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
Conditions
Interventions
Group 1: The patients of the non-interventional study receive combination therapy with nivolumab and ipilimumab in routine clinical practice according to the current product information. The study doe
Sponsors
Hautkrebszentrum Buxtehude Elbekliniken Stade Buxtehude
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • To determine compliance and differences in compliance between patients that report symptoms (Grade 1-2;3;4) and patients that do not report any symptoms • To determine the concordance of immune-related adverse events (irAEs) as documented by the site and outcome of Digital Health Intervention platform as reported by patient • To analyze the cut-off-value for general well-being which triggers filling-in of the 18 item-questionnaire • To determine satisfactory of medical team with teaching and using the Digital Health Intervention platform by an additional satisfactory questionnaire • To determine reasons of patients that do not want to use the Digital Health Intervention platform • To define treatment specific evidence-based transition points such as the time to symptom occurrence after given therapy cycle and compare these with literature values • To determine additional endpoints for a potential subsequent randomized trial • To explore the correlation of patient-reported symptoms with immune-related adverse events, laboratory results and treatment response as assessed by the investigator during clinical routine and the feasibility of machine learning based model for predicting the onset of irAE based on patients’ symptom reports combined with clinical data | — |
Countries
Germany
Contacts
Public ContactPeter Mohr
Elbekliniken Stade Buxtehude
Outcome results
None listed