Authorised Therapeutic confirmatory (Phase III) Atherosclerosis

Colchicine to inhibit atherosclerosis in patients with cancer receiving immune therapy

EU CTIS ID: 2024-518100-45-00

What this study is testing

To evaluate the effect of colchicine on coronary vessel wall inflammation

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age 50 years or older
  • Planned for treatment with a PD-1 or PD-L1 inhibitor for at least 3 months
  • 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)

You likely can't join if

  • Chest radiation therapy in prior 3 months (or planned during the study)
  • Moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2 based on CKD-EPI)
  • Child Pugh B or C liver cirrhosis
  • Known intolerance to colchicine
  • Use of immunosuppressive medication at randomization
  • Use of strong CYP3A4 inhibitors
See the full eligibility criteria
Who can join
  • Age 50 years or older
  • Planned for treatment with a PD-1 or PD-L1 inhibitor for at least 3 months
  • 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)
What rules you out
  • Chest radiation therapy in prior 3 months (or planned during the study)
  • Moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2 based on CKD-EPI)
  • Child Pugh B or C liver cirrhosis
  • Known intolerance to colchicine
  • Use of immunosuppressive medication at randomization
  • Use of strong CYP3A4 inhibitors
  • Colchicine use in previous <3 months
  • Indication for long-term treatment with colchicine
  • Inability to provide written informed consent

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.