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
- Conditions
- 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
- Registration Number
- DRKS00024401
- Lead Sponsor
- Hautkrebszentrum Buxtehude Elbekliniken Stade Buxtehude
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
• 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To explore the feasibility of and satisfaction with the Kaiku Health Digital Health Intervention (DHI) platform for patient-management also with regard to detection of early symptoms of immune-related adverse events
- Secondary Outcome Measures
Name Time Method