A multicenter phase II study evaluating the efficacy and tolerability of vemurafenib in combination with Pegylated Interferon and Interleukin-2 in patients with BRAF-mutated metastatic melanoma - vem+IL-2

Department of Oncology, Aarhus University Hospital0 sites50 target enrollmentJuly 12, 2013

Overview

No summary available.

Registry

who.int

Start Date

July 12, 2013

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Department of Oncology, Aarhus University Hospital

•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

•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