NCT04833075

Real World Pharmacokinetics of Immune Checkpoint Inhibitors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Real-world pharmacokinetic data from cancer patients treated with immune checkpoint inhibitors (ICIs) are sparse. Moreover, pharmacokinetic parameters may be associated with response to ICI treatment and may act as a predictive or early response biomarker. Objective: To describe the real-world pharmacokinetics of ICIs in patients eligible for ICI treatment or already treated with ICIs. Study design: A low-interventional cross-sectional pharmacokinetic study. Study population: Patients treated with ICIs. Intervention: A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived. Main study parameters: Real- world pharmacokinetic parameters of ICIs: clearance, volume of distribution, serum exposure (serum concentration - time curve).

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	blood sampling	A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2021-04-06
• Last updated: 2023-05-31

Locations

1 site across 1 country: Netherlands