melanoma BRAF V600 mutated MedDRA version: 21.1 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ZELBORAF - 240 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) 56 COMPRESSE
Product Name: Zelboraf
Product Code: EU/1/12/751/001
Pharmaceutical Form: Film-coated tablet
Sponsors
INTERGRUPPO MELANOMA ITALIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of melanoma BRAF V600 mutated with in-transit metastases not amenable to excision and confined to a limb; 2. Presence of instrumentally or clinically measurable or evaluable lesions; 3. Patients who at the judgement of an expert surgical team are candidate to electrochemotherapy; 4. Age > 18 with PS ¿ 2 (ECOG); 5. Life expectancy > 6 months; 6. Blood tests (hemochromocitometric exam, hepatic and renal function) within the norm or with values not more than 50% above the normal range; 7. Absence of metabolic, endocrine or neurological diseases that require continuous drug therapy; 8. Absence of other malignant tumors, excluding carcinoma in situ of the cervix and radically resected early skin cancer; 9. Staging carried out within 30 days of randomization; 10. Geographical accessibility; 11. Written informed consent (including the suggested use of contraceptives for premenopausal women). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. Patients with locally advanced disease judged not to be suitable for electrochemotherapy; 2. Absence of measurable or evaluable lesions; 3. Performance Status: ECOG ¿ 3; 4. Patients previously treated with a BRAF inhibitor; 5. Patients treated with a MEK inhibitor; 6. Presence of a concomitant second tumour. Patients with a previous malignancy but without evidence of disease for = 3 years will be allowed to enter the trial; 7. Patients with QTc >450 msec on screening ECG, history of congenital long QT syndrome, or uncorrectable electrolytes abnormalities 8. Presence of metabolic, endocrine or neurological diseases that require continuous drug therapy; 9. Blood tests (hemochromocitometric exam, renal and hepatic function) with values 50% higher or lower than the normal ranges, and/or total bilirubinemia > 2 X ULN; 10. Previous or ongoing serious cardiovascular diseases; 11. Absence of written informed consent; 12. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent; 13. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To detect progression free survival of an oral BRAF inhibitor (Vemurafenib) in combination with electrochemotherapy for melanoma patients with in-transit recurrence suitable to be treated with electrochemotherapy.;Secondary Objective: •Overall response rate •Overall survival •Safety evaluation •Quality of life: QLQ-C30 and EQ-5D questionnaires Exploratory Objectives The general objective of the translational studies is to identify positive and negative biomarkers predictive of clinical outcome in tissue specimens of in-transit metastases taken before and after BRAF inhibitor therapy. Hence, the below reported biomarkers will be correlated with ORR, PFS, OS. Upon surgical excision, half of each tissue from the in-transit metastasis will be immediately snap-frozen while the other half will be formalin-fixed and paraffin-embedded for conventional histopathological examination and subsequent immunohistochemical and molecular analyses. ;Primary end point(s): •Progression-Free-Survival (PFS), defined as the time from study registration and the date of first observed disease progression or death due to any cause, if death occurs before progression is documented.;Timepoint(s) of evaluation of this end point: ate of first observed disease progression or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Response Rate (ORR) defined as the proportion of patients achieving a complete or partial response during the treatment. ORR will be evaluated according to RECIST Criteria version 1.1. The tumor response rate will be defined as the total number of subjects whose best response is partial or complete response, divided by the number of enrolled subjects.; Overall Survival (OS), defined as the time from study registration and the date of death for any cause, or the last date the patient is known to be alive ;Timepoint(s) of evaluation of this end point: last visit of the last patient enrolled; last visit of the last patient enrolled | — |
Countries
Italy
Contacts
Public ContactUSC Oncologia Medica
ASST-Papa Giovanni XXIII
Outcome results
None listed