EQUENTIAL THERAPY WITH VEMURAFENIB AND ELECTROCHEMOTHERAPY FOR IN-TRANSIT MELANOMA METASTASES

Phase 1

• Conditions: melanoma BRAF V600 mutated; MedDRA version: 21.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004960-12-IT
• Lead Sponsor: INTERGRUPPO MELANOMA ITALIANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-30
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 53

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified