Home microsampling to monitor cancer drug levels

Microsampling to Facilitate Drug Monitoring of Oncolytics

This tests whether tiny blood samples taken at home can reliably measure levels of certain oral and injectable cancer drugs in adults using those medicines.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Drugs / interventions: Nivolumab, Ipilimumab, Pembrolizumab, Atezolizumab, Bevacizumab, Enfortumab, Cabozantinib, Sunitinib, Lenvatinib, Imatinib
• Locations: 1 site (Leiden, South Holland)
• Trial ID: NCT06545292 on ClinicalTrials.gov

What this trial studies

The study clinically validates an analytical method using dried blood spot microsampling to measure concentrations of a panel of oral targeted therapies and several monoclonal antibodies. It also tests the feasibility of patients collecting capillary samples at home for therapeutic drug monitoring. The rationale is that many oral oncolytics show large between-patient variability in blood levels, which can lead to under- or overdosing, and that convenient home sampling could reduce clinic burden and support personalized dosing. Microsampling of immune checkpoint inhibitors remains exploratory within this protocol.

Who should consider this trial

Good fit: Adults (18+) currently taking one or more of the listed drugs (cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab, or enfortumab vedotin) who can perform finger‑prick self-sampling.

Not a fit: Patients who cannot perform finger‑prick self-sampling or who are not taking any of the listed drugs are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, patients could monitor drug levels from home to help personalize dosing, reduce clinic visits, and lower the chance of ineffective treatment or severe side effects.

How similar studies have performed: Therapeutic drug monitoring is established for several oral targeted therapies, but dried blood spot microsampling and home monitoring—particularly for immune checkpoint inhibitors—remain largely exploratory.

Eligibility criteria

Inclusion Criteria:

* Willing and able to provide informed consent;
* 18 years of age or older;
* Using one or more of the following drugs: Cabozantinib, Pazopanib, Sunitinib, Lenvatinib, Imatinib, Abiraterone, Enzalutamide, Nivolumab, Ipilimumab, Pembrolizumab, Atezolizumab, Bevacizumab or Enfortumab vedotin

Exclusion Criteria:

* Not able to sample themselves using a finger prick

Where this trial is running

Leiden, South Holland

• Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Tom Van Der Hulle, MD PhD

Conditions Drug Monitoring