Melanoma
Conditions
Interventions
Blood sampies will be collected before the start of therapy. Peripheral blood mononuclear cells (PBMCs) will be isolated and the lOpenerO-melanoma score will be calculated using Standard procedures.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Unresectable stage III or stage IV cutaneous melanoma for whom treatment with immune checkpoint inhibitors (ICIs) is considered by the treating physician. • Inclusion of patients with brain metastases is permitted if the metastases are asymptomatic or have been treated. • Anticipated life expectancy exceeding 3 months. • Aged 18 years or older and written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: • Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors or immunotherapy. • Serum LDH > 2x ULN. • Presence of symptomatic brain metastases. • WHO performance score > 2. • (Neo)adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months. • Patients undergolng other experimental treatments or therapies that may interfere with the immunotherapy's mechanism of action or assessment of lts effects might be excluded. • Pregnant, lactating, or breast-feeding women. • Presence of any medical or other conditiën that in the opinion of the investigator(s) would preclude the participation in a clinical study. • Unwillingness or inability to comply with study and follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 1-Year PFS (proportion of patients with Progression Free Survival ^ 1 year) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Disease Contrei Rate (DCR, "clinical benefit”), based on Best Overall Response according to RECIST 1.1 • Occurrence of irAEs according to the CTCAE version 5.0 • Overall response Rate (ORR) based on Best Overall Response according to RECIST 1.1 • Overall Survival (OS) • Clinical and pathological factors prognostic for response, PFS, OS (e.g. LDH, number and site of metastases, WHO status) • Quality of life (QoL) • Treatment costs, including (hospitaiization) costs, associated with adverse events | — |
Countries
Netherlands
Contacts
Public ContactH.W. Kapiteijn
Leids Universitair Medisch Centrum
Outcome results
None listed