Colchicine for Atherosclerosis | Cancer

Inclusion criteria

• {"criterion_text":"- Age 50 years or older"}
• {"criterion_text":"- Planned for treatment with a PD-1 or PD-L1 inhibitor for at least 3 months"}
• {"criterion_text":"- Signs of atherosclerosis on imaging (e.g. coronary artery calcium score >0 on cancer staging chest CT-scan or calcifications of aorta, abdominal arteries, or iliac arteries abdomino/pelvic CT-scan)"}

Exclusion criteria

• {"criterion_text":"- Chest radiation therapy in prior 3 months (or planned during the study)"}
• {"criterion_text":"- Moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2 based on CKD-EPI)"}
• {"criterion_text":"- Child Pugh B or C liver cirrhosis"}
• {"criterion_text":"- Known intolerance to colchicine"}
• {"criterion_text":"- Use of immunosuppressive medication at randomization"}
• {"criterion_text":"- Use of strong CYP3A4 inhibitors"}
• {"criterion_text":"- Colchicine use in previous <3 months"}
• {"criterion_text":"- Indication for long-term treatment with colchicine"}
• {"criterion_text":"- Inability to provide written informed consent"}

Primary endpoints

• {"endpoint_text":"- Change in maximum target-to-background ratio (TBRmax) in coronary arteries, which quantifies 68Gallium-DOTATATE uptake, between baseline and 12-week follow-up on PET-scan.","definition_or_measurement_approach":"Change in TBRmax in coronary arteries measured by 68Gallium-DOTATATE PET-scan between baseline and 12-week follow-up."}

Secondary endpoints

• {"endpoint_text":"- TBRmax in carotid arteries","definition_or_measurement_approach":"TBRmax measured by PET-scan in carotid arteries."}
• {"endpoint_text":"- TBRmax in aorta","definition_or_measurement_approach":"TBRmax measured by PET-scan in aorta."}
• {"endpoint_text":"- Mean standardized uptake value (SUVmean) in spleen","definition_or_measurement_approach":"Mean standardized uptake value (SUVmean) measured by PET-scan in spleen."}
• {"endpoint_text":"- SUVmean in bone marrow","definition_or_measurement_approach":"Mean standardized uptake value (SUVmean) measured by PET-scan in bone marrow."}
• {"endpoint_text":"- Coronary artery calcium score","definition_or_measurement_approach":"Coronary artery calcium scoring on CT imaging."}
• {"endpoint_text":"- Major adverse cardiovascular events (i.e. myocardial infarction, ischemic stroke, ischemia-driven coronary revascularisation, death)","definition_or_measurement_approach":"Composite of myocardial infarction, ischemic stroke, ischemia-driven coronary revascularisation, and death as clinical event endpoints."}
• {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":"Death from any cause."}
• {"endpoint_text":"- Immune related adverse events","definition_or_measurement_approach":"Recording and classification of immune-related adverse events (as per protocol safety assessments)."}
• {"endpoint_text":"- Biomarkers (e.g. blood inflammatory markers, PBMCs, plasma cytokines, metabolomics, and microbiome composition)","definition_or_measurement_approach":"Measurement of listed blood and microbiome biomarkers using laboratory assays (blood inflammatory markers, PBMC profiling, plasma cytokines, metabolomics) and microbiome composition analyses."}

Netherlands

Earliest CTIS Part Ii Submission Date

24-02-2025

Latest Decision Or Authorization Date

08-04-2025

Processing Time Days

43

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands