ptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastatic melanoma - 89Zirconium-ipilumumab

VU medical center0 个研究点目标入组 24 人开始时间: 2015年8月18日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•Advanced/metastatic melanoma
•oScheduled for treatment with combination treatment of nivolumab and ipilimumab.
•oAge = 18 years.
•oHistological or cytological documentation of cancer is required.
•oWHO Performance Status of 0 or 1.
•oAt least 1 measurable lesion.
•oSigned informed consent must be obtained prior to any study procedures.
•oPatients must be able to adhere to the study appointments and other protocol requirements.
•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 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•oPrevious exposure to ipilimumab or nivolumab.
•oPregnant 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.
•oConcurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks after starting the study drug.
•oRadiotherapy of target lesions during study or within 4 weeks after starting the study drug. Palliative radiotherapy will be allowed.
•oMajor surgery within 28 days of start of study drug.
•oSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
•oAny condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

发起方

VU medical center