PEMBROLIZUMAB for Cutaneous melanoma | Advanced (stage III/IV) cutaneous melanoma

Inclusion criteria

• {"criterion_text":"- Unresectable stage III or stage IV cutaneous melanoma for whom treatment with immune checkpoint inhibitors (ICIs) is considered by the treating physician.\n- Inclusion of patients with brain metastases is permitted if the metastases are asymptomatic or have been treated.\n- Anticipated life expectancy exceeding 3 months.\n- Aged 18 years or older and written informed consent for participation in the study."}

Exclusion criteria

• {"criterion_text":"- Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors or immunotherapy\n- Serum LDH >2x ULN.\n- Presence of symptomatic brain metastases\n- WHO performance score > 2.\n- (Neo)adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.\n- Patients undergoing other experimental treatments or therapies that may interfere with the immunotherapy's mechanism of action or assessment of its effects might be excluded.\n- Pregnant, lactating, or breast-feeding women.\n- Presence of any medical or other conditiën that in the opinion of the investigator(s) would preclude the participation in a clinical study.\n- Unwillingness or inability to comply with study and follow-up procedures"}

Primary endpoints

• {"endpoint_text":"- • 1-Year PFS (proportion of patients with Progression Free Survival ^ 1 year)","definition_or_measurement_approach":"Proportion of patients with Progression Free Survival at 1 year (as stated: \"proportion of patients with Progression Free Survival ^ 1 year\")."}

Secondary endpoints

• {"endpoint_text":"- Disease Control Rate (DCR, \"clinical benefit”), based on Best Overall Response according to RECIST 1.1","definition_or_measurement_approach":"DCR based on Best Overall Response assessed according to RECIST 1.1 (sensitivity, specificity, PPV, NPV will be evaluated)."}
• {"endpoint_text":"- overal response Rate (ORR) based on Best Overall Response according tot RECIST 1.1","definition_or_measurement_approach":"ORR based on Best Overall Response assessed according to RECIST 1.1."}
• {"endpoint_text":"- overall survival (OS) and progression free survial (PFS)","definition_or_measurement_approach":"Overall survival (OS) and progression-free survival (PFS) as time-to-event endpoints (definitions not further specified in available text)."}
• {"endpoint_text":"- Quality of Life (QoL) using EQ-5D-5L","definition_or_measurement_approach":"Quality of life assessed using the EQ-5D-5L instrument."}
• {"endpoint_text":"- Medical Costs","definition_or_measurement_approach":"Medical costs to be measured/analysed (methodology not specified in available text)."}

Netherlands

Earliest CTIS Part Ii Submission Date

17-07-2025

Latest Decision Or Authorization Date

25-07-2025

Processing Time Days

8

Number Of Sites

2

Number Of Participants

96

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Pamgene","duties_or_roles":"Monetary support","organisation_type":""}