Feasibility study on electronically aided patient management Kaiku Health” to improve early detection of adverse events in melanoma patients under immune-oncology (IO) combination therapy - Nivo Ipi ePROM

Hautkrebszentrum Buxtehude Elbekliniken Stade Buxtehude0 个研究点目标入组 20 人开始时间: 2021年2月25日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Advanced (unresectable or metastatic) melanoma arising from a primary cutaneous site or metastatic from an unknown primary site or melanoma of mucosal or uveal origin that are suitable to receive IO combination therapy (Ipilimumab + Nivolumab) in any line of treatment.
•Age = 18 years
•Indication for combination therapy with nivolumab and ipilimumab according to SmPC
•Patients have a smartphone or computer
•Willing to use the DHI platform tool
•Be able to communicate in German language
•Life expectancy of at least 3 months
•Men with female partners of childbearing potential and women of childbearing potential (WOCBP) should use effective contraception during combination immunotherapy and for at least 5 months following the last dose of nivolumab
•Patients are legally competent and able to understand the nature, risks, significance and scope of the study and to determine his or her will accordingly
•Signed written informed consent

•Hypersensitivity to the active substance(s) and to any of the excipients of nivolumab and ipilimumab
•For WOCBP: Pregnancy or lactation period
•Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
•Known alcohol or drug abuse
•Significant disease which, in the investigator’s opinion, would exclude the patient from the study
•Patients are not legally competent and not able to understand the nature, risks, significance and scope of the study and to determine his or her will accordingly

发起方

Hautkrebszentrum Buxtehude Elbekliniken Stade Buxtehude