A multicenter phase II study evaluating the effect and tolerability of vemurafenib in combination with Pegylated Interferon and Interleukin-2 in patients with metastatic melanoma positive for the BRAF-mutatio

Phase 1

• Conditions: Metastatic melanoma; MedDRA version: 16.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000773-71-DK
• Lead Sponsor: Department of Oncology, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-12
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Histologically verified unresectable stage III or stage IV melanoma with documented BRAF V600 mutation determined by the cobas® 4800 BRAF mutation test
•Age between 18 and 70
•ECOG performance status (PS) 0-2
•Patients must have measurable target lesions disease as defined by RECIST v1.1
•Prior medical treatment for metastatic melanoma is allowed, except previous treatment with BRAF-inhibitor and IL-2 based immunotherapy
•Adequate cardiac function (less or equal to NYHA II). In the case of previous myocardial infarction echocardiography or MUGA-scan must be performed and left ventricle ejection fraction must be found normal
•Adequate hematologic, renal and liver function as defined by laboratory values performed within 2 weeks of enrolment:
oAbsolute neutrophil count (ANC) = 1.5 x 109/L
oPlatelet count = 100 x 109/L
oSerum creatinine = 1.5 times upper limit of normal (ULN) or - creatinine clearance (CrCl) > 50 mL/hr by Cockroft–Gault formula
oAlanine aminotransferase (ALAT) = 2.5 times ULN (= 5 times ULN if considered due to liver metastasis)
oSerum bilirubin = 1.5 times ULN
oAlkaline phosphatase = 2.5 times ULN (= 5 times ULN if considered due to liver metastasis)
•Patients must have absence of any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of the study drugs hazardous or obscure the interpretation of adverse events
•Fertile men and women must be using an effective method of contraception during treatment and for at least one month after completion of treatment
•Women of child-bearing potential (WOCBP) must have a negative pregnancy test (HCG-urinalysis) before trial entry
•Signed informed consent must be obtained prior to performing any study-related procedures. Testing for the V600 BRAF-mutation is considered as a standard procedure

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 10

Exclusion Criteria

•Any known severe and symptomatic autoimmune diseases that upon the opinion of the Investigators may conflict with the administration of the study medication.
•Cerebral metastases. Patients that have been radically treated (neurosurgery or stereotactic radiotherapy) for a solitary cerebral metastasis may be included if MRI of the brain performed at least one month after treatment is without evidence of disease activity
•Patients must not be dependent on systemic treatment with corticosteroids or other immunosuppressing agents
•Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that may compromise adequate absorption. Patients must be able to swallow tablets
•Uncontrolled infectious disease (requiring treatment with intravenous antibiotics)
•Second malignancy in the past 5 years with the exception of surgically cured carcinoma in situ of the cervix or basal and squamous cell carcinoma of the skin.
•QTc-interval > 500 ms
•Any psychological, familial, sociological or geographical condition that upon the opinion of the investigators may affect the compliance with the protocol and follow-up schedule

Study & Design

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