163
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 541
    F.4.2.2In the whole clinical trial 815
    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)
    Patients will be treated as per standard of care depending on the disease stage at recurrence/relapse.
    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 Decision2021-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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