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    Summary
    EudraCT Number:2017-003038-98
    Sponsor's Protocol Code Number:BeyPro2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003038-98
    A.3Full title of the trial
    An evaluation of the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
    Valutazione dell’efficacia oltre la progressione di malattia di vemurafenib in combinazione con cobimetinib associati al trattamento locale rispetto ad un trattamento di seconda linea in pazienti con melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale con vemurafenib e cobimetinib in combinazione in prima linea.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
    Studio per valutare l’efficacia oltre la progressione di malattia di vemurafenib in combinazione con cobimetinib associati al trattamento locale rispetto ad un trattamento di seconda linea in pazienti con melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale con vemurafenib e cobimetinib in combinazione in prima linea.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberBeyPro2
    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 SponsorINTERGRUPPO MELANOMA ITALIANO
    B.1.3.4CountryItaly
    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 supportRoche S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS s.r.l.
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressPalazzo Aliprandi, Via Matteotti 10
    B.5.3.2Town/ cityDesio (MB)
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number003903626331
    B.5.5Fax number00390362633633
    B.5.6E-mailosservatorio@opis.it
    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 ZELBORAF - 240 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) 56 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION GmbH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 name-
    D.3.2Product code [-]
    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 INNVEMURAFENIB
    D.3.9.1CAS number 918504-65-1
    D.3.9.2Current sponsor codeRO5185426
    D.3.9.4EV Substance CodeSUB32161
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 COTELLIC
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION GmbH
    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 name-
    D.3.2Product code [-]
    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 INNCOBIMETINIB
    D.3.9.1CAS number 934660-93-2
    D.3.9.2Current sponsor codeRO5514041
    D.3.9.4EV Substance CodeSUB122319
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 OPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 name-
    D.3.2Product code [-]
    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 INNnivolumab
    D.3.9.2Current sponsor codenivolumab
    D.3.9.3Other descriptive namenivolumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 RoleComparator
    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 KEYTRUDA - 50 MG- POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 name-
    D.3.2Product code [-]
    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 INNpembrolizumab
    D.3.9.2Current sponsor codepembrolizumab
    D.3.9.3Other descriptive namepembrolizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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
    BRAFV600 mutation-positive metastatic melanoma in focal progression
    Melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale
    E.1.1.1Medical condition in easily understood language
    Metastatic melanoma
    Melanoma metastatico
    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
    The primary objective of the study is to evaluate the efficacy, in terms of overall survival, of vemurafenib combined with cobimetinib associated with local treatment compared with second-line therapy in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
    L’obiettivo primario dello studio è di valutare l’efficacia, in termini di sopravvivenza globale, di vemurafenib in combinazione con cobimetinib associati al trattamento locale rispetto alla terapia di seconda linea in pazienti con melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale con vemurafenib e cobimetinib in combinazione in prima linea.
    E.2.2Secondary objectives of the trial
    - To compare progression-free survival of patients receiving treatment beyond focal progression vs second-line treatment;
    - To compare the adverse event profiles in patients receiving treatment beyond progression vs. second-line treatment;
    - To evaluate the prognostic role of focal versus non-focal progressive disease.
    - Confrontare la sopravvivenza libera da progressione (Progression Free Survival - PFS) per i pazienti che hanno ricevuto il trattamento oltre la progressione focale rispetto al trattamento di seconda linea;
    - Confrontare i profili degli eventi avversi nei pazienti che hanno ricevuto il trattamento oltre la progressione rispetto al trattamento di seconda linea;
    - Valutare il ruolo prognostico di malattia progressiva focale rispetto a non focale.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Ancillary biomarker study, version 2.0 date 15th november 2017
    Objective: to provide more information on how bloodstream proteins and/or genes affect the possible response or lack of response to treatment, so that new therapeutic options can be identified or developed for patients.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio sui biomarkers, versione 2.0 del 15.11.2017.
    Obiettivo: fornire ulteriori informazioni sul modo in cui le proteine e o i geni presenti nel sangue influiscono sulla possibile riposta o mancata risposta al trattamento in studio, in modo da poter individuare o sviluppare nuove opzioni terapeutiche per i pazienti.
    E.3Principal inclusion criteria
    - Patients with histologically confirmed melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition;
    - Patients previously untreated for metastatic melanoma;
    - Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) by a validated mutational test;
    - Adequate performance status to receive vemurafenib and cobimetinib therapy as determined by treating physician.
    - Pazienti con melanoma confermato istologicamente, Stadio IIIc non resecabile o Stadio IV, come definito dall’American Joint Committee on Cancer 7° edizione;
    - Pazienti non trattati precedentemente per melanoma metastatico;
    - Documentazione di stato mutazionale positivo per BRAFV600 nel tessuto tumorale del melanoma (di archivio oppure ottenuto ex-novo) tramite test mutazionale validato;
    - Performance status adeguato a ricevere la terapia con vemurafenib o cobimetinib a giudizio del medico che ha in cura il paziente.
    E.4Principal exclusion criteria
    Cancer-related exclusion criteria:
    1. Palliative radiotherapy within 7 days prior to the first dose of program treatment.
    2. Patients with active malignancy (other than BRAF-mutated melanoma) or a previous malignancy within the past 3 years except for patients with resected melanoma, resected BCC, resected cutaneous SCC, resected melanoma in situ, resected carcinoma in situ of the cervix, and resected carcinoma in situ of the breast.
    Exclusion criteria based on organ function:
    Ocular:
    3. Evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment / central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration.
    4. Systemic risk factor for RVO including uncontrolled glaucoma, uncontrolled hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
    Cardiac:
    5. History of clinically significant cardiac dysfunction, including the following:
    a) Current unstable angina.
    b) Symptomatic congestive heart failure of New York Heart Association class 2 or higher.
    c) History of congenital long QT syndrome or mean (average of triplicate measurements) QTcF = 450 msec at baseline; presence of clinically significant ventricular or atrial dysrhythmias = Grade 2.
    d) Uncontrolled hypertension = Grade 2 (patients with a history hypertension controlled with anti-hypertensives to = Grade 1 are eligible).
    e) Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower.
    General exclusion criteria:
    6. Current severe, uncontrolled systemic disease.
    7. Major surgery or traumatic injury within 14 days prior to first dose of program treatment.
    8. History of malabsorption or other condition that would interfere with absorption of program drugs.
    9. Hypersensitivity to the active substance or to any of the excipients.
    10. Pregnant or breastfeeding women.
    Criteri di esclusione correlati al tumore:
    1.Radioterapia palliative nei 7 giorni precedenti la somministrazione della prima dose di trattamento in studio.
    2. Pazienti con patologia maligna attiva (diversa dal melanoma con mutazione di BRAF) o pregressa patologia maligna nei 3 anni precedenti ad eccezione dei pazienti con melanoma resecato, BCC resecato, SCC cutaneo resecato, melanoma in situ resecato, carcinoma in situ della cervice resecato e carcinoma mammario in situ resecato.
    Criteri di esclusione basati sulla funzionalità d’organo:
    Oculari:
    3. Evidenza di patologia retinica all’esame oftalmologico che sia considerata come un fattore di rischio per distacco della retina neurosensoriale / corioretinopatia sierosa centrale (Central Serous Chorioretinopathy - CSCR) / occlusione venosa retinica (Retinal Vein Occlusion - RVO), o degenerazione maculare neovascolare.
    4. Fattore di rischio sistemico per RVO compresi glaucoma non controllato, ipercolesterolemia non controllata, ipertrigliceridemia o iperglicemia.
    Cardiaci:
    5. Anamnesi di disfunzione cardiaca clinicamente significativa, compresi i seguenti:
    a) Attuale angina instabile
    b) Scompenso cardiaco congestizio sintomatico di classe New York Heart Association 2 o superiore
    c) Anamnesi di sindrome congenita del QT lungo o QTcF medio (media di triplice misurazione) = 450 msec al basale; presenza di aritmie ventricolari o atriali clinicamente significative = Grado 2
    d) Ipertensione non controllata = Grado 2 (i pazienti con anamnesi di ipertensione controllata con anti-ipertensivi a = Grado 1 sono eleggibili)
    e) Frazione di eiezione ventricolare sinistra (Left Ventricular Ejection Fraction – LVEF) al di sotto del limite di normalità inferiore (Lower Limit of Normal – LLN) istituzionale o inferiore al 50%, a seconda di quale dei due sia più basso
    Criteri di esclusione generali:
    6. Attuale patologia sistemica severa non controllata
    7. Intervento chirurgico maggiore o danno traumatico nei 14 giorni precedenti la somministrazione della prima dose di trattamento in studio.
    8. Anamnesi di malassorbimento o altra condizione che può interferire con l’assorbimento dei trattamenti in studio.
    9. Ipersensibilità alla sostanza attiva o ad uno qualsiasi dei suoi eccipienti.
    10. Donne in gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is Overall Survival (OS) for patients with focal progression.
    L’endpoint primario è la sopravvivenza globale (Overall Survival – OS) per i pazienti con progressione focale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the day of randomization to the day of death from any cause.
    Dal giorno della randomizzazione al giorno della morte per qualsiasi causa.
    E.5.2Secondary end point(s)
    Progression Free Survival (PFS) for patients with focal progression. ; OS for patients with non-focal progression.; Prognostic role in terms of OS of focal compared with non-focal progressive disease. ; Safety based on the following variables: Nature, frequency, severity, and timing of adverse events and serious adverse events; Changes in vital signs, physical findings and clinical laboratory results during and following vemurafenib + cobimetinib administration.
    Sopravvivenza libera da progressione (Progression Free Survival - PFS) per i pazienti con progressione focale.; OS per i pazienti con progressione non focale.; Ruolo prognostico in termini di OS di malattia progressiva focale rispetto a non focale ; Sicurezza basata sulle seguenti variabili: Natura, frequenza, severità e tempistiche degli eventi avversi e degli eventi avversi seri; variazioni nei segni vitali, negli esiti fisici e nei risultati di laboratorio clinico durante e dopo la somministrazione di vemurafenib + cobimetinib.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the day of randomization to the day of disease progression or death from any cause.; During the study; During the study; During the study
    Dal giorno della randomizzazione al giorno della progressione della malattia o della morte per qualsiasi causa.; Durante lo studio; Durante lo studio; Durante lo studio
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned13
    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 Information not present in EudraCT
    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
    The end of the study will occur when all patients have been followed up for survival for 24 months after the last patient has been randomized, or after the last dose of vemurafenib and cobimetinib (for non-randomized patients).
    La fine dello studio si verificherà quando tutti i pazienti saranno stati osservati per la sopravvivenza per 24 mesi dopo la randomizzazione dell’ultimo paziente o dopo l’ultima dose di vemurafenib e cobimetinib (per i pazienti non randomizzati).
    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 months2
    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 months2
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Immunotherapy and other treatments for metastatic melanoma; best supportive care.
    Immunoterapia e altri trattamenti per il melanoma metastatico; best supportive care.
    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 Decision2017-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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