- - Advanced/metastatic melanoma.
- - Scheduled for treatment with ipilimumab.
- - Histological or cytological documentation of cancer is required.
- - WHO Performance Status of 0 or 1.
- - At least 1 measurable lesion.
- - Signed informed consent must be obtained prior to any study procedures.
- - Patients must be able to adhere to the study appointments and other protocol
- - Previous exposure to ipilimumab.
- - Pregnant or breast-feeding subjects.
Women of childbearing potential must have a
negative pregnancy test performed within 7 days of the start treatment. Both men and
women enrolled in this trial must agree to use adequate barrier birth control measures
(e.g. cervical cap, condom and diaphragm) during the course of the trial. Oral birth
control methods alone will not be considered adequate on this study, because of the
potential pharmacokinetic interaction between study drug and oral contraceptives.
Concomitant use of oral and barrier contraceptives is advised. Contraception is
necessary for at least 6 months after receiving study drug.
- - Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy
during the study or within 4 weeks after starting the study drug.
- - Radiotherapy of target lesions during study or within 4 weeks after starting the study
Palliative radiotherapy will be allowed.
- - Major surgery within 28 days of start of study drug.
- - Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results.
- - Any condition that is unstable or could jeopardize the safety of the subject and their
compliance in the study.