Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Inge Marie Svane
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed unresectable stage III or stage IV metastatic melanoma.
Metastasis available for surgical resection (about 2 cm3) and residual measureable disease after resection.
Pathologically verified BRAF mutation.
ECOG performance status 0-1.
Life expectancy ≥ 3 months.
No significant toxicity (CTC ≤ 1) from prior treatments.
Adequate renal, hepatic and hematologic function.
Women of childbearing potential (WOCBP) and men in a sexual relationship with a WOCBP must be using an effective method of contraception during treatment and for at least 6 months after completion of treatment.
Able to comprehend the information given and willing to sign informed consent.
You may not be if
Other malignancies, unless followed for ≥ 5 years with no sign of disease, except squamous cell carcinoma or adequately treated carcinoma in situ colli uteri.
Cerebral metastasis. Patients with previously treated CNS metastasis can participate if surgically removed or treated with stereotactic radiotherapy if stable \> 28 days after treatment measured by MRI. Patients with asymptomatic and untreated CNS metastasis can participate based on investigators evaluation.
Patients with ocular melanoma.
Previous treatment with a BRAF inhibitor.
Severe allergies, history of anaphylaxis or known allergies to drugs administered.
Serious medical or psychiatric comorbidity.
QTc ≥ 450 ms.
Clearance \< 70 ml/min.
Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis
Active autoimmune disease.
Pregnant og nursing women.
Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate.
Concomitant treatment with other experimental drugs.
Patients with uncontrolled hypercalcemia
More than four weeks must have elapsed since any prior systemic therapy at the time of treatment
