C43
Conditions
Interventions
Group 1: For this case register study, data about anti-PD 1 antibody treatment, following treatment and Follow-up every 3 months will be collected. Follow-up will be end 24 months after start of treat
Sponsors
Elbekliniken Buxtehude, Skin Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - primary diagnosis of advanced melanoma (Stage III [unresectable] or Stage IV skin, ocular, or mucosal melanoma) - Histologically confirmed diagnosis - At least 18 years of age at time of treatment decision - Ipilimumab naive patient with subsequent therapy after first line anti-PD-1 therapy failure
Exclusion criteria
Exclusion criteria: - Patients with a current primary diagnosis of a cancer other than advanced melanoma - Ipilimumab therapy prior to anti PD-1 treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the end of follow-up (12 months after the latest index date (index date =start of treatment following anti PD-1 antibody treatment) when all patients have been included in the register study) the final analysis is planned. Objective responses will be classified as complete (CR) or partial remissions (PR) together giving the objective response rate (OR). This will be calculated with according 95 percent confidence intervals and tabulated for the total population treated with ipilimumab. In addition, time to response will be described as well as duration of response. | — |
Secondary
| Measure | Time frame |
|---|---|
| - progression free survival (PFS) and overall survival (OS) | — |
Countries
Germany
Contacts
Public ContactJessica Behne
ONKODATAMED GmbH
Outcome results
None listed