Pembrolizumab for Cancer (all types)

Inclusion criteria

• {"criterion_text":"- ≥18 yr.\n- Diagnosed with any oncological disease with or without pre-existing auto-immune disease\n- Starting with ICI therapy (ICI therapy defined as treatment with anti-PD1, anti-PDL1, anti-CTLA-4 or newly registered immune checkpoint therapies, either in mono- or combination therapy)"}

Exclusion criteria

• {"criterion_text":"- Previous treatment with ICI therapy."}

Primary endpoints

• {"endpoint_text":"- The differentiation and quantification of the (relative) frequency of different immune-cell subsets* in the peripheral blood (and potentially other biomaterials)","definition_or_measurement_approach":"Measurement of immune-cell subset frequencies in peripheral blood and potentially other biomaterials (immunophenotyping)."}
• {"endpoint_text":"- The quantification of immune activity of the defined immune-cell subsets* by performing in vitro functional assays.","definition_or_measurement_approach":"In vitro functional assays to quantify immune activity of defined immune-cell subsets."}
• {"endpoint_text":"- The evaluation of the specific incidence, serological profiles and response to treatment of patients both with and without preexisting disease and starting ICI therapy and those developing irAE’s.","definition_or_measurement_approach":"Evaluation of incidence, serological profiles and treatment response in patients starting ICI therapy, comparing those with and without preexisting disease and those developing irAEs."}

Secondary endpoints

• {"endpoint_text":"- Disease activity and its progression over time were evaluated using disease-specific scoring metrics and the frequency, time of onset, duration, and severity (grade) of flares were recorded.","definition_or_measurement_approach":"Use of disease-specific scoring metrics; recording frequency, onset time, duration and grade of flares."}
• {"endpoint_text":"- The absolute change and fold-change in frequency of different immune-cell subsets* in the peripheral blood (and potentially other biomaterials) of R-irAE or N-irAE patients during immunosuppressive therapy.","definition_or_measurement_approach":"Measurement of absolute and fold-change in immune-cell subset frequencies in peripheral blood and other biomaterials during immunosuppressive therapy."}
• {"endpoint_text":"- The immunohistochemical phenotype (determined in blood, synovial fluid and synovial tissue) of specifically R-irAE arthritis compared to classical RA.","definition_or_measurement_approach":"Immunohistochemical profiling of blood, synovial fluid and synovial tissue to compare R-irAE arthritis with classical RA."}
• {"endpoint_text":"- The qualitative comparison of whole body [18F]FDG PET/CT imaging of R-irAE arthritis patients with classical RA patients. The study endpoints are defined as: the standardized uptake value (SUV) metrics (SUVmax, SUVpeak and SUVmean) of the joints, muscles/muscle insertions and lymphoid organs and the biodistribution of the tracer - SUV metrics of certain organs at interest, such as the liver, spleen, bone marrow, heart, kidneys etc.","definition_or_measurement_approach":"Whole-body [18F]FDG PET/CT comparison using SUV metrics (SUVmax, SUVpeak, SUVmean) in joints, muscles, lymphoid organs and specified organs to assess biodistribution and extent of inflammatory activity."}

Netherlands

Latest Decision Or Authorization Date

22-01-2026

Number Of Sites

4

Number Of Participants

495

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands