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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 - BeyPro2

Studio Clinico

Patologia: Melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea, Seconda linea

Criteri di inclusione: 

- 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
- Male or female patient aged ≥18 years
- Able to participate and willing to give written informed consent prior to any treatment-related procedures and to comply with treatment guidance
- Adequate end-organ function, defined by the following laboratory results obtained within 14 days prior to the first dose of program drug treatment:
 1. Bilirubin ≤ 1.5 x the upper limit of normal (ULN).
 2. AST, ALT, and alkaline phosphatase ≤ 3 x ULN, with the following exceptions:
    - Patients with documented liver metastases: AST and/or ALT ≤ 5 x ULN.
    - Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN.
 3. Serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min based on measured CrCl from a 24-hour urine collection or Cockroft-Gault glomerular filtration rate estimation.
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective forms of contraception during program therapy and for at least 6 months after completion of program therapy
- Negative serum pregnancy test prior to commencement of dosing in women of childbearing potential
- Patient should be able to swallow tablets
- Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the treatment regimen
- Patient does not currently participate in other clinical trials

Criteri di esclusione: 

- Palliative radiotherapy within 7 days prior to the first dose of program treatment
- 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
- 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
- Systemic risk factor for RVO including uncontrolled glaucoma, uncontrolled hypercholesterolemia, hypertriglyceridemia or hyperglycemia
- History of clinically significant cardiac dysfunction, including the following:
 1. Current unstable angina.
 2. Symptomatic congestive heart failure of New York Heart Association class 2 or higher.
 3. 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.
 4. Uncontrolled hypertension ≥ Grade 2 (patients with a history hypertension controlled with anti-hypertensives to ≤ Grade 1 are eligible).
 5. Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower
- Current severe, uncontrolled systemic disease
- Major surgery or traumatic injury within 14 days prior to first dose of program treatment
- History of malabsorption or other condition that would interfere with absorption of program drugs
- Hypersensitivity to the active substance or to any of the excipients
- Pregnant or breastfeeding women

Trattamento sperimentale: 

Experimental combination beyond Focal Progression

Local treatment (i.e. surgery, radiotherapy) + Vemurafenib 240mg tablets (4 tabs/twice daily for 28 consecutive days) + Cobimetinib 20mg tablets (3 tabs/day for 21 consecutive days) beyond focal progression

Trattamento di controllo: 

Pembrolizumab or Nivolumab

Pembrolizumab daily dose 2 mg/kg milligram(s)/kilogram or Nivolumab daily dose 3 mg/kg milligram(s)/kilogram.

Obiettivi primari dello studio: 

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

Centri partecipanti

Nord Italia

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG

Riferimento: Dr. Mario Mandalà
Email: mmandala@asst-pg23.it

 

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

Riferimento: Dr.ssa Barbara Melotti
Telefono: 0512142203
Email: barbara.melotti@aosp.bo.it

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Massimo Guidoboni
Email: massimo.guidoboni@irst.emr.it

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

Riferimento: Dr. Francesco Spagnolo
Telefono: 0105558901
Email: francesco.spagnolo@hsanmartino.it

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Dr. Michele Del Vecchio
Email: michele.delvecchio@istitutotumori.mi.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr.ssa Vanna Chiarion Sileni
Telefono: 0498215938
Email: vanna.chiarion@ioveneto.it

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
Presidio San Lazzaro - Via Cherasco 21/23

Riferimento: Prof.ssa Maria Teresa Fierro
Email: mariateresa.fierro@unito.it

 

Centro Italia

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

Riferimento: Alfredo Falcone
Telefono: 050992466

 

Istituto Dermopatico dell'Immacolata
Via Monti di Creta 104 - 00167 Roma - RM

Riferimento: Dr.ssa Federica De Galitiis
Email: oncologia.idi@idi.it

 

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

Riferimento: Dr.ssa Virginia Ferraresi
Telefono: 0652666773
Email: virginia.ferraresi@ifo.gov.it

 

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI

Riferimento: Dr.ssa Anna Maria Di Giacomo
Telefono: 0577586336

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

Riferimento: Dr. Michele Guida
Telefono: 0805555363

 

Presidio Ospedaliero San Vincenzo di Taormina
Contrada Sirina - 98039 Taormina - ME

Riferimento: Dr. Francesco Ferraù
Telefono: 0942579282
Email: ferrau@oncologiataormina.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03514901

Data di inserimento: 08.04.2019

Data di aggiornamento: 09.09.2019

Promotore

CRO

OPIS

Principal Investigator ITALIA

Riferimento: Dr.ssa Paola Queirolo

Telefono: 0257489459

Email: paola.queirolo@ieo.it

Localita: Milano

 

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